Elpipodect (MK-8189) Multiple Dose Study in Healthy Volun... | NCT02181803 | Trialant
NCT02181803
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Apr 29, 2026Actual
Enrollment
55Actual
Phase
Phase 1
Conditions
Schizophrenia
Interventions
Elpipodect
Placebo
Base Monotherapy
Countries
Not provided
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT02181803
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
8189-003
Secondary IDs
Not provided
Brief Title
Elpipodect (MK-8189) Multiple Dose Study in Healthy Volunteers and Schizophrenia Participants (MK-8189-003)
Official Title
A Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-8189 in Healthy Volunteers and in Schizophrenia Patients
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Apr 2026
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 5, 2014Actual
Primary Completion Date
Apr 23, 2015Actual
Completion Date
Apr 23, 2015Actual
First Submitted Date
Jul 2, 2014
First Submission Date that Met QC Criteria
Jul 3, 2014
First Posted Date
Jul 4, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 12, 2020
Results First Submitted that Met QC Criteria
Mar 12, 2020
Results First Posted Date
Mar 27, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 8, 2026
Last Update Posted Date
Apr 29, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This 3-part dose titration study will assess elpipodect safety, tolerability, pharmacokinetics (PK), and central nervous system activity. Part 1 (Panels A and B) will assess elpipodect administered as monotherapy in participants with schizophrenia. Part 2 (Panel C) will assess elpipodect administered as add-on to atypical antipsychotic treatment in participants with schizophrenia. Part 3 (Panel D) will assess monotherapy with elpipodect in healthy participants, including those of Japanese descent. The primary hypothesis is that there is at least one dose of elpipodect that is generally safe and well-tolerated which will have the desired PK parameters in participants with schizophrenia.
Detailed Description
As specified by Phase 1 protocol-flexible language in the protocol, modifications to the dose or dosing regimen can be made to achieve the scientific goals of the trial objectives and/or ensure appropriate safety of the trial participants. The proposed doses for each Part may be adjusted downward based on evaluation of safety, tolerability, and pharmacokinetic data observed in previous panels.
Conditions Module
Conditions
Schizophrenia
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
55Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part 1 Panel A & B Elpipodect Monotherapy 2-40 mg: Schizophrenic
Experimental
Participants with schizophrenia will receive monotherapy of elpipodect in escalating doses starting at 2 mg once daily (QD) up to 40 mg QD, depending on safety and tolerability
Drug: Elpipodect
Part 2 Panel C Elpipodect Add-on Therapy 2-20 mg: Schizophrenic
Experimental
Participants with schizophrenia will receive add-on therapy of elpipodect in escalating doses starting at 2 mg QD up to 20 mg QD, depending on safety and tolerability
Drug: Elpipodect
Drug: Base Monotherapy
Part 2 Panel C Elpipodect Add-on Therapy 4-20 mg: Schizophrenic
Experimental
Participants with schizophrenia will receive add-on therapy of elpipodect in escalating doses starting at 4 mg QD up to 20 mg QD, depending on safety and tolerability
Drug: Elpipodect
Drug: Base Monotherapy
Part 3 Panel D Elpipodect Monotherapy 2-16 mg: Healthy
Experimental
Healthy participants will receive monotherapy of elpipodect in escalating doses starting at 2 mg QD up to 16 mg QD, depending on safety and tolerability
Drug: Elpipodect
Part 1 Panel A & B Placebo Monotherapy: Schizophrenic
Placebo Comparator
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Elpipodect
Drug
MK-8189, oral, 2 mg and/or 10 mg tablets, taken QD for a total daily dose of 2 mg, 4 mg, 8 mg, 10 mg, 12 mg, 14 mg, 16 mg, 20 mg, or 40 mg
Part 1 Panel A & B Elpipodect Monotherapy 2-40 mg: Schizophrenic
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Plasma Concentration at 24 Hours Post-dose (C24hr) of MK-8189 in Schizophrenia Participants
C24hr was defined as the concentration of MK-8189 observed in plasma at the 24-hour nominal sampling time after administration of MK-8189. In participants receiving MK-8189, blood samples were collected pre-dose and 24 hours post-dose to estimate C24hr following MK-8189 administration. As specified by the protocol, C24hr was analyzed by part, dose and dosing schedule. Due to differing dosing schedules, some time points were not applicable for certain arms/doses as indicated by zero participants analyzed entered in the table. Per protocol, healthy participants (Part 3) and participants receiving placebo were excluded from C24 analysis.
Day 1, 4, 8, 11 and 14 pre-dose and 24 hours post-dose
Area Under the Plasma-concentration Curve at Zero to 24 Hours Post-dose (AUC[0-24hr]) of MK-8189 in Schizophrenia Participants
AUC was defined as a measure of MK-8189 exposure that was calculated as the product of plasma drug concentration and time. The linear-up-log down rule was used to estimate AUC. Blood samples were collected pre-dose and up to 24 hours post-dose to estimate AUC(0-24hr) following MK-8189 administration. As specified by the protocol, AUC(0-24hr) was analyzed by part, dose and dosing schedule. Due to differing dosing schedules, some time points were not applicable for certain arms/doses as indicated by zero participants analyzed entered in the table. Per protocol, healthy participants (Part 3) and participants receiving placebo were excluded from AUC(0-24hr) analysis.
Day 1 pre-dose and 2, 3, 4, 6, 8, 10, 12, 16, 24 hours post-dose; Days 4, 8, 11 pre-dose and 6, 10, 16, 24 hours post-dose; Day 14 pre-dose and 2, 3, 4, 6, 8, 10, 12, 16, 20, 24 hours post-dose
Maximum Observed Post-dose Plasma Concentration (Cmax) of MK-8189 in Schizophrenia Participants
Cmax was defined as the maximum concentration of MK-8189 observed in plasma. Blood samples were collected pre-dose and up to 48 hours post-dose at multiple time points to estimate Cmax following MK-8189 administration. As specified by the protocol, Cmax was analyzed by part, dose and dosing schedule. Due to differing dosing schedules, some time points were not applicable for certain arms/doses as indicated by zero participants analyzed entered in the table. Per protocol, healthy participants (Part 3) and participants receiving placebo were excluded from Cmax analysis.
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline at Day 13 in Mismatched Negativity (MMN) Peak Amplitude in Monotherapy MK-8189-treated Schizophrenia Participants
MMN is a response to deviant tone (stimuli) measured in electroencephalogram (EEG) signals. Difference in deviant EEG waveform amplitude from standard amplitude over time indicates MMN; this difference at peak waveform is MMN peak amplitude. Schizophrenic participants show reduced response to deviant stimuli. Peak amplitude change from baseline (Day -1) to Day 13 was reported. A higher change indicates improved response to deviant stimuli. Scalp EEG signals were collected using a standard system array of 19 electrodes denoted by nomenclature of scalp placement: C3, C4, Cz, F3, F4, F7, F8, Fp1, Fp2, Fz, O1, O2, P3, P4, Pz, T3, T4, T5, T6. As specified by the protocol, MK-8189 add-on therapy schizophrenia participants (Part 2), healthy participants (Part 3) and all placebo-treated participants were excluded from MMN analyses. Per protocol, MMN analyses were planned and executed in all schizophrenia participants receiving MK-8189 monotherapy, irrespective of different dosing schedules.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
INCLUSION CRITERIA FOR SCHIZOPHRENIA PARTICIPANTS
Male or non-pregnant and non-breast feeding female. If participant is male with a female partner of child-bearing potential, participant must agree to use a medically acceptable method of contraception during the trial and for 120 days after the last dose of trial drug. If their partner is pregnant, males must agree to use a condom
Body Mass Index (BMI) ≥ 18.5 and ≤ 40 kg/m^2
Meet diagnostic criteria for schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria with the onset of the first episode being no less than 2 years prior to study entry
Be in the non-acute phase of illness and clinically stable for 3 months prior to screening
History of receiving and tolerating antipsychotic medication within the usual dose range employed for schizophrenia
Participants with hypothyroidism, diabetes, high blood pressure, chronic respiratory conditions or other mild forms of these medical conditions could be considered as candidates for study enrollment if their condition is stable and the prescribed dose and regimen of medication is stable for at least 3 months prior to screening and there are no expected changes in comedication during the study
Has a negative urinary drug screen at screening
INCLUSION CRITERIA FOR HEALTHY PARTICIPANTS
Male, or non-pregnant and non-breast feeding female of Japanese or non-Japanese descent. If participant is male with a female partner of child-bearing potential, participant must agree to use a medically acceptable method of contraception during the trial and for 120 days after the last dose of trial drug. If their partner is pregnant, males must agree to use a condom
Body Mass Index (BMI) ≥ 18.5 and ≤ 35 kg/m^2
In good health
Nonsmoker and/or has not used nicotine or nicotine-containing products (e.g., nicotine patch) for at least approximately 3 months
Has a negative urinary drug screen at screening
Exclusion Criteria:
EXCLUSION CRITERIA FOR SCHIZOPHRENIA PARTICIPANTS
DSM-IV axis I psychiatric diagnosis other than schizophrenia or schizoaffective disorder within one month of screening
Has evidence or history of mental retardation, borderline personality disorder, anxiety disorder, or organic brain syndrome
History of neuroleptic malignant syndrome or moderate to severe tardive dyskinesia
Untreated or uncompensated clinically significant renal, endocrine, hepatic, respiratory, gastrointestinal, psychiatric, neurologic, cardiovascular, hematological, immunological or cerebrovascular disease, malignance, allergic disease or other chronic and/or degenerative process at screening
Has a history of cancer (malignancy) with certain exceptions
Treatment with clozapine for schizophrenia or treatment with monoamine oxidase inhibitors within 3 months of screening
Received a parenteral depot antipsychotic medication within 3 months of screening
Participated in another investigational study within 4 weeks, prior to screening
EXCLUSION CRITERIA FOR HEALTHY PARTICIPANTS
History of clinically significant endocrine, gastrointestinal, cardiovascular (including hypertension, angina, coronary artery disease, valvular disease, heart rate or rhythm abnormalities), hematological, hepatic, immunological, renal, respiratory, genitourinary or major neurological (including stroke and chronic seizures) abnormalities or diseases
Mentally or legally incapacitated
History of clinically diagnosed depression, anxiety disorder, or any history of psychiatric disorders having required drug treatment or hospitalization
History of cancer (malignancy)
Unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies throughout the trial
Participated in another investigational study within 4 weeks, prior to screening
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
60 Years
Standard Ages
Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Medical Director
Merck Sharp & Dohme LLC
Study Director
Locations
Not provided
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Forty-three schizophrenia participants and 12 healthy volunteers were randomized to either MK-8189 or placebo in Part 1 Panels A & B, Part 2 Panel C, or Part 3 Panel D. MK-8189 dose and schedule were modified for participants based on tolerability.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1 Panel A & B MK-8189 Monotherapy 2-4 mg: Schizophrenic
Participant with Schizophrenia received monotherapy of MK-8189 in escalating doses: 2 mg once daily (QD) Days 1-4 and 4 mg QD Days 5-14
FG001
Part 1 Panel A & B MK-8189 Monotherapy 2-12 mg: Schizophrenic
Participants with Schizophrenia received monotherapy of MK-8189 in escalating doses: 2 mg QD Days 1-4, 4 mg QD Days 5-8, 8 mg QD Days 9-11, and 12 mg QD Days 12-14
FG002
Part 1 Panel A & B Placebo Monotherapy: Schizophrenic
Participants with Schizophrenia received dose-matched placebo to MK-8189 monotherapy on Days 1-14
FG003
Part 2 Panel C MK-8189 Add-on Therapy 2-12 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy of MK-8189 in escalating doses: 2 mg QD Days 1-4, 4 mg QD Days 5-8, 8 mg QD Days 9-11, and 12 mg QD Days 12-14
FG004
Part 2 Panel C MK-8189 Add-on Therapy 4-16 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy of MK-8189 in escalating doses: 4 mg QD Days 1-4, 8 mg QD Days 5-8, 12 mg QD Days 9-11, and 16 mg QD Days 12-14
FG005
Part 2 Panel C Placebo Add-on Therapy: Schizophrenic
Participants with Schizophrenia received dose-matched placebo to MK-8189 add-on therapy on Days 1-14
FG006
Part 3 Panel D MK-8189 Monotherapy 2-12 mg: Healthy
Healthy participants received monotherapy of MK-8189 in escalating doses: 2 mg QD Days 1-4, 4 mg QD Days 5-8, 8 mg QD Days 9-11, and 12 mg QD Days 12-14
FG007
Part 3 Panel D MK-8189 Monotherapy 2-8 mg: Healthy
Healthy participant received monotherapy of MK-8189 in escalating doses: 2 mg QD Days 1-4, 4 mg QD Days 5-8, and 8 mg QD days 9-14
FG008
Part 3 Panel D Placebo Monotherapy: Healthy
Healthy participants received dose-matched placebo to MK-8189 monotherapy on Days 1-14
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG0001 subjects
FG00113 subjects
FG0024 subjects
FG00313 subjects
FG0046 subjects
FG0056 subjects
FG0069 subjects
FG0071 subjects
FG0082 subjects
COMPLETED
FG0001 subjects
FG0019 subjects
FG0024 subjects
FG00311 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0014 subjects
FG0020 subjects
FG0032 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1 Panel A & B MK-8189 Monotherapy 2-4 mg: Schizophrenic
Participant with Schizophrenia received monotherapy of MK-8189 in escalating doses: 2 mg once daily (QD) Days 1-4 and 4 mg QD Days 5-14
BG001
Part 1 Panel A & B MK-8189 Monotherapy 2-12 mg: Schizophrenic
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Plasma Concentration at 24 Hours Post-dose (C24hr) of MK-8189 in Schizophrenia Participants
C24hr was defined as the concentration of MK-8189 observed in plasma at the 24-hour nominal sampling time after administration of MK-8189. In participants receiving MK-8189, blood samples were collected pre-dose and 24 hours post-dose to estimate C24hr following MK-8189 administration. As specified by the protocol, C24hr was analyzed by part, dose and dosing schedule. Due to differing dosing schedules, some time points were not applicable for certain arms/doses as indicated by zero participants analyzed entered in the table. Per protocol, healthy participants (Part 3) and participants receiving placebo were excluded from C24 analysis.
Schizophrenia participants who received ≥1 dose of MK-8189, complied with the protocol and had C24 data available for Days 1, 4, 8, 11, or 14. Due to differing dosing schedules, some time points were not applicable for some arms (shown by 0 participants analyzed). Per protocol, healthy participants (Part 3) and placebo arms were excluded.
Posted
Geometric Mean
Geometric Coefficient of Variation
nM
Day 1, 4, 8, 11 and 14 pre-dose and 24 hours post-dose
Adverse Events Module
Frequency Threshold
5
Time Frame
Up to Day 28; all-cause mortality was assessed for up to ~9 months
Description
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part 1 Panel A & B MK-8189 Monotherapy 2 mg: Schizophrenic
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Gastroenteritis
Infections and infestations
MedDRA 18.0
Systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Tinnitus
Ear and labyrinth disorders
MedDRA 18.0
Systematic Assessment
More Info Module
Limitations and Caveats
There were some missing event markers in EEG recordings during data collection, these were imputed for the MMN analyses.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
1-800-672-6372
ClinicalTrialsDisclosure@merck.com
Jul 10, 2026
Removed Countries
United States
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D012559
Schizophrenia
Ancestor Terms
ID
Term
D019967
Schizophrenia Spectrum and Other Psychotic Disorders
D001523
Mental Disorders
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
MeSH Terms
ID
Term
C000729358
MK-8189
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Participants with schizophrenia will receive dose-matched placebo to elpipodect monotherapy
Drug: Placebo
Part 2 Panel C Placebo Add-on Therapy: Schizophrenic
Placebo Comparator
Participants with schizophrenia will receive dose-matched placebo to elpipodect add-on therapy
Drug: Placebo
Drug: Base Monotherapy
Part 3 Panel D Placebo Monotherapy: Healthy
Placebo Comparator
Healthy participants will receive dose-matched placebo to elpipodect monotherapy
Drug: Placebo
Part 2 Panel C Elpipodect Add-on Therapy 2-20 mg: Schizophrenic
Part 2 Panel C Elpipodect Add-on Therapy 4-20 mg: Schizophrenic
Part 3 Panel D Elpipodect Monotherapy 2-16 mg: Healthy
Part 1 Panel A & B Placebo Monotherapy: Schizophrenic
Part 2 Panel C Placebo Add-on Therapy: Schizophrenic
Part 3 Panel D Placebo Monotherapy: Healthy
Base Monotherapy
Drug
For Part 2 only: participants need to be on monotherapy with an atypical antipsychotic medication (eg, Olanzapine, Quetiapine, Paliperidone, Asenapine, Iloperidone, Aripirprazole, Lurasidone, Risperidone [not to exceed daily dose of 6 mg], or Ziprasidone.) The participant should be on a stable and well tolerated treatment regimen for at least 2 months prior to screening. NOTE: Clozapine is not allowed.
Part 2 Panel C Elpipodect Add-on Therapy 2-20 mg: Schizophrenic
Part 2 Panel C Elpipodect Add-on Therapy 4-20 mg: Schizophrenic
Part 2 Panel C Placebo Add-on Therapy: Schizophrenic
Day 1 pre-dose and 2, 3, 4, 6, 8, 10, 12, 16, 24 hours post-dose; Days 4, 8, 11 pre-dose and 6, 10, 16, 24 hours post-dose; Day 14 pre-dose and 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 36, 48 hours post-dose
Time Post-dose at Which the Maximum Plasma Concentration (Tmax) of MK-8189 Was Observed in Schizophrenia Participants
Tmax was defined as the time required post dose to reach a maximum plasma concentration of MK-8189. It was estimated as the actual sampling time at the highest MK-8189 plasma concentration. Blood samples were collected pre-dose and up to 48 hours post-dose at multiple time points to estimate Tmax following MK-8189 administration. As specified by the protocol, Tmax was analyzed by part, dose and dosing schedule. Due to differing dosing schedules, some time points were not applicable for certain arms/doses as indicated by zero participants analyzed entered in the table. Per protocol, healthy participants (Part 3) and participants receiving placebo were excluded from Tmax analysis.
Day 1 pre-dose and 2, 3, 4, 6, 8, 10, 12, 16, 24 hours post-dose; Days 4, 8, 11 pre-dose and 6, 10, 16, 24 hours post-dose; Day 14 pre-dose and 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 36, 48 hours post-dose
Time Required for Plasma Concentration of MK-8189 to Decrease by Half (Apparent t1/2) in Schizophrenia Participants on Day 14
t1/2 was defined as the time required to divide the MK-8189 plasma concentration by half after reaching pseudo-equilibrium. At least three quantifiable post-Cmax, terminal phase concentrations collected were used to calculate the apparent t1/2. Blood samples were collected pre-dose and up to 48 hours post-dose at multiple time points on Day 14 to estimate t1/2 following MK-8189 administration. As specified by the protocol, t1/2 was analyzed by part, dose and dosing schedule. Due to differing dosing schedules, the Day 14 timepoint was not applicable for certain arms/doses as indicated by zero participants analyzed entered in the table. Per protocol, healthy participants (Part 3) and participants receiving placebo were excluded from t1/2 analysis.
Day 14 pre-dose and 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 36, 48 hours post-dose
Number of Participants Experiencing an Adverse Event (AE)
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The number of participants who experienced at least one AE were reported.
Up to Day 28
Number of Participants Who Discontinue From Study Treatment Due to an AE
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The number of participants who discontinued study treatment due to an AE were reported.
Up to Day 14
Baseline and Day 13
Change From Baseline at Day 13 in Mismatched Negativity (MMN) Area Under Curve (AUC) in Monotherapy MK-8189-treated Schizophrenia Participants
MMN is a response to deviant tone (stimuli) measured in EEG signals. Difference in deviant EEG waveform amplitude from standard amplitude over time indicates MMN; AUC was measured as the product of MMN amplitude and time. Schizophrenic participants show reduced response to deviant stimuli. AUC change from baseline (Day -1) to Day 13 was reported. A higher change indicates improved response to deviant stimuli. Scalp EEG signals were collected using a standard system array of 19 electrodes denoted by nomenclature of scalp placement: C3, C4, Cz, F3, F4, F7, F8, Fp1, Fp2, Fz, O1, O2, P3, P4, Pz, T3, T4, T5, T6. As specified by the protocol, MK-8189 add-on therapy schizophrenia participants (Part 2), healthy participants (Part 3), and all placebo-treated participants were excluded from MMN analyses. Per protocol, MMN analyses were planned and executed in all schizophrenia participants receiving MK-8189 monotherapy, irrespective of different dosing schedules.
Baseline and Day 13
6 subjects
FG0056 subjects
FG0068 subjects
FG0070 subjects
FG0082 subjects
0 subjects
FG0050 subjects
FG0061 subjects
FG0071 subjects
FG0080 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
Adverse Event
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
Participants with Schizophrenia received monotherapy of MK-8189 in escalating doses: 2 mg QD Days 1-4, 4 mg QD Days 5-8, 8 mg QD Days 9-11, and 12 mg QD Days 12-14.
BG002
Part 1 Panel A & B Placebo Monotherapy: Schizophrenic
Participants with Schizophrenia received dose-matched placebo to MK-8189 monotherapy on Days 1-14
BG003
Part 2 Panel C MK-8189 Add-on Therapy 2-12 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy of MK-8189 in escalating doses: 2 mg QD Days 1-4, 4 mg QD Days 5-8, 8 mg QD Days 9-11, and 12 mg QD Days 12-14
BG004
Part 2 Panel C MK-8189 Add-on Therapy 4-16 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy of MK-8189 in escalating doses: 4 mg QD Days 1-4, 8 mg QD Days 5-8, 12 mg QD Days 9-11, and 16 mg QD Days 12-14
BG005
Part 2 Panel C Placebo Add-on Therapy: Schizophrenic
Participants with Schizophrenia received dose-matched placebo to MK-8189 add-on therapy on Days 1-14
BG006
Part 3 Panel D MK-8189 Monotherapy 2-12 mg: Healthy
Healthy participants received monotherapy of MK-8189 in escalating doses: 2 mg QD Days 1-4, 4 mg QD Days 5-8, 8 mg QD Days 9-11, and 12 mg QD Days 12-14
BG007
Part 3 Panel D MK-8189 Monotherapy 2-8 mg: Healthy
Healthy participant received monotherapy of MK-8189 in escalating doses: 2 mg QD Days 1-4, 4 mg QD Days 5-8, and 8 mg QD days 9-14
BG008
Part 3 Panel D Placebo Monotherapy: Healthy
Healthy participants received dose-matched placebo to MK-8189 monotherapy on Days 1-14
BG009
Total
Total of all reporting groups
1
BG00113
BG0024
BG00313
BG0046
BG0056
BG0069
BG0071
BG0082
BG00955
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00021.0± NAMeasure of dispersion could not be estimated due to low number of participants analyzed
BG00144.2± 8.7
BG00244.0± 9.0
BG00343.8± 8.9
BG00441.7± 14.7
BG00544.5± 7.6
BG00643.3± 8.7
BG00755.0± NAMeasure of dispersion could not be estimated due to low number of participants analyzed
BG00843.0± 5.7
BG00943.4± 9.4
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0013
BG0021
BG0036
BG0043
BG0051
BG0062
BG0071
BG0080
BG00917
Male
BG0001
BG00110
BG0023
BG0037
BG004
ID
Title
Description
OG000
Part 1 Panel A & B MK-8189 Monotherapy 2 mg: Schizophrenic
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
OG001
Part 1 Panel A & B MK-8189 Monotherapy 4 mg: Schizophrenic
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 4 mg QD starting on Day 5 and continuing up to Day 14, based on participant tolerability
OG002
Part 1 Panel A & B MK-8189 Monotherapy 8 mg: Schizophrenic
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 8 mg QD starting on day 9 and continuing up to Day 11, based on participant tolerability
OG003
Part 1 Panel A & B MK-8189 Monotherapy 12 mg: Schizophrenic
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 12 mg QD starting on Day 12 and continuing up to Day 14, based on participant tolerability
OG004
Part 1 Panel A & B Placebo Monotherapy: Schizophrenic
Participants with Schizophrenia received dose-matched placebo to MK-8189 monotherapy on Days 1-14
OG005
Part 2 Panel C MK-8189 Add-on Therapy 2 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
OG006
Part 2 Panel C MK-8189 Add-on Therapy 4 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 4 mg QD starting on Day 1 and continuing up to Day 8, based on participant tolerability
OG007
Part 2 Panel C MK-8189 Add-on Therapy 8 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 8 mg QD starting on Day 5 and continuing up to Day 11, based on participant tolerability
OG008
Part 2 Panel C MK-8189 Add-on Therapy 12 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 12 mg QD starting on Day 9 and continuing up to Day 14, based on participant tolerability
OG009
Part 2 Panel C MK-8189 Add-on Therapy 16 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 16 mg QD starting on Day 12 and continuing up to day 14, based on participant tolerability
OG010
Part 2 Panel C Placebo Add-on Therapy: Schizophrenic
Participants with Schizophrenia received dose-matched placebo to MK-8189 add-on therapy on Days 1-14
OG011
Part 3 Panel D MK-8189 Monotherapy 2 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
OG012
Part 3 Panel D MK-8189 Monotherapy 4 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 4 mg QD starting on Day 5 and continuing up to Day 8, based on participant tolerability
OG013
Part 3 Panel D MK-8189 Monotherapy 8 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 8 mg QD starting on Day 9 and continuing up to Day 14, based on participant tolerability
OG014
Part 3 Panel D MK-8189 Monotherapy 12 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 12 mg QD starting on Day 12 and continuing up to Day 14, based on participant tolerability
OG015
Part 3 Panel D Placebo Monotherapy: Healthy
Healthy participants received dose-matched placebo to MK-8189 monotherapy on Days 1-14
Units
Counts
Participants
OG00013
OG00112
OG00210
OG0039
OG0040
OG00513
OG00611
OG00711
OG00811
OG0096
OG0100
OG0110
OG0120
OG0130
OG0140
OG0150
Title
Denominators
Categories
Day 1
ParticipantsOG00013
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG00513
ParticipantsOG0066
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
Title
Measurements
OG00067.0± 31.7
OG00560.5± 37.1
OG006161± 39.8
Day 4
ParticipantsOG00012
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Day 8
ParticipantsOG0000
ParticipantsOG00112
ParticipantsOG0020
ParticipantsOG0030
Day 11
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG00210
ParticipantsOG0030
Day 14
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0039
Primary
Area Under the Plasma-concentration Curve at Zero to 24 Hours Post-dose (AUC[0-24hr]) of MK-8189 in Schizophrenia Participants
AUC was defined as a measure of MK-8189 exposure that was calculated as the product of plasma drug concentration and time. The linear-up-log down rule was used to estimate AUC. Blood samples were collected pre-dose and up to 24 hours post-dose to estimate AUC(0-24hr) following MK-8189 administration. As specified by the protocol, AUC(0-24hr) was analyzed by part, dose and dosing schedule. Due to differing dosing schedules, some time points were not applicable for certain arms/doses as indicated by zero participants analyzed entered in the table. Per protocol, healthy participants (Part 3) and participants receiving placebo were excluded from AUC(0-24hr) analysis.
Schizophrenia participants who received ≥1 dose of MK-8189, complied with the protocol and had AUC(0-24hr) data available for Days 1, 4, 8, 11, or 14. Due to differing dosing schedules, some time points were not applicable for some arms (shown by 0 participants analyzed). Per protocol, healthy participants (Part 3) and placebo arms were excluded.
Posted
Geometric Mean
Geometric Coefficient of Variation
nM*hr
Day 1 pre-dose and 2, 3, 4, 6, 8, 10, 12, 16, 24 hours post-dose; Days 4, 8, 11 pre-dose and 6, 10, 16, 24 hours post-dose; Day 14 pre-dose and 2, 3, 4, 6, 8, 10, 12, 16, 20, 24 hours post-dose
ID
Title
Description
OG000
Part 1 Panel A & B MK-8189 Monotherapy 2 mg: Schizophrenic
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
OG001
Part 1 Panel A & B MK-8189 Monotherapy 4 mg: Schizophrenic
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 4 mg QD starting on Day 5 and continuing up to Day 14, based on participant tolerability
OG002
Part 1 Panel A & B MK-8189 Monotherapy 8 mg: Schizophrenic
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 8 mg QD starting on day 9 and continuing up to Day 11, based on participant tolerability
OG003
Part 1 Panel A & B MK-8189 Monotherapy 12 mg: Schizophrenic
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 12 mg QD starting on Day 12 and continuing up to Day 14, based on participant tolerability
OG004
Part 1 Panel A & B Placebo Monotherapy: Schizophrenic
Participants with Schizophrenia received dose-matched placebo to MK-8189 monotherapy on Days 1-14
OG005
Part 2 Panel C MK-8189 Add-on Therapy 2 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
OG006
Part 2 Panel C MK-8189 Add-on Therapy 4 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 4 mg QD starting on Day 1 and continuing up to Day 8, based on participant tolerability
OG007
Part 2 Panel C MK-8189 Add-on Therapy 8 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 8 mg QD starting on Day 5 and continuing up to Day 11, based on participant tolerability
OG008
Part 2 Panel C MK-8189 Add-on Therapy 12 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 12 mg QD starting on Day 9 and continuing up to Day 14, based on participant tolerability
OG009
Part 2 Panel C MK-8189 Add-on Therapy 16 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 16 mg QD starting on Day 12 and continuing up to day 14, based on participant tolerability
OG010
Part 2 Panel C Placebo Add-on Therapy: Schizophrenic
Participants with Schizophrenia received dose-matched placebo to MK-8189 add-on therapy on Days 1-14
OG011
Part 3 Panel D MK-8189 Monotherapy 2 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
OG012
Part 3 Panel D MK-8189 Monotherapy 4 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 4 mg QD starting on Day 5 and continuing up to Day 8, based on participant tolerability
OG013
Part 3 Panel D MK-8189 Monotherapy 8 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 8 mg QD starting on Day 9 and continuing up to Day 14, based on participant tolerability
OG014
Part 3 Panel D MK-8189 Monotherapy 12 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 12 mg QD starting on Day 12 and continuing up to Day 14, based on participant tolerability
OG015
Part 3 Panel D Placebo Monotherapy: Healthy
Healthy participants received dose-matched placebo to MK-8189 monotherapy on Days 1-14
Units
Counts
Participants
OG00013
OG00112
OG00210
OG003
Title
Denominators
Categories
Day 1
ParticipantsOG00013
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Primary
Maximum Observed Post-dose Plasma Concentration (Cmax) of MK-8189 in Schizophrenia Participants
Cmax was defined as the maximum concentration of MK-8189 observed in plasma. Blood samples were collected pre-dose and up to 48 hours post-dose at multiple time points to estimate Cmax following MK-8189 administration. As specified by the protocol, Cmax was analyzed by part, dose and dosing schedule. Due to differing dosing schedules, some time points were not applicable for certain arms/doses as indicated by zero participants analyzed entered in the table. Per protocol, healthy participants (Part 3) and participants receiving placebo were excluded from Cmax analysis.
Schizophrenia participants who received ≥1 dose of MK-8189, complied with the protocol and had Cmax data available for Days 1, 4, 8, 11, or 14. Due to differing dosing schedules, some time points were not applicable for some arms (shown by 0 participants analyzed). Per protocol, healthy participants (Part 3) and placebo arms were excluded.
Posted
Geometric Mean
Geometric Coefficient of Variation
nM
Day 1 pre-dose and 2, 3, 4, 6, 8, 10, 12, 16, 24 hours post-dose; Days 4, 8, 11 pre-dose and 6, 10, 16, 24 hours post-dose; Day 14 pre-dose and 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 36, 48 hours post-dose
ID
Title
Description
OG000
Part 1 Panel A & B MK-8189 Monotherapy 2 mg: Schizophrenic
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
OG001
Part 1 Panel A & B MK-8189 Monotherapy 4 mg: Schizophrenic
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 4 mg QD starting on Day 5 and continuing up to Day 14, based on participant tolerability
OG002
Part 1 Panel A & B MK-8189 Monotherapy 8 mg: Schizophrenic
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 8 mg QD starting on day 9 and continuing up to Day 11, based on participant tolerability
OG003
Part 1 Panel A & B MK-8189 Monotherapy 12 mg: Schizophrenic
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 12 mg QD starting on Day 12 and continuing up to Day 14, based on participant tolerability
OG004
Part 1 Panel A & B Placebo Monotherapy: Schizophrenic
Participants with Schizophrenia received dose-matched placebo to MK-8189 monotherapy on Days 1-14
OG005
Part 2 Panel C MK-8189 Add-on Therapy 2 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
OG006
Part 2 Panel C MK-8189 Add-on Therapy 4 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 4 mg QD starting on Day 1 and continuing up to Day 8, based on participant tolerability
OG007
Part 2 Panel C MK-8189 Add-on Therapy 8 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 8 mg QD starting on Day 5 and continuing up to Day 11, based on participant tolerability
OG008
Part 2 Panel C MK-8189 Add-on Therapy 12 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 12 mg QD starting on Day 9 and continuing up to Day 14, based on participant tolerability
OG009
Part 2 Panel C MK-8189 Add-on Therapy 16 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 16 mg QD starting on Day 12 and continuing up to day 14, based on participant tolerability
OG010
Part 2 Panel C Placebo Add-on Therapy: Schizophrenic
Participants with Schizophrenia received dose-matched placebo to MK-8189 add-on therapy on Days 1-14
OG011
Part 3 Panel D MK-8189 Monotherapy 2 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
OG012
Part 3 Panel D MK-8189 Monotherapy 4 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 4 mg QD starting on Day 5 and continuing up to Day 8, based on participant tolerability
OG013
Part 3 Panel D MK-8189 Monotherapy 8 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 8 mg QD starting on Day 9 and continuing up to Day 14, based on participant tolerability
OG014
Part 3 Panel D MK-8189 Monotherapy 12 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 12 mg QD starting on Day 12 and continuing up to Day 14, based on participant tolerability
OG015
Part 3 Panel D Placebo Monotherapy: Healthy
Healthy participants received dose-matched placebo to MK-8189 monotherapy on Days 1-14
Units
Counts
Participants
OG00013
OG00112
OG00210
OG003
Title
Denominators
Categories
Day 1
ParticipantsOG00013
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Primary
Time Post-dose at Which the Maximum Plasma Concentration (Tmax) of MK-8189 Was Observed in Schizophrenia Participants
Tmax was defined as the time required post dose to reach a maximum plasma concentration of MK-8189. It was estimated as the actual sampling time at the highest MK-8189 plasma concentration. Blood samples were collected pre-dose and up to 48 hours post-dose at multiple time points to estimate Tmax following MK-8189 administration. As specified by the protocol, Tmax was analyzed by part, dose and dosing schedule. Due to differing dosing schedules, some time points were not applicable for certain arms/doses as indicated by zero participants analyzed entered in the table. Per protocol, healthy participants (Part 3) and participants receiving placebo were excluded from Tmax analysis.
Schizophrenia participants who received ≥1 dose of MK-8189, complied with the protocol and had Tmax data available for Days 1, 4, 8, 11, or 14. Due to differing dosing schedules, some time points were not applicable for some arms (shown by 0 participants analyzed). Per protocol, healthy participants (Part 3) and placebo arms were excluded.
Posted
Median
Full Range
hr
Day 1 pre-dose and 2, 3, 4, 6, 8, 10, 12, 16, 24 hours post-dose; Days 4, 8, 11 pre-dose and 6, 10, 16, 24 hours post-dose; Day 14 pre-dose and 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 36, 48 hours post-dose
ID
Title
Description
OG000
Part 1 Panel A & B MK-8189 Monotherapy 2 mg: Schizophrenic
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
OG001
Part 1 Panel A & B MK-8189 Monotherapy 4 mg: Schizophrenic
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 4 mg QD starting on Day 5 and continuing up to Day 14, based on participant tolerability
OG002
Part 1 Panel A & B MK-8189 Monotherapy 8 mg: Schizophrenic
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 8 mg QD starting on day 9 and continuing up to Day 11, based on participant tolerability
OG003
Part 1 Panel A & B MK-8189 Monotherapy 12 mg: Schizophrenic
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 12 mg QD starting on Day 12 and continuing up to Day 14, based on participant tolerability
OG004
Part 1 Panel A & B Placebo Monotherapy: Schizophrenic
Participants with Schizophrenia received dose-matched placebo to MK-8189 monotherapy on Days 1-14
OG005
Part 2 Panel C MK-8189 Add-on Therapy 2 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
OG006
Part 2 Panel C MK-8189 Add-on Therapy 4 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 4 mg QD starting on Day 1 and continuing up to Day 8, based on participant tolerability
OG007
Part 2 Panel C MK-8189 Add-on Therapy 8 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 8 mg QD starting on Day 5 and continuing up to Day 11, based on participant tolerability
OG008
Part 2 Panel C MK-8189 Add-on Therapy 12 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 12 mg QD starting on Day 9 and continuing up to Day 14, based on participant tolerability
OG009
Part 2 Panel C MK-8189 Add-on Therapy 16 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 16 mg QD starting on Day 12 and continuing up to day 14, based on participant tolerability
OG010
Part 2 Panel C Placebo Add-on Therapy: Schizophrenic
Participants with Schizophrenia received dose-matched placebo to MK-8189 add-on therapy on Days 1-14
OG011
Part 3 Panel D MK-8189 Monotherapy 2 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
OG012
Part 3 Panel D MK-8189 Monotherapy 4 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 4 mg QD starting on Day 5 and continuing up to Day 8, based on participant tolerability
OG013
Part 3 Panel D MK-8189 Monotherapy 8 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 8 mg QD starting on Day 9 and continuing up to Day 14, based on participant tolerability
OG014
Part 3 Panel D MK-8189 Monotherapy 12 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 12 mg QD starting on Day 12 and continuing up to Day 14, based on participant tolerability
OG015
Part 3 Panel D Placebo Monotherapy: Healthy
Healthy participants received dose-matched placebo to MK-8189 monotherapy on Days 1-14
Units
Counts
Participants
OG00013
OG00112
OG00210
OG003
Title
Denominators
Categories
Day 1
ParticipantsOG00013
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Primary
Time Required for Plasma Concentration of MK-8189 to Decrease by Half (Apparent t1/2) in Schizophrenia Participants on Day 14
t1/2 was defined as the time required to divide the MK-8189 plasma concentration by half after reaching pseudo-equilibrium. At least three quantifiable post-Cmax, terminal phase concentrations collected were used to calculate the apparent t1/2. Blood samples were collected pre-dose and up to 48 hours post-dose at multiple time points on Day 14 to estimate t1/2 following MK-8189 administration. As specified by the protocol, t1/2 was analyzed by part, dose and dosing schedule. Due to differing dosing schedules, the Day 14 timepoint was not applicable for certain arms/doses as indicated by zero participants analyzed entered in the table. Per protocol, healthy participants (Part 3) and participants receiving placebo were excluded from t1/2 analysis.
Schizophrenia participants who received ≥1 dose of MK-8189, complied with the protocol and had t1/2 data available for Day 14. Due to differing dosing schedules, some time points were not applicable for some arms/doses (indicated by zero participants analyzed). Per protocol healthy participants (Part 3) and placebo arms were excluded.
Posted
Geometric Mean
Geometric Coefficient of Variation
hr
Day 14 pre-dose and 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 36, 48 hours post-dose
ID
Title
Description
OG000
Part 1 Panel A & B MK-8189 Monotherapy 2 mg: Schizophrenic
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
OG001
Part 1 Panel A & B MK-8189 Monotherapy 4 mg: Schizophrenic
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 4 mg QD starting on Day 5 and continuing up to Day 14, based on participant tolerability
OG002
Part 1 Panel A & B MK-8189 Monotherapy 8 mg: Schizophrenic
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 8 mg QD starting on day 9 and continuing up to Day 11, based on participant tolerability
OG003
Part 1 Panel A & B MK-8189 Monotherapy 12 mg: Schizophrenic
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 12 mg QD starting on Day 12 and continuing up to Day 14, based on participant tolerability
OG004
Part 1 Panel A & B Placebo Monotherapy: Schizophrenic
Participants with Schizophrenia received dose-matched placebo to MK-8189 monotherapy on Days 1-14
OG005
Part 2 Panel C MK-8189 Add-on Therapy 2 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
OG006
Part 2 Panel C MK-8189 Add-on Therapy 4 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 4 mg QD starting on Day 1 and continuing up to Day 8, based on participant tolerability
OG007
Part 2 Panel C MK-8189 Add-on Therapy 8 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 8 mg QD starting on Day 5 and continuing up to Day 11, based on participant tolerability
OG008
Part 2 Panel C MK-8189 Add-on Therapy 12 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 12 mg QD starting on Day 9 and continuing up to Day 14, based on participant tolerability
OG009
Part 2 Panel C MK-8189 Add-on Therapy 16 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 16 mg QD starting on Day 12 and continuing up to day 14, based on participant tolerability
OG010
Part 2 Panel C Placebo Add-on Therapy: Schizophrenic
Participants with Schizophrenia received dose-matched placebo to MK-8189 add-on therapy on Days 1-14
OG011
Part 3 Panel D MK-8189 Monotherapy 2 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
OG012
Part 3 Panel D MK-8189 Monotherapy 4 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 4 mg QD starting on Day 5 and continuing up to Day 8, based on participant tolerability
OG013
Part 3 Panel D MK-8189 Monotherapy 8 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 8 mg QD starting on Day 9 and continuing up to Day 14, based on participant tolerability
OG014
Part 3 Panel D MK-8189 Monotherapy 12 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 12 mg QD starting on Day 12 and continuing up to Day 14, based on participant tolerability
OG015
Part 3 Panel D Placebo Monotherapy: Healthy
Healthy participants received dose-matched placebo to MK-8189 monotherapy on Days 1-14
Units
Counts
Participants
OG0000
OG0011
OG0020
OG003
Title
Denominators
Categories
Title
Measurements
OG0019.14± NAMeasure of dispersion could not be estimated due to low number of participants analyzed
OG0038.38± 37.8
OG0088.86± 37.4
Primary
Number of Participants Experiencing an Adverse Event (AE)
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The number of participants who experienced at least one AE were reported.
All participants who received as least one dose of the investigational drug. Per protocol, safety was assessed by part and dose.
Posted
Number
Participants
Up to Day 28
ID
Title
Description
OG000
Part 1 Panel A & B MK-8189 Monotherapy 2 mg: Schizophrenic
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
OG001
Part 1 Panel A & B MK-8189 Monotherapy 4 mg: Schizophrenic
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 4 mg QD starting on Day 5 and continuing up to Day 14, based on participant tolerability
OG002
Part 1 Panel A & B MK-8189 Monotherapy 8 mg: Schizophrenic
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 8 mg QD starting on day 9 and continuing up to Day 11, based on participant tolerability
OG003
Part 1 Panel A & B MK-8189 Monotherapy 12 mg: Schizophrenic
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 12 mg QD starting on Day 12 and continuing up to Day 14, based on participant tolerability
OG004
Part 1 Panel A & B Placebo Monotherapy: Schizophrenic
Participants with Schizophrenia received dose-matched placebo to MK-8189 monotherapy on Days 1-14
OG005
Part 2 Panel C MK-8189 Add-on Therapy 2 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
OG006
Part 2 Panel C MK-8189 Add-on Therapy 4 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 4 mg QD starting on Day 1 and continuing up to Day 8, based on participant tolerability
OG007
Part 2 Panel C MK-8189 Add-on Therapy 8 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 8 mg QD starting on Day 5 and continuing up to Day 11, based on participant tolerability
OG008
Part 2 Panel C MK-8189 Add-on Therapy 12 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 12 mg QD starting on Day 9 and continuing up to Day 14, based on participant tolerability
OG009
Part 2 Panel C MK-8189 Add-on Therapy 16 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 16 mg QD starting on Day 12 and continuing up to day 14, based on participant tolerability
OG010
Part 2 Panel C Placebo Add-on Therapy: Schizophrenic
Participants with Schizophrenia received dose-matched placebo to MK-8189 add-on therapy on Days 1-14
OG011
Part 3 Panel D MK-8189 Monotherapy 2 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
OG012
Part 3 Panel D MK-8189 Monotherapy 4 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 4 mg QD starting on Day 5 and continuing up to Day 8, based on participant tolerability
OG013
Part 3 Panel D MK-8189 Monotherapy 8 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 8 mg QD starting on Day 9 and continuing up to Day 14, based on participant tolerability
OG014
Part 3 Panel D MK-8189 Monotherapy 12 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 12 mg QD starting on Day 12 and continuing up to Day 14, based on participant tolerability
OG015
Part 3 Panel D Placebo Monotherapy: Healthy
Healthy participants received dose-matched placebo to MK-8189 monotherapy on Days 1-14
Units
Counts
Participants
OG00014
OG00112
OG00210
OG003
Title
Denominators
Categories
Title
Measurements
OG0008
OG0016
OG0022
OG003
Primary
Number of Participants Who Discontinue From Study Treatment Due to an AE
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The number of participants who discontinued study treatment due to an AE were reported.
All participants who received as least one dose of the investigational drug. Per protocol, safety was assessed by part and dose.
Posted
Number
Participants
Up to Day 14
ID
Title
Description
OG000
Part 1 Panel A & B MK-8189 Monotherapy 2 mg: Schizophrenic
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
OG001
Part 1 Panel A & B MK-8189 Monotherapy 4 mg: Schizophrenic
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 4 mg QD starting on Day 5 and continuing up to Day 14, based on participant tolerability
OG002
Part 1 Panel A & B MK-8189 Monotherapy 8 mg: Schizophrenic
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 8 mg QD starting on day 9 and continuing up to Day 11, based on participant tolerability
OG003
Part 1 Panel A & B MK-8189 Monotherapy 12 mg: Schizophrenic
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 12 mg QD starting on Day 12 and continuing up to Day 14, based on participant tolerability
OG004
Part 1 Panel A & B Placebo Monotherapy: Schizophrenic
Participants with Schizophrenia received dose-matched placebo to MK-8189 monotherapy on Days 1-14
OG005
Part 2 Panel C MK-8189 Add-on Therapy 2 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
OG006
Part 2 Panel C MK-8189 Add-on Therapy 4 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 4 mg QD starting on Day 1 and continuing up to Day 8, based on participant tolerability
OG007
Part 2 Panel C MK-8189 Add-on Therapy 8 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 8 mg QD starting on Day 5 and continuing up to Day 11, based on participant tolerability
OG008
Part 2 Panel C MK-8189 Add-on Therapy 12 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 12 mg QD starting on Day 9 and continuing up to Day 14, based on participant tolerability
OG009
Part 2 Panel C MK-8189 Add-on Therapy 16 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 16 mg QD starting on Day 12 and continuing up to day 14, based on participant tolerability
OG010
Part 2 Panel C Placebo Add-on Therapy: Schizophrenic
Participants with Schizophrenia received dose-matched placebo to MK-8189 add-on therapy on Days 1-14
OG011
Part 3 Panel D MK-8189 Monotherapy 2 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
OG012
Part 3 Panel D MK-8189 Monotherapy 4 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 4 mg QD starting on Day 5 and continuing up to Day 8, based on participant tolerability
OG013
Part 3 Panel D MK-8189 Monotherapy 8 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 8 mg QD starting on Day 9 and continuing up to Day 14, based on participant tolerability
OG014
Part 3 Panel D MK-8189 Monotherapy 12 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 12 mg QD starting on Day 12 and continuing up to Day 14, based on participant tolerability
OG015
Part 3 Panel D Placebo Monotherapy: Healthy
Healthy participants received dose-matched placebo to MK-8189 monotherapy on Days 1-14
Units
Counts
Participants
OG00014
OG00112
OG00210
OG003
Title
Denominators
Categories
Title
Measurements
OG0001
OG0010
OG0020
OG003
Secondary
Change From Baseline at Day 13 in Mismatched Negativity (MMN) Peak Amplitude in Monotherapy MK-8189-treated Schizophrenia Participants
MMN is a response to deviant tone (stimuli) measured in electroencephalogram (EEG) signals. Difference in deviant EEG waveform amplitude from standard amplitude over time indicates MMN; this difference at peak waveform is MMN peak amplitude. Schizophrenic participants show reduced response to deviant stimuli. Peak amplitude change from baseline (Day -1) to Day 13 was reported. A higher change indicates improved response to deviant stimuli. Scalp EEG signals were collected using a standard system array of 19 electrodes denoted by nomenclature of scalp placement: C3, C4, Cz, F3, F4, F7, F8, Fp1, Fp2, Fz, O1, O2, P3, P4, Pz, T3, T4, T5, T6. As specified by the protocol, MK-8189 add-on therapy schizophrenia participants (Part 2), healthy participants (Part 3) and all placebo-treated participants were excluded from MMN analyses. Per protocol, MMN analyses were planned and executed in all schizophrenia participants receiving MK-8189 monotherapy, irrespective of different dosing schedules.
Per protocol, MMN analyses were planned and executed in all Schizophrenia participants receiving MK-8189 monotherapy (irrespective of dosing schedule) with EEG electrode data available. Per protocol MK-8189 add-on therapy schizophrenia participants (Part 2), healthy participants (Part 3) and all placebo-treated participants were excluded.
Posted
Mean
95% Confidence Interval
µV
Baseline and Day 13
ID
Title
Description
OG000
Part 1 Panel A & B MK-8189 Monotherapy 2-12 mg: Schizophrenic
Participants received MK-8189 escalating doses: 2 mg QD Days 1-4, 4 mg QD Days 5-8, 8 mg QD Days 9-11, and 12 mg QD Days 12-14 or alternatively 2 mg QD Days 1-4 and 4 mg QD Days 5-14
OG001
Part 1 Panel A & B Placebo Monotherapy: Schizophrenic
Participants with Schizophrenia received dose-matched placebo to MK-8189 monotherapy on Days 1-14
OG002
Part 2 Panel C MK-8189 Add-on Therapy 2-12 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy of MK-8189 in escalating doses: 2 mg QD Days 1-4, 4 mg QD Days 5-8, 8 mg QD Days 9-11, and 12 mg QD Days 12-14
OG003
Part 2 Panel C MK-8189 Add-on Therapy 4-16 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy of MK-8189 in escalating doses: 4 mg QD Days 1-4, 8 mg QD Days 5-8, 12 mg QD Days 9-11, and 16 mg QD Days 12-14
OG004
Part 2 Panel C Placebo Add-on Therapy: Schizophrenic
Participants with Schizophrenia received dose-matched placebo to MK-8189 add-on therapy on Days 1-14
OG005
Part 3 Panel D MK-8189 Monotherapy 2-12 mg: Healthy
Healthy participants received monotherapy of MK-8189 in escalating doses: 2 mg QD Days 1-4, 4 mg QD Days 5-8, 8 mg QD Days 9-11, and 12 mg QD Days 12-14
OG006
Part 3 Panel D MK-8189 Monotherapy 2-8 mg: Healthy
Healthy participant received monotherapy of MK-8189 in escalating doses: 2 mg QD Days 1-4, 4 mg QD Days 5-8, and 8 mg QD days 9-14
OG007
Part 3 Panel D Placebo Monotherapy: Healthy
Healthy participants received dose-matched placebo to MK-8189 monotherapy on Days 1-14
Units
Counts
Participants
OG00011
OG0010
OG0020
OG003
Title
Denominators
Categories
C3
Title
Measurements
OG0000.959(-0.218 to 2.137)
C4
Title
Measurements
OG0000.812(-0.169 to 1.794)
Cz
Secondary
Change From Baseline at Day 13 in Mismatched Negativity (MMN) Area Under Curve (AUC) in Monotherapy MK-8189-treated Schizophrenia Participants
MMN is a response to deviant tone (stimuli) measured in EEG signals. Difference in deviant EEG waveform amplitude from standard amplitude over time indicates MMN; AUC was measured as the product of MMN amplitude and time. Schizophrenic participants show reduced response to deviant stimuli. AUC change from baseline (Day -1) to Day 13 was reported. A higher change indicates improved response to deviant stimuli. Scalp EEG signals were collected using a standard system array of 19 electrodes denoted by nomenclature of scalp placement: C3, C4, Cz, F3, F4, F7, F8, Fp1, Fp2, Fz, O1, O2, P3, P4, Pz, T3, T4, T5, T6. As specified by the protocol, MK-8189 add-on therapy schizophrenia participants (Part 2), healthy participants (Part 3), and all placebo-treated participants were excluded from MMN analyses. Per protocol, MMN analyses were planned and executed in all schizophrenia participants receiving MK-8189 monotherapy, irrespective of different dosing schedules.
Per protocol, MMN analyses were planned and executed in all Schizophrenia participants receiving MK-8189 monotherapy (irrespective of dosing schedule) with EEG electrode data available. Per protocol, MK-8189 add-on therapy schizophrenia participants (Part 2), healthy participants (Part 3), and all placebo-treated participants were excluded.
Posted
Mean
95% Confidence Interval
µV*msec
Baseline and Day 13
ID
Title
Description
OG000
Part 1 Panel A & B MK-8189 Monotherapy 2-12 mg: Schizophrenic
Participants received MK-8189 escalating doses: 2 mg QD Days 1-4, 4 mg QD Days 5-8, 8 mg QD Days 9-11, and 12 mg QD Days 12-14 or alternatively 2 mg QD Days 1-4 and 4 mg QD Days 5-14
OG001
Part 1 Panel A & B Placebo Monotherapy: Schizophrenic
Participants with Schizophrenia received dose-matched placebo to MK-8189 monotherapy on Days 1-14
OG002
Part 2 Panel C MK-8189 Add-on Therapy 2-12 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy of MK-8189 in escalating doses: 2 mg QD Days 1-4, 4 mg QD Days 5-8, 8 mg QD Days 9-11, and 12 mg QD Days 12-14
OG003
Part 2 Panel C MK-8189 Add-on Therapy 4-16 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy of MK-8189 in escalating doses: 4 mg QD Days 1-4, 8 mg QD Days 5-8, 12 mg QD Days 9-11, and 16 mg QD Days 12-14
OG004
Part 2 Panel C Placebo Add-on Therapy: Schizophrenic
Participants with Schizophrenia received dose-matched placebo to MK-8189 add-on therapy on Days 1-14
OG005
Part 3 Panel D MK-8189 Monotherapy 2-12 mg: Healthy
Healthy participants received monotherapy of MK-8189 in escalating doses: 2 mg QD Days 1-4, 4 mg QD Days 5-8, 8 mg QD Days 9-11, and 12 mg QD Days 12-14
OG006
Part 3 Panel D MK-8189 Monotherapy 2-8 mg: Healthy
Healthy participant received monotherapy of MK-8189 in escalating doses: 2 mg QD Days 1-4, 4 mg QD Days 5-8, and 8 mg QD days 9-14
OG007
Part 3 Panel D Placebo Monotherapy: Healthy
Healthy participants received dose-matched placebo to MK-8189 monotherapy on Days 1-14
Units
Counts
Participants
OG00011
OG0010
OG0020
OG003
Title
Denominators
Categories
C3
Title
Measurements
OG000-4.162(-25.187 to 16.863)
C4
Title
Measurements
OG0002.800(-12.255 to 17.856)
Cz
0
14
0
14
8
14
EG001
Part 1 Panel A & B MK-8189 Monotherapy 4 mg: Schizophrenic
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 4 mg QD starting on Day 5 and continuing up to Day 14, based on participant tolerability
0
12
0
12
6
12
EG002
Part 1 Panel A & B MK-8189 Monotherapy 8 mg: Schizophrenic
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 8 mg QD starting on day 9 and continuing up to Day 11, based on participant tolerability
0
10
0
10
2
10
EG003
Part 1 Panel A & B MK-8189 Monotherapy 12 mg: Schizophrenic
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 12 mg QD starting on Day 12 and continuing up to Day 14, based on participant tolerability
0
10
0
10
6
10
EG004
Part 1 Panel A & B Placebo Monotherapy: Schizophrenic
Participants with Schizophrenia received dose-matched placebo to MK-8189 monotherapy on Days 1-14
0
4
0
4
3
4
EG005
Part 1 Panel A & B Post Study: Schizophrenic
Participants with Schizophrenia who received monotherapy MK-8189 or matching placebo during the treatment period, were followed for safety during the post study period
0
18
0
18
0
18
EG006
Part 2 Panel C MK-8189 Add-on Therapy 2 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
0
13
0
13
3
13
EG007
Part 2 Panel C MK-8189 Add-on Therapy 4 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 4 mg QD starting on Day 1 and continuing up to Day 8, based on participant tolerability
0
17
0
17
6
17
EG008
Part 2 Panel C MK-8189 Add-on Therapy 8 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 8 mg QD starting on Day 5 and continuing up to Day 11, based on participant tolerability
0
17
0
17
7
17
EG009
Part 2 Panel C MK-8189 Add-on Therapy 12 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 12 mg QD starting on Day 9 and continuing up to Day 14, based on participant tolerability
0
17
0
17
7
17
EG010
Part 2 Panel C MK-8189 Add-on Therapy 16 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 16 mg QD starting on Day 12 and continuing up to day 14, based on participant tolerability
0
6
0
6
2
6
EG011
Part 2 Panel C Placebo Add-on Therapy: Schizophrenic
Participants with Schizophrenia received dose-matched placebo to MK-8189 add-on therapy on Days 1-14
0
6
0
6
4
6
EG012
Part 2 Panel C Post Study: Schizophrenic
Participants with Schizophrenia who received add-on therapy MK-8189 or matching placebo during the treatment period, were followed for safety during the post study period
0
25
0
25
1
25
EG013
Part 3 Panel D MK-8189 Monotherapy 2 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
0
10
0
10
5
10
EG014
Part 3 Panel D MK-8189 Monotherapy 4 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 4 mg QD starting on Day 5 and continuing up to Day 8, based on participant tolerability
0
10
0
10
5
10
EG015
Part 3 Panel D MK-8189 Monotherapy 8 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 8 mg QD starting on Day 9 and continuing up to Day 14, based on participant tolerability
0
10
0
10
6
10
EG016
Part 3 Panel D MK-8189 Monotherapy 12 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 12 mg QD starting on Day 12 and continuing up to Day 14, based on participant tolerability
0
9
1
9
2
9
EG017
Part 3 Panel D Placebo Monotherapy: Healthy
Healthy participants received dose-matched placebo to MK-8189 monotherapy on Days 1-14
0
2
0
2
2
2
EG018
Part 1 Panel D Post Study: Healthy
Healthy participants who received monotherapy MK-8189 or matching placebo during the treatment period, were followed for safety during the post study period
0
12
0
12
0
12
EG0000 events0 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0140 events0 affected10 at risk
EG0150 events0 affected10 at risk
EG0161 events1 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
EG0000 events0 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0101 events1 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0140 events0 affected10 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Vertigo
Ear and labyrinth disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0141 events1 affected10 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Abdominal distension
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0042 events1 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0140 events0 affected10 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0100 events0 affected6 at risk
EG0111 events1 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0140 events0 affected10 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Constipation
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected18 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0140 events0 affected10 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0033 events3 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0081 events1 affected17 at risk
EG0093 events3 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0140 events0 affected10 at risk
EG0150 events0 affected10 at risk
EG0161 events1 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Dry mouth
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected18 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0140 events0 affected10 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Dyspepsia
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0140 events0 affected10 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Haemorrhoids
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0091 events1 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0140 events0 affected10 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Nausea
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected12 at risk
EG0022 events1 affected10 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0141 events1 affected10 at risk
EG0151 events1 affected10 at risk
EG0162 events2 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Salivary hypersecretion
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0141 events1 affected10 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Swollen tongue
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0140 events0 affected10 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Vomiting
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0031 events1 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0091 events1 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0140 events0 affected10 at risk
EG0150 events0 affected10 at risk
EG0161 events1 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Chest pain
General disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0121 events1 affected25 at risk
EG0130 events0 affected10 at risk
EG0141 events1 affected10 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Fatigue
General disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0140 events0 affected10 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Feeling hot
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0141 events1 affected10 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Feeling of body temperature change
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0142 events2 affected10 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Pyrexia
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0101 events1 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0140 events0 affected10 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Conjunctivitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0140 events0 affected10 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Gastroenteritis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0140 events0 affected10 at risk
EG0150 events0 affected10 at risk
EG0161 events1 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Hordeolum
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0100 events0 affected6 at risk
EG0111 events1 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0140 events0 affected10 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Rhinitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0081 events1 affected17 at risk
EG0090 events0 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0140 events0 affected10 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Urinary tract infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0031 events1 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0091 events1 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0140 events0 affected10 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Concussion
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0031 events1 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0140 events0 affected10 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Electrocardiogram QT prolonged
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected18 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0140 events0 affected10 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Decreased appetite
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0003 events3 affected14 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected10 at risk
EG0031 events1 affected10 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0101 events1 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0140 events0 affected10 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0081 events1 affected17 at risk
EG0090 events0 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0140 events0 affected10 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Costochondritis
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0140 events0 affected10 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0131 events1 affected10 at risk
EG0140 events0 affected10 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Muscle tightness
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected10 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0140 events0 affected10 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0031 events1 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0140 events0 affected10 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0031 events1 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0071 events1 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0140 events0 affected10 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Neck mass
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0140 events0 affected10 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0071 events1 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0140 events0 affected10 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Torticollis
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0101 events1 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0140 events0 affected10 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Akathisia
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected10 at risk
EG0031 events1 affected10 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0071 events1 affected17 at risk
EG0081 events1 affected17 at risk
EG0091 events1 affected17 at risk
EG0101 events1 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0141 events1 affected10 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Cognitive disorder
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0140 events0 affected10 at risk
EG0151 events1 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Disturbance in attention
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0140 events0 affected10 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Dizziness
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected14 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0101 events1 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0141 events1 affected10 at risk
EG0150 events0 affected10 at risk
EG0161 events1 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Dysarthria
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0101 events1 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0140 events0 affected10 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Dystonia
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected14 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0140 events0 affected10 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Head discomfort
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0131 events1 affected10 at risk
EG0140 events0 affected10 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Headache
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected12 at risk
EG0021 events1 affected10 at risk
EG0032 events1 affected10 at risk
EG0042 events1 affected4 at risk
EG0050 events0 affected18 at risk
EG0061 events1 affected13 at risk
EG0071 events1 affected17 at risk
EG0081 events1 affected17 at risk
EG0096 events5 affected17 at risk
EG0100 events0 affected6 at risk
EG0113 events3 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0141 events1 affected10 at risk
EG0153 events3 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Muscle contractions involuntary
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0140 events0 affected10 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Oromandibular dystonia
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0081 events1 affected17 at risk
EG0090 events0 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0140 events0 affected10 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Paraesthesia
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0141 events1 affected10 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Sleep paralysis
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0131 events1 affected10 at risk
EG0140 events0 affected10 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Somnolence
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0074 events4 affected17 at risk
EG0081 events1 affected17 at risk
EG0091 events1 affected17 at risk
EG0100 events0 affected6 at risk
EG0112 events2 affected6 at risk
EG0120 events0 affected25 at risk
EG0133 events3 affected10 at risk
EG0140 events0 affected10 at risk
EG0153 events3 affected10 at risk
EG0160 events0 affected9 at risk
EG0171 events1 affected2 at risk
EG0180 events0 affected12 at risk
Spasmodic dysphonia
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0031 events1 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0140 events0 affected10 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Tremor
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected18 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0101 events1 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0140 events0 affected10 at risk
EG0150 events0 affected10 at risk
EG0161 events1 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Abnormal dreams
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0140 events0 affected10 at risk
EG0151 events1 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Anhedonia
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0141 events1 affected10 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Anxiety
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0141 events1 affected10 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Depersonalisation
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0141 events1 affected10 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Derealisation
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0141 events1 affected10 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Insomnia
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected14 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0081 events1 affected17 at risk
EG0090 events0 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0141 events1 affected10 at risk
EG0152 events2 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Irritability
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0140 events0 affected10 at risk
EG0150 events0 affected10 at risk
EG0161 events1 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Psychotic disorder
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0100 events0 affected6 at risk
EG0111 events1 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0140 events0 affected10 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0140 events0 affected10 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Acne
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0140 events0 affected10 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0140 events0 affected10 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0002 events2 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0140 events0 affected10 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Rash
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0140 events0 affected10 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected9 at risk
EG0171 events1 affected2 at risk
EG0180 events0 affected12 at risk
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected10 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0140 events0 affected10 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Flushing
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0091 events1 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0140 events0 affected10 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Hot flush
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0140 events0 affected10 at risk
EG0150 events0 affected10 at risk
EG0161 events1 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Orthostatic hypertension
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0140 events0 affected10 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Orthostatic hypotension
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected17 at risk
EG0091 events1 affected17 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected25 at risk
EG0130 events0 affected10 at risk
EG0140 events0 affected10 at risk
EG0151 events1 affected10 at risk
EG0160 events0 affected9 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected12 at risk
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
3
BG0055
BG0067
BG0070
BG0082
BG00938
Participants
OG004
0
ParticipantsOG00511
ParticipantsOG0066
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
Title
Measurements
OG00081.1± 94.8
OG00580.9± 49.1
OG006242± 67.9
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG00611
ParticipantsOG0076
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
Title
Measurements
OG001183± 52.2
OG006174± 39.4
OG007419± 59.6
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG00711
ParticipantsOG0086
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
Title
Measurements
OG001148± NAMeasure of dispersion could not be estimated due to low number of participants analyzed
OG002387± 42.0
OG007321± 45.1
OG008563± 72.3
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG00811
ParticipantsOG0096
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
Title
Measurements
OG001149± NAMeasure of dispersion could not be estimated due to low number of participants analyzed
OG003459± 33.3
OG008517± 52.0
OG009655± 69.0
9
OG0040
OG00513
OG00611
OG00711
OG00811
OG0096
OG0100
OG0110
OG0120
OG0130
OG0140
OG0150
0
ParticipantsOG0040
ParticipantsOG00513
ParticipantsOG0066
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
Title
Measurements
OG0001090± 29.8
OG0051040± 27.3
OG0062600± 41.0
Day 4
ParticipantsOG00012
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG00511
ParticipantsOG0066
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
Title
Measurements
OG0002160± 69.6
OG0051810± 42.7
OG0065740± 57.8
Day 8
ParticipantsOG0000
ParticipantsOG00112
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG00611
ParticipantsOG0076
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
Title
Measurements
OG0014390± 54.4
OG0064300± 31.5
OG00710500± 58.7
Day 11
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG00210
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG00711
ParticipantsOG0086
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
Title
Measurements
OG0014720± NAMeasure of dispersion could not be estimated due to low number of participants analyzed
OG0029770± 40.8
OG0078540± 31.2
OG008
Day 14
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0039
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG00811
ParticipantsOG0096
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
Title
Measurements
OG0014100± NAMeasure of dispersion could not be estimated due to low number of participants analyzed
OG00312300± 27.0
OG00813200± 38.5
OG009
9
OG0040
OG00513
OG00611
OG00711
OG00811
OG0096
OG0100
OG0110
OG0120
OG0130
OG0140
OG0150
0
ParticipantsOG0040
ParticipantsOG00513
ParticipantsOG0066
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
Title
Measurements
OG00070.7± 29.9
OG00563.6± 27.5
OG006165± 39.9
Day 4
ParticipantsOG00012
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG00511
ParticipantsOG0066
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
Title
Measurements
OG000118± 60.7
OG00590.6± 41.7
OG006277± 59.7
Day 8
ParticipantsOG0000
ParticipantsOG00112
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG00611
ParticipantsOG0076
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
Title
Measurements
OG001212± 52.0
OG006210± 29.8
OG007518± 56.5
Day 11
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG00210
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG00711
ParticipantsOG0086
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
Title
Measurements
OG001285± NAMeasure of dispersion could not be estimated due to low number of participants analyzed
OG002472± 40.8
OG007409± 28.8
OG008
Day 14
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0039
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG00811
ParticipantsOG0096
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
Title
Measurements
OG001209± NAMeasure of dispersion could not be estimated due to low number of participants analyzed
OG003628± 28.5
OG008638± 34.8
OG009
9
OG0040
OG00513
OG00611
OG00711
OG00811
OG0096
OG0100
OG0110
OG0120
OG0130
OG0140
OG0150
0
ParticipantsOG0040
ParticipantsOG00513
ParticipantsOG0066
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
Title
Measurements
OG00020(12 to 23.83)
OG00523.83(10.10 to 25.27)
OG00623.83(16 to 23.83)
Day 4
ParticipantsOG00012
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG00511
ParticipantsOG0066
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
Title
Measurements
OG00010(0 to 23.87)
OG00523.83(6 to 23.92)
OG0068(0 to 23.83)
Day 8
ParticipantsOG0000
ParticipantsOG00112
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG00611
ParticipantsOG0076
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
Title
Measurements
OG00110(0 to 23.98)
OG00616(0 to 23.83)
OG0070(0 to 10)
Day 11
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG00210
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG00711
ParticipantsOG0086
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
Title
Measurements
OG00110(NA to NA)Measure of dispersion could not be estimated due to low number of participants analyzed
OG00210.03(10 to 23.83)
OG00716(0 to 23.83)
OG008
Day 14
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0039
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG00811
ParticipantsOG0096
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
Title
Measurements
OG00120(NA to NA)Measure of dispersion could not be estimated due to low number of participants analyzed