A Single Dose Study of the Safety, Pharmacokinetics and P... | NCT02549014 | Trialant
NCT02549014
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Oct 23, 2018Actual
Enrollment
16Actual
Phase
Phase 1
Conditions
Pharmacokinetics
Interventions
MK-1064
Placebo
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
NCT02549014
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
1064-001
Secondary IDs
Not provided
Brief Title
A Single Dose Study of the Safety, Pharmacokinetics and Pharmacodynamics of MK-1064 (MK-1064-001)
Official Title
A Single Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-1064
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Sep 2018
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
Jul 6, 2009Actual
Primary Completion Date
Sep 29, 2009Actual
Completion Date
Sep 29, 2009Actual
First Submitted Date
Sep 11, 2015
First Submission Date that Met QC Criteria
Sep 11, 2015
First Posted Date
Sep 14, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 30, 2015
Results First Submitted that Met QC Criteria
Dec 15, 2015
Results First Posted Date
Jan 21, 2016Estimated
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
Sep 24, 2018
Last Update Posted Date
Oct 23, 2018Actual
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
The purpose of this randomized, double-blind, placebo-controlled study is to evaluate the safety, pharmacokinetics and pharmacodynamics of rising, single oral doses MK-1064 in healthy, young, male participants. The primary pharmacokinetic hypothesis is that at least one dose of MK-1064 that is generally safe and well tolerated produces an average MK-1064 plasma concentration from 0 to 4 hours of ≥2.2 μM. Since this is an early Phase I assessment of MK-1064 in humans, the study protocol allows for modifications to the outlined dose, dosing regimen and/or clinical or laboratory procedures, if required to address study objectives and/or to ensure appropriate safety monitoring of participants.
Detailed Description
Two panels (Panels A and B), will receive alternating single rising oral doses of MK-1064/placebo (i.e., order of administration will be Panel A 5 mg, Panel B 10 mg, Panel A 25 mg, Panel B 50 mg, and continuing in this alternating sequence). Following dosing for a given treatment period, a minimum of 3 days will elapse before administration of the next scheduled dose. After administration of each dose, safety and tolerability will be reviewed. The decision to proceed to the next Panel/Period in the alternating sequence will be contingent on acceptable safety and tolerability data from the preceding Panels/Periods.
Conditions Module
Conditions
Pharmacokinetics
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
16Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Panel A: MK-1064 5 mg
Experimental
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
Drug: MK-1064
Panel B: MK-1064 10 mg
Experimental
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
Drug: MK-1064
Panel A: MK-1064 25 mg
Experimental
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
Drug: MK-1064
Panel B: MK-1064 50 mg
Experimental
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
Drug: MK-1064
Panel A: MK-1064 100 mg
Interventions
Name
Type
Description
Arm Group Labels
Other Names
MK-1064
Drug
Dose for each period administered as oral MK-1064 tablets (1, 10 and 50 mg strengths)
Panel A: MK-1064 100 mg
Panel A: MK-1064 200 mg
Panel A: MK-1064 25 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants Who Experienced One or More Adverse Events (AEs)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study drug, whether or not considered related to the use of study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of study drug, is also an AE.
Up to 14 days after the last dose of study drug (Up to approximately 60 days)
Number of Participants Who Discontinued Study Due to an AE
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study drug, whether or not considered related to the use of study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of study drug, is also an AE.
Up to 14 days after the last dose of study drug (Up to approximately 60 days)
Average Plasma Concentration From Time Zero to 4 Hours (Area Under the Plasma Drug Concentration-time Curve From Time Zero to 4 Hours [AUC0-4hr]) Following Single Doses of MK-1064
AUC0-4hr is the area under the plasma concentration-time curve from time 0 to 4 hours post-dose. This is a measure of the average amount of study drug (MK-1064) in the blood plasma over a period of 4 hours after the dose.
Pre-dose and 0.5, 1, 2, 3 and 4 hours post-dose
Secondary Outcomes
Measure
Description
Time Frame
Area Under the Plasma Drug Concentration-time Curve From Time Zero to Last Measurable Concentration (AUC0-last) Following Single Doses of MK-1064
AUC0-last is the area under the plasma concentration-time curve from time zero to time of last measurable concentration. It is is a measure of the amount of study drug (MK-1064) in the blood plasma from pre-dose until the last measurable concentration of study drug could be determined.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Body Mass Index (BMI) ≤31 kg/m^2
In good health based on medical history, physical examination, vital sign measurements, and laboratory safety tests
Nonsmoker and has not used nicotine or nicotine-containing products for at least approximately 6 months
Exclusion Criteria:
Mentally or legally incapacitated, significant emotional problems at screening or expected during the conduct of the study or history of a clinically significant psychiatric disorder within the last 10 years
History of any persistent sleep abnormality (including difficulty falling asleep, difficulty staying asleep) lasting for 3 months or more, or history of obstructive sleep apnea, restless legs syndrome, or narcolepsy of any duration
Participant has experienced poor quality sleep (including difficulty falling asleep, difficulty staying asleep) for at least 4 of 7 nights per week in the past 30 days prior to screening
Participant works a night shift and is not able to avoid night shift work a minimum of 1 week before each treatment period
Participant has traveled across 3 or more time zones (transmeridian travel) in the last 2 weeks prior to study
Unwilling or unable to consume a standard high fat breakfast
History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
History of seizures, epilepsy, stroke, peripheral neuropathy, or other clinically significant neurological disease or cognitive impairment
History of cancer
History of cataplexy
Participant is unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies, beginning approximately 2 weeks prior to administration of the initial dose of study drug and throughout the study
Participant consumes >3 servings of alcohol a day
Participant consumes >6 caffeine servings a day
Participant has had major surgery, donated or lost 1 unit of blood (approximately 500 mL) or participated in another investigational study within 4 weeks prior to screening
History of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
Is currently a regular user of any illicit drugs or has a history of drug (including alcohol) abuse within 2 years of screening
Healthy male participants aged 18-45 years (inclusive) were recruited for this study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Panel A: MK-1064
Panel A: Eight (8) participants were included in this panel. Within each of up to 5 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 and 2 participants were randomly assigned to receive single oral doses of matching placebo. MK-1064 was administered in rising single doses of 5, 25, 100 and 200 mg over Periods 1-4, in the morning with participants in a fasted condition. In Period 5, a single MK-1064 dose of 25 mg or placebo was administered to participants in the morning following a standard high-fat breakfast. Dosing periods alternated with Panel B. There was to be a minimum 7-day washout between treatment periods for any given participant.
FG001
Panel B: MK-1064
Panel B: Eight (8) participants were included in this panel. Within each of up to 5 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 and 2 participants were randomly assigned to receive single oral doses of matching placebo. MK-1064 was administered in rising single doses of 10, 50, 150 and 250 mg over Periods 1-4, in the morning with participants in fasted condition. In Period 5, a single MK-1064 dose of 50 mg or placebo was administered to participants in the evening after a 4-hour fast. Dosing periods alternated with Panel A. There was to be a minimum 7 day wash-out between treatment periods for any given participant.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG0008 subjects
FG0018 subjects
COMPLETED
FG0008 subjects
FG0018 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Panel A: MK-1064
Panel A: Eight (8) participants were included in this panel. Within each of up to 5 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 and 2 participants were randomly assigned to receive single oral doses of matching placebo. MK-1064 was administered in rising single doses of 5, 25, 100 and 200 mg over Periods 1-4, in the morning with participants in a fasted condition. In Period 5, a single MK-1064 dose of 25 mg or placebo was administered to participants in the morning following a standard high-fat breakfast. Dosing periods alternated with Panel B. There was to be a minimum 7-day washout between treatment periods for any given participant.
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, Categorical
Count of Participants
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
Number of Participants Who Experienced One or More Adverse Events (AEs)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study drug, whether or not considered related to the use of study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of study drug, is also an AE.
All participants who received ≥1 dose of study drug.
Posted
Number
Participants
Up to 14 days after the last dose of study drug (Up to approximately 60 days)
ID
Title
Description
OG000
Panel A: MK-1064 5 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
Adverse Events Module
Frequency Threshold
5
Time Frame
Up to 14 days after the last dose of study drug (Up to approximately 60 days)
Description
All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.
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
Panel A: MK-1064 5 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Head injury
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Sensation of block in ear
Ear and labyrinth disorders
MedDRA 12.0
Systematic Assessment
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
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
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
No data available
No data is available for this block.
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
Experimental
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
Drug: MK-1064
Panel B: MK-1064 150 mg
Experimental
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
Drug: MK-1064
Panel A: MK-1064 200 mg
Experimental
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
Drug: MK-1064
Panel B: MK-1064 250 mg
Experimental
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
Drug: MK-1064
Panel A: MK-1064 25 mg (Fed)
Experimental
In Period 5, participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast.
Drug: MK-1064
Panel B: MK-1064 50 mg (Night)
Experimental
In Period 5, participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast.
Drug: MK-1064
Panels A & B: Placebo
Placebo Comparator
Within each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant.
Drug: Placebo
Panel A: MK-1064 25 mg (Fed)
Panel A: MK-1064 5 mg
Panel B: MK-1064 10 mg
Panel B: MK-1064 150 mg
Panel B: MK-1064 250 mg
Panel B: MK-1064 50 mg
Panel B: MK-1064 50 mg (Night)
Placebo
Drug
Dose for each period administered as oral placebo tablets matching active MK-1064 tablets
Panels A & B: Placebo
Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post dose (all Periods); 72 hours post-dose (Periods 3 and 4 only)
Maximum Observed Plasma Concentration (Cmax) Following Single Doses of MK-1064
Cmax is the maximum (peak) concentration of study drug (MK-1064) observed in blood plasma.
Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post dose (all Periods); 72 hours post dose (Periods 3 and 4 only)
Time to Cmax (Tmax) Following Single Doses of MK-1064
Tmax is the amount of time to reach maximum (peak) plasma drug concentration following drug administration.
Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post dose (all Periods); 72 hours post dose (Periods 3 and 4 only)
Apparent Terminal Half-life (t1/2) Following Single Doses of MK-1064
t1/2 is the elimination half-life of study drug. t1/2 is the time it takes for half of the study drug (MK-1064) in the blood plama to dissipate.
Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post dose (all Periods); 72 hours post dose (Periods 3 and 4 only)
BG001
Panel B: MK-1064
Panel B: Eight (8) participants were included in this panel. Within each of up to 5 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 and 2 participants were randomly assigned to receive single oral doses of matching placebo. MK-1064 was administered in rising single doses of 10, 50, 150 and 250 mg over Periods 1-4, in the morning with participants in fasted condition. In Period 5, a single MK-1064 dose of 50 mg or placebo was administered to participants in the evening after a 4-hour fast. Dosing periods alternated with Panel A. There was to be a minimum 7 day wash-out between treatment periods for any given participant.
BG002
Total
Total of all reporting groups
8
BG0018
BG00216
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
Between 18 and 65 years
BG0008
BG0018
BG00216
>=65 years
BG0000
BG0010
BG0020
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0010
BG0020
Male
BG0008
BG0018
BG00216
OG001
Panel B: MK-1064 10 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG002
Panel A: MK-1064 25 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG003
Panel B: MK-1064 50 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG004
Panel A: MK-1064 100 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG005
Panel B: MK-1064 150 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG006
Panel A: MK-1064 200 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG007
Panel B: MK-1064 250 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG008
Panel A: MK-1064 25 mg (Fed)
In Period 5, 6 participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast.
OG009
Panel B: MK-1064 50 mg (Night)
In Period 5, 6 participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast.
OG010
Panels A & B: Placebo
Within each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0036
OG0046
OG0056
OG0066
OG0076
OG0086
OG0096
OG01016
Title
Denominators
Categories
Title
Measurements
OG0004
OG0015
OG0025
OG0035
OG0045
OG0055
OG0066
OG0076
OG0083
OG0093
OG0105
Primary
Number of Participants Who Discontinued Study Due to an AE
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study drug, whether or not considered related to the use of study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of study drug, is also an AE.
All participants who received ≥1 dose of study drug.
Posted
Number
Participants
Up to 14 days after the last dose of study drug (Up to approximately 60 days)
ID
Title
Description
OG000
Panel A: MK-1064 5 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG001
Panel B: MK-1064 10 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG002
Panel A: MK-1064 25 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG003
Panel B: MK-1064 50 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG004
Panel A: MK-1064 100 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG005
Panel B: MK-1064 150 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG006
Panel A: MK-1064 200 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG007
Panel B: MK-1064 250 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG008
Panel A: MK-1064 25 mg (Fed)
In Period 5, 6 participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast.
OG009
Panel B: MK-1064 50 mg (Night)
In Period 5, 6 participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast.
OG010
Panels A & B: Placebo
Within each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Average Plasma Concentration From Time Zero to 4 Hours (Area Under the Plasma Drug Concentration-time Curve From Time Zero to 4 Hours [AUC0-4hr]) Following Single Doses of MK-1064
AUC0-4hr is the area under the plasma concentration-time curve from time 0 to 4 hours post-dose. This is a measure of the average amount of study drug (MK-1064) in the blood plasma over a period of 4 hours after the dose.
All participants who received ≥1 dose of MK-1064.
Posted
Geometric Mean
Standard Deviation
µmol*hr/L
Pre-dose and 0.5, 1, 2, 3 and 4 hours post-dose
ID
Title
Description
OG000
Panel A: MK-1064 5 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG001
Panel B: MK-1064 10 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG002
Panel A: MK-1064 25 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG003
Panel B: MK-1064 50 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG004
Panel A: MK-1064 100 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG005
Panel B: MK-1064 150 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG006
Panel A: MK-1064 200 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG007
Panel B: MK-1064 250 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG008
Panel A: MK-1064 25 mg (Fed)
In Period 5, 6 participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast.
OG009
Panel B: MK-1064 50 mg (Night)
In Period 5, 6 participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast.
OG010
Panels A & B: Placebo
Within each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.77± 0.13
OG0011.01± 0.42
OG0022.99± 0.41
OG003
Secondary
Area Under the Plasma Drug Concentration-time Curve From Time Zero to Last Measurable Concentration (AUC0-last) Following Single Doses of MK-1064
AUC0-last is the area under the plasma concentration-time curve from time zero to time of last measurable concentration. It is is a measure of the amount of study drug (MK-1064) in the blood plasma from pre-dose until the last measurable concentration of study drug could be determined.
All participants who received ≥1 dose of MK-1064.
Posted
Geometric Mean
Standard Deviation
µmol*hr/L
Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post dose (all Periods); 72 hours post-dose (Periods 3 and 4 only)
ID
Title
Description
OG000
Panel A: MK-1064 5 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG001
Panel B: MK-1064 10 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG002
Panel A: MK-1064 25 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG003
Panel B: MK-1064 50 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG004
Panel A: MK-1064 100 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG005
Panel B: MK-1064 150 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG006
Panel A: MK-1064 200 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG007
Panel B: MK-1064 250 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG008
Panel A: MK-1064 25 mg (Fed)
In Period 5, 6 participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast.
OG009
Panel B: MK-1064 50 mg (Night)
In Period 5, 6 participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast.
OG010
Panels A & B: Placebo
Within each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.94± 0.25
OG0011.67± 0.52
OG0025.32± 0.71
OG003
Secondary
Maximum Observed Plasma Concentration (Cmax) Following Single Doses of MK-1064
Cmax is the maximum (peak) concentration of study drug (MK-1064) observed in blood plasma.
All participants who received ≥1 dose of MK-1064.
Posted
Geometric Mean
Standard Deviation
µmol/L
Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post dose (all Periods); 72 hours post dose (Periods 3 and 4 only)
ID
Title
Description
OG000
Panel A: MK-1064 5 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG001
Panel B: MK-1064 10 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG002
Panel A: MK-1064 25 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG003
Panel B: MK-1064 50 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG004
Panel A: MK-1064 100 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG005
Panel B: MK-1064 150 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG006
Panel A: MK-1064 200 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG007
Panel B: MK-1064 250 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG008
Panel A: MK-1064 25 mg (Fed)
In Period 5, 6 participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast.
OG009
Panel B: MK-1064 50 mg (Night)
In Period 5, 6 participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast.
OG010
Panels A & B: Placebo
Within each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.37± 0.07
OG0010.42± 0.16
OG0021.06± 0.22
OG003
Secondary
Time to Cmax (Tmax) Following Single Doses of MK-1064
Tmax is the amount of time to reach maximum (peak) plasma drug concentration following drug administration.
All participants who received ≥1 dose of MK-1064.
Posted
Median
Full Range
hr
Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post dose (all Periods); 72 hours post dose (Periods 3 and 4 only)
ID
Title
Description
OG000
Panel A: MK-1064 5 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG001
Panel B: MK-1064 10 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG002
Panel A: MK-1064 25 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG003
Panel B: MK-1064 50 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG004
Panel A: MK-1064 100 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG005
Panel B: MK-1064 150 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG006
Panel A: MK-1064 200 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG007
Panel B: MK-1064 250 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG008
Panel A: MK-1064 25 mg (Fed)
In Period 5, 6 participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast.
OG009
Panel B: MK-1064 50 mg (Night)
In Period 5, 6 participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast.
OG010
Panels A & B: Placebo
Within each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0001.0± 0.07(0.5 to 2.0)
OG0011.5± 0.16(0.5 to 2.0)
OG0021.5± 0.22(0.5 to 2.0)
Secondary
Apparent Terminal Half-life (t1/2) Following Single Doses of MK-1064
t1/2 is the elimination half-life of study drug. t1/2 is the time it takes for half of the study drug (MK-1064) in the blood plama to dissipate.
All participants who received ≥1 dose of MK-1064.
Posted
Geometric Mean
Standard Deviation
hr
Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post dose (all Periods); 72 hours post dose (Periods 3 and 4 only)
ID
Title
Description
OG000
Panel A: MK-1064 5 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG001
Panel B: MK-1064 10 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG002
Panel A: MK-1064 25 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG003
Panel B: MK-1064 50 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG004
Panel A: MK-1064 100 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG005
Panel B: MK-1064 150 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG006
Panel A: MK-1064 200 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG007
Panel B: MK-1064 250 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
OG008
Panel A: MK-1064 25 mg (Fed)
In Period 5, 6 participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast.
OG009
Panel B: MK-1064 50 mg (Night)
In Period 5, 6 participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast.
OG010
Panels A & B: Placebo
Within each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG000NA± NA(0.5 to 2.0)t1/2 estimates not available due to lack of data at terminal phase.
OG001NA± NA(0.5 to 2.0)t1/2 estimates not available due to lack of data at terminal phase.
OG002
0
6
4
6
EG001
Panel B: MK-1064 10 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
0
6
5
6
EG002
Panel A: MK-1064 25 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
0
6
5
6
EG003
Panel B: MK-1064 50 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
0
6
5
6
EG004
Panel A: MK-1064 100 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
0
6
5
6
EG005
Panel B: MK-1064 150 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
0
6
5
6
EG006
Panel A: MK-1064 200 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
0
6
6
6
EG007
Panel B: MK-1064 250 mg
Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
0
6
6
6
EG008
Panel A: MK-1064 25 mg (Fed)
In Period 5, 6 participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast.
1
6
3
6
EG009
Panel B: MK-1064 50 mg (Night)
In Period 5, 6 participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast.
0
6
3
6
EG010
Panels A & B: Placebo
Within each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant.
0
16
5
16
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0081 events1 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected16 at risk
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0081 events1 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected16 at risk
Vision blurred
Eye disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected16 at risk
Bloated feeling
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected16 at risk
Flatulence
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected16 at risk
Loose stools
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0101 events1 affected16 at risk
Toothache
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected16 at risk
Vomiting
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0101 events1 affected16 at risk
Flu-like symptoms
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected16 at risk
Tiredness
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected16 at risk
Common cold
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0032 events2 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0062 events2 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0101 events1 affected16 at risk
Fractured thumb
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0081 events1 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected16 at risk
Scalp laceration
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0081 events1 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected16 at risk
Thumb sprain
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0081 events1 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected16 at risk
Appetite lost
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected16 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0081 events1 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected16 at risk
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0081 events1 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected16 at risk
Pain in arm
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0042 events2 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected16 at risk
Painful L arm
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0081 events1 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected16 at risk
Dizziness postural
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected16 at risk
Drowsiness
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events2 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected16 at risk
Headache
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0014 events4 affected6 at risk
EG0020 events0 affected6 at risk
EG0031 events1 affected6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected6 at risk
EG0063 events3 affected6 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected6 at risk
EG0102 events2 affected16 at risk
Lightheadedness
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected16 at risk
Loss of consciousness
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0081 events1 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected16 at risk
Mental concentration difficulty
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected16 at risk
Somnolence
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0024 events4 affected6 at risk
EG0032 events2 affected6 at risk
EG0045 events5 affected6 at risk
EG0055 events5 affected6 at risk
EG0066 events6 affected6 at risk
EG0076 events6 affected6 at risk
EG0083 events3 affected6 at risk
EG0091 events1 affected6 at risk
EG0101 events1 affected16 at risk
Euphoric mood
Psychiatric disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected16 at risk
Spontaneous penile erection
Reproductive system and breast disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected16 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected16 at risk
Sore throat
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected6 at risk
EG0100 events0 affected16 at risk
Orthostatic hypotension
Vascular disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected16 at risk
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 60 days prior to submission for publication/presentation.
6
OG0046
OG0056
OG0066
OG0076
OG0086
OG0096
OG01016
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
6
OG0046
OG0056
OG0066
OG0076
OG0086
OG0096
OG0100
5.51
± 2.29
OG0049.75± 1.31
OG00510.28± 3.42
OG00620.12± 9.03
OG00722.70± 7.98
OG0081.61± 0.25
OG0095.16± 2.60
6
OG0046
OG0056
OG0066
OG0076
OG0086
OG0096
OG0100
9.89
± 3.80
OG00423.12± 6.23
OG00525.92± 6.03
OG00653.37± 13.78
OG00757.10± 21.98
OG0085.27± 1.13
OG0099.91± 4.32
6
OG0046
OG0056
OG0066
OG0076
OG0086
OG0096
OG0100
2.09
± 0.77
OG0043.60± 0.85
OG0053.83± 1.46
OG0066.78± 3.52
OG0078.28± 2.87
OG0080.80± 0.13
OG0091.99± 0.64
6
OG0046
OG0056
OG0066
OG0076
OG0086
OG0096
OG0100
OG0032.0± 0.77(1.0 to 2.0)
OG0042.0± 0.85(1.0 to 5.0)
OG0051.0± 1.46(0.5 to 5.0)
OG0062.0± 3.52(1.0 to 3.0)
OG0072.0± 2.87(0.5 to 2.0)
OG0085.0± 0.13(2.0 to 5.0)
OG0092.0± 0.64(1.0 to 5.0)
6
OG0046
OG0056
OG0066
OG0075
OG0086
OG0096
OG0100
NA
± NA
(0.5 to 2.0)
t1/2 estimates not available due to lack of data at terminal phase.
OG003NA± NA(1.0 to 2.0)t1/2 estimates not available due to lack of data at terminal phase.
OG00411.1± 5.0(1.0 to 5.0)
OG0056.8± 3.2(0.5 to 5.0)
OG0067.5± 1.6(1.0 to 3.0)
OG0078.6± 2.7(0.5 to 2.0)
OG008NA± NA(2.0 to 5.0)t1/2 estimates not available due to lack of data at terminal phase.
OG009NA± NA(1.0 to 5.0)t1/2 estimates not available due to lack of data at terminal phase.