Study to Evaluate Pharmacokinetics of Prototype Modified-... | NCT02236988 | Trialant
NCT02236988
Sponsor
Amgen
Status
Completed
Last Update Posted
Jun 1, 2021Actual
Enrollment
80Actual
Phase
Phase 1
Conditions
Healthy Volunteers
Interventions
Apremilast Immediate Release
Apremilast Modified Release 1
Apremilast Modified Release 2
Apremilast Modified Release 3
Apremilast Modified Release 4
Apremilast Modified Release 5
Apremilast Modified Release 6
Apremilast Modified Release 8
Apremilast Modified Release 9
Apremilast Modified Release 11
Apremilast Modified Release 12
Apremilast Modified Release 13
Apremilast Modified Release 14
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT02236988
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CC-10004-CP-027
Secondary IDs
Not provided
Brief Title
Study to Evaluate Pharmacokinetics of Prototype Modified-Release Formulations Of Apremilast in Healthy Men
Official Title
A Phase 1, Open-Label, Single Center Study to Evaluate the Pharmacokinetics of Prototype Modified-Release Formulations Of Apremilast (CC-10004) in Healthy Male Subjects
Acronym
Not provided
Organization
AmgenINDUSTRY
Status Module
Record Verification Date
Mar 2021
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
YesNCT03740516No longer available
Start Date
Jan 7, 2014Actual
Primary Completion Date
Sep 11, 2014Actual
Completion Date
Sep 11, 2014Actual
First Submitted Date
Sep 9, 2014
First Submission Date that Met QC Criteria
Sep 9, 2014
First Posted Date
Sep 11, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
May 5, 2021
Results First Submitted that Met QC Criteria
May 5, 2021
Results First Posted Date
Jun 1, 2021Actual
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
May 5, 2021
Last Update Posted Date
Jun 1, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AmgenINDUSTRY
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 study will assess up to 12 different oral formulations of apremilast to determine how much apremilast is absorbed by the body compared to a reference formulation.
Detailed Description
This will be a single-center, open-label, crossover, single modified-release-dose study in adult males to evaluate the pharmacokinetics (PK) of prototype modified-release (MR) formulations compared to the reference immediate-release (IR) apremilast formulation. Within 4 separate groups, participants will be randomly assigned to a treatment sequence. A total of up to 12 test MR formulations may be evaluated.
Group 1: A 4-sequence, 4-period design to compare three modified-release prototypes with the reference immediate-release formulation. A total of 16 participants will be enrolled to obtain at least 12 participants who complete all 4 periods.
Group 2: A 4-sequence, 4-period design to compare three MR prototypes with the reference IR formulation. Sixteen participants will be enrolled to obtain at least 12 participants who complete all four periods.
Group 3: A six-sequence, three-period design to compare two MR prototypes with the reference IR formulation. Eighteen participants will be enrolled to obtain at least 12 participants who complete all three periods.
Group 4: A 10-sequence, 5-period design to compare four MR prototypes with the reference IR formulation. Thirty participants will be enrolled to obtain at least 20 participants who complete all five periods.
Conditions Module
Conditions
Healthy Volunteers
Keywords
Apremilast
Healthy male subjects
Pharmacokinetics
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
80Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Group 1
Experimental
Participants received the following 4 treatments, given in 4 possible sequences (ADBC, BACD, CBDA, and DCAB) with 7 to 10 days between each treatment:
A) Two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation) B) A single oral dose 75 mg apremilast tablet prototype MR 1 C) A single oral dose 75 mg apremilast tablet prototype MR 2 D) A single oral dose 75 mg apremilast capsule prototype MR 3
Drug: Apremilast Immediate Release
Drug: Apremilast Modified Release 1
Drug: Apremilast Modified Release 2
Drug: Apremilast Modified Release 3
Group 2
Experimental
Participants received the following 4 treatments, given in 4 possible sequences (AGEF, EAFG, FEGA, and GFAE) with 7 to 10 days between each treatment:
A) Two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation) E) A single oral dose 75 mg apremilast capsule prototype MR 4 F) A single oral dose 75 mg apremilast capsule prototype MR 5 G) A single oral dose 75 mg apremilast capsule prototype MR 6
Drug: Apremilast Immediate Release
Drug: Apremilast Modified Release 4
Drug: Apremilast Modified Release 5
Drug: Apremilast Modified Release 6
Group 3
Experimental
Participants received the following 3 treatments, given in 6 possible sequences (AIJ, IJA, JAI, AJI, IAJ, or JIA) with 7 to 10 days between each treatment:
A) Two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation) I) A single oral dose 80 mg apremilast capsule prototype MR 8 J) A single oral dose 80 mg apremilast capsule prototype MR 9
Drug: Apremilast Immediate Release
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Apremilast Immediate Release
Drug
30 mg immediate release tablets
Group 1
Group 2
Group 3
Group 4
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Group 1: Observed Maximum Plasma Concentration (Cmax) of Apremilast
Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.
IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.
Group 1: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measured Time Point (AUC0-t) of Apremilast
Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.
IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.
Group 1: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of Apremilast
Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.
IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.
Group 1: Time to Observed Maximum Plasma Concentration (Tmax) of Apremilast
Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.
IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.
Secondary Outcomes
Measure
Description
Time Frame
Group 1: Number of Participants With Treatment-emergent Adverse Events
An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology.
A treatment-emergent AE (TEAE) was defined as any AE that occurred after dosing of the study drug.
A serious adverse event (SAE) is any AE occurring at any dose that:
Resulted in death;
Was life-threatening;
Required inpatient hospitalization or prolongation of existing hospitalization;
Resulted in persistent or significant disability/incapacity;
Was a congenital anomaly/birth defect;
Constituted an important medical event.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Subjects must satisfy ALL of the following criteria to be eligible for enrollment into the study:
Must understand and voluntarily sign a written informed consent form prior to any study-related procedures being performed.
Must be able to communicate with the investigator, understand and comply with the requirements of the study, and agree to adhere to restrictions and examination schedules.
Male subjects of any race between 18 to 55 years of age (inclusive), and in good health as determined by the Investigator.
Has a body mass index between 18 and 33 kg/m^2 (inclusive).
No clinically significant laboratory tests as determined by the investigator.
Must not have a fever, with systolic blood pressure: 90 to 140 mmHg and diastolic blood pressure: 60 to 90 mmHg, and pulse rate: 40 to 110 bpm (measurements taken while lying down).
Must have a normal or clinically acceptable 12-lead electrocardiogram (ECG).
Subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception (male latex condom or non-latex condom not made out of natural [animal] membrane [eg, polyurethane]) while on study medication, and for 28 days after the last dose of study medication.
Must agree to refrain from donating sperm, blood or plasma (other than for this study) while participating in this study and for at least 28 days after the last dose of study drug.
Exclusion Criteria:
The presence of ANY of the following will exclude any healthy subject from enrollment into the study:
History of any clinically significant and relevant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, allergic disease, drug allergies, or other major disorders.
Any condition which places the subject at unacceptable risk if he were to participate in the study, or confounds the ability to interpret data from the study.
Use of any prescribed systemic or topical medication within 30 days of the first dose administration, unless Sponsor agreement is obtained.
Use of any non-prescribed systemic or topical medication (including vitamin/mineral supplements, and herbal medicines) within 14 days of the first dose administration, unless Sponsor agreement is obtained.
Any surgical or medical condition possibly affecting drug absorption, distribution, metabolism and excretion, eg, bariatric procedure, colon resection, irritable bowel syndrome, Crohn's disease, etc. Subjects with cholecytectomy and appendectomy may be included.
Exposure to an investigational drug (new chemical entity) within 30 days prior to the first dose administration or 5 half-lives of that investigational drug, if known (whichever is longer).
Donated blood or plasma within 8 weeks before the first dose administration to a blood bank or blood donation center.
History of drug abuse (as defined by the current version of the Diagnostic and Statistical Manual (DSM) within 2 years before dosing, or a positive drug screen reflecting consumption of illicit drugs.
History of alcohol abuse (as defined by the current version of the DSM) within 2 years before dosing, or a positive alcohol screen.
Known to have serum hepatitis, or known to be a carrier of the hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody, or have a positive result to the test for human immunodeficiency virus (HIV) antibodies at Screening.
Accepts Healthy Volunteers
Yes
Sex
Male
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
55 Years
Standard Ages
Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
MD
Amgen
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Covance Clinical Research Unit Inc.
Madison
Wisconsin
53704-2526
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Types
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access Criteria
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
This was an open-label crossover study that consisted of 4 groups of participants and tested 12 different modified release (MR) formulations of apremilast versus the reference immediate release (IR) formulation. Within each group participants were randomized to a treatment sequence.
Recruitment Details
This study was conducted at a single study site in the United States from July 2013 to September 2014.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Group 1
Participants received the following 4 treatments, given in 4 possible sequences (ADBC, BACD, CBDA, and DCAB) with 7 to 10 days between each treatment:
A) Two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation) B) A single oral dose 75 mg apremilast tablet prototype MR 1 C) A single oral dose 75 mg apremilast tablet prototype MR 2 D) A single oral dose 75 mg apremilast capsule prototype MR 3
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
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
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
MeSH Terms
Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
Not provided
Primary Purpose
Other
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: Apremilast Modified Release 8
Drug: Apremilast Modified Release 9
Group 4
Experimental
Participants received the following 5 treatments, given in 10 possible sequences (ALOMN, LMANO, MNLOA, NOMAL, OANLM, NMOLA, ONAML, AOLNM, LAMON, or MLNAO) with 7 to 10 days between each treatment:
A) Two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation) L) A single oral dose 80 mg apremilast capsule prototype MR 11 M) A single oral dose 80 mg apremilast capsule prototype MR 12 N) A single oral dose 80 mg apremilast capsule prototype MR 13 O) A single oral dose 80 mg apremilast capsule prototype MR 14
Drug: Apremilast Immediate Release
Drug: Apremilast Modified Release 11
Drug: Apremilast Modified Release 12
Drug: Apremilast Modified Release 13
Drug: Apremilast Modified Release 14
Otezla
CC-10004
Apremilast Modified Release 1
Drug
75 mg oral tablet of prototype modified release (MR) 1
Group 1
Apremilast Modified Release 2
Drug
75 mg oral tablet of prototype MR 2
Group 1
Apremilast Modified Release 3
Drug
75 mg oral capsule of prototype MR 3
Group 1
Apremilast Modified Release 4
Drug
75 mg oral capsule of prototype MR 4
Group 2
Apremilast Modified Release 5
Drug
75 mg oral capsule of prototype MR 5
Group 2
Apremilast Modified Release 6
Drug
75 mg oral capsule of prototype MR 6
Group 2
Apremilast Modified Release 8
Drug
80 mg oral capsule of prototype MR 8
Group 3
Apremilast Modified Release 9
Drug
80 mg oral capsule of prototype MR 9
Group 3
Apremilast Modified Release 11
Drug
80 mg oral capsule of prototype MR 11
Group 4
Apremilast Modified Release 12
Drug
80 mg oral capsule of prototype MR 12
Group 4
Apremilast Modified Release 13
Drug
80 mg oral capsule of prototype MR 13
Group 4
Apremilast Modified Release 14
Drug
80 mg oral capsule of prototype MR 14
Group 4
Group 1: Half-life of Apremilast in Terminal Phase (T1/2)
Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.
IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.
Group 1: Apparent Total Plasma Clearance (CL/F) of Apremilast
Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.
IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.
Group 1: Apparent Total Volume of Distribution (Vz/F) of Apremilast
Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.
IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.
Group 1: Relative Bioavailability of Apremilast Test Formulations Relative to Reference Corrected by Dose
Relative bioavailability of each test formulation compared to the reference formulation corrected by dose, calculated as:
IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.
Group 4: Relative Bioavailability of Apremilast Test Formulations Relative to Reference
Relative bioavailability of each test formulation compared to the reference formulation corrected by dose, calculated as:
(AUC0-∞[test]) / (AUC0-∞[reference]) * 100%.
IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.
Adverse events were collected for 7 to 10 days after each treatment.
Group 2: Number of Participants With Treatment-emergent Adverse Events
An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology.
A treatment-emergent AE (TEAE) was defined as any AE that occurred after dosing of the study drug.
A serious adverse event (SAE) is any AE occurring at any dose that:
Resulted in death;
Was life-threatening;
Required inpatient hospitalization or prolongation of existing hospitalization;
Resulted in persistent or significant disability/incapacity;
Was a congenital anomaly/birth defect;
Constituted an important medical event.
Adverse events were collected for 7 to 10 days after each treatment.
Group 3: Number of Participants With Treatment-emergent Adverse Events
An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology.
A treatment-emergent AE (TEAE) was defined as any AE that occurred after dosing of the study drug.
A serious adverse event (SAE) is any AE occurring at any dose that:
Resulted in death;
Was life-threatening;
Required inpatient hospitalization or prolongation of existing hospitalization;
Resulted in persistent or significant disability/incapacity;
Was a congenital anomaly/birth defect;
Constituted an important medical event.
Adverse events were collected for 7 to 10 days after each treatment.
Group 4: Number of Participants With Treatment-emergent Adverse Events
An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology.
A treatment-emergent AE (TEAE) was defined as any AE that occurred after dosing of the study drug.
A serious adverse event (SAE) is any AE occurring at any dose that:
Resulted in death;
Was life-threatening;
Required inpatient hospitalization or prolongation of existing hospitalization;
Resulted in persistent or significant disability/incapacity;
Was a congenital anomaly/birth defect;
Constituted an important medical event.
Adverse events were collected for 7 to 10 days after each treatment.
FG001
Group 2
Participants received the following 4 treatments, given in 4 possible sequences (AGEF, EAFG, FEGA, and GFAE) with 7 to 10 days between each treatment:
A) Two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation) E) A single oral dose 75 mg apremilast capsule prototype MR 4 F) A single oral dose 75 mg apremilast capsule prototype MR 5 G) A single oral dose 75 mg apremilast capsule prototype MR 6
FG002
Group 3
Participants received the following 3 treatments, given in 6 possible sequences (AIJ, IJA, JAI, AJI, IAJ, or JIA) with 7 to 10 days between each treatment:
A) Two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation) I) A single oral dose 80 mg apremilast capsule prototype MR 8 J) A single oral dose 80 mg apremilast capsule prototype MR 9
FG003
Group 4
Participants received the following 5 treatments, given in 10 possible sequences (ALOMN, LMANO, MNLOA, NOMAL, OANLM, NMOLA, ONAML, AOLNM, LAMON, or MLNAO) with 7 to 10 days between each treatment:
A) Two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation) L) A single oral dose 80 mg apremilast capsule prototype MR 11 M) A single oral dose 80 mg apremilast capsule prototype MR 12 N) A single oral dose 80 mg apremilast capsule prototype MR 13 O) A single oral dose 80 mg apremilast capsule prototype MR 14
FG00016 subjects
FG00116 subjects
FG00218 subjects
FG00330 subjects
COMPLETED
FG00016 subjects
FG00116 subjects
FG00218 subjects
FG00327 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0033 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
Unable to Comply with Study Visits
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Group 1
Participants received the following 4 treatments, given in 4 possible sequences (ADBC, BACD, CBDA, and DCAB) with 7 to 10 days between each treatment:
A) Two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation) B) A single oral dose 75 mg apremilast tablet prototype MR 1 C) A single oral dose 75 mg apremilast tablet prototype MR 2 D) A single oral dose 75 mg apremilast capsule prototype MR 3
BG001
Group 2
Participants received the following 4 treatments, given in 4 possible sequences (AGEF, EAFG, FEGA, and GFAE) with 7 to 10 days between each treatment:
A) Two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation) E) A single oral dose 75 mg apremilast capsule prototype MR 4 F) A single oral dose 75 mg apremilast capsule prototype MR 5 G) A single oral dose 75 mg apremilast capsule prototype MR 6
BG002
Group 3
Participants received the following 3 treatments, given in 6 possible sequences (AIJ, IJA, JAI, AJI, IAJ, or JIA) with 7 to 10 days between each treatment:
A) Two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation) I) A single oral dose 80 mg apremilast capsule prototype MR 8 J) A single oral dose 80 mg apremilast capsule prototype MR 9
BG003
Group 4
Participants received the following 5 treatments, given in 10 possible sequences (ALOMN, LMANO, MNLOA, NOMAL, OANLM, NMOLA, ONAML, AOLNM, LAMON, or MLNAO) with 7 to 10 days between each treatment:
A) Two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation) L) A single oral dose 80 mg apremilast capsule prototype MR 11 M) A single oral dose 80 mg apremilast capsule prototype MR 12 N) A single oral dose 80 mg apremilast capsule prototype MR 13 O) A single oral dose 80 mg apremilast capsule prototype MR 14
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00016
BG00116
BG00218
BG00330
BG00480
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Full Range
years
Title
Denominators
Categories
Title
Measurements
BG00039.1(29 to 55)
BG00134.1(20 to 50)
BG00230.4(21 to 43)
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0010
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0012
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
White
BG00011
BG00112
BG002
Body Mass Index (BMI)
Mean
Full Range
kg/m^2
Title
Denominators
Categories
Title
Measurements
BG00026.82(22.5 to 31.6)
BG00125.56(21.7 to 29.1)
BG002
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
Group 1: Observed Maximum Plasma Concentration (Cmax) of Apremilast
Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.
The pharmacokinetic (PK) population included all participants who received at least one dose of apremilast and had evaluable PK profiles.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.
ID
Title
Description
OG000
Group 1: Apremilast Immediate Release
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
OG001
Group 1: Apremilast Modified Release 1
Participants received a single oral dose 75 mg apremilast tablet prototype MR 1.
OG002
Group 1: Apremilast Modified Release 2
Participants received a single oral dose 75 mg apremilast tablet prototype MR 2.
OG003
Group 1: Apremilast Modified Release 3
Participants received a single oral dose 75 mg apremilast capsule prototype MR 3.
Units
Counts
Participants
OG00016
OG00116
OG00216
OG003
Title
Denominators
Categories
Title
Measurements
OG000409.96± 34.9
OG001267.85± 56.4
OG002329.78± 52.2
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
To compare each test formulation with the reference formulation in each group, an analysis of variance (ANOVA) was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.
Ratio of Adjusted Geometric Means
65.3
2-Sided
90
55.0
77.6
Ratio of adjusted geometric means (Apremilast Modified Release 1 / Apremilast Immediate Release) expressed as a percentage.
Other
Secondary
Group 1: Number of Participants With Treatment-emergent Adverse Events
An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology.
A treatment-emergent AE (TEAE) was defined as any AE that occurred after dosing of the study drug.
A serious adverse event (SAE) is any AE occurring at any dose that:
Resulted in death;
Was life-threatening;
Required inpatient hospitalization or prolongation of existing hospitalization;
Resulted in persistent or significant disability/incapacity;
Was a congenital anomaly/birth defect;
Constituted an important medical event.
Participants who received at least one dose of apremilast.
Posted
Count of Participants
Participants
Adverse events were collected for 7 to 10 days after each treatment.
ID
Title
Description
OG000
Group 1: Apremilast Immediate Release
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
OG001
Group 1: Apremilast Modified Release 1
Participants received a single oral dose 75 mg apremilast tablet prototype MR 1.
Primary
Group 1: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measured Time Point (AUC0-t) of Apremilast
Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.
The PK population included all participants who received at least one dose of apremilast and had evaluable PK profiles.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*h/mL
IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.
ID
Title
Description
OG000
Group 1: Apremilast Immediate Release
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
OG001
Group 1: Apremilast Modified Release 1
Participants received a single oral dose 75 mg apremilast tablet prototype MR 1.
OG002
Group 1: Apremilast Modified Release 2
Participants received a single oral dose 75 mg apremilast tablet prototype MR 2.
Primary
Group 1: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of Apremilast
Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.
The PK population included all participants who received at least one dose of apremilast and had evaluable PK profiles.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*h/mL
IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.
ID
Title
Description
OG000
Group 1: Apremilast Immediate Release
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
OG001
Group 1: Apremilast Modified Release 1
Participants received a single oral dose 75 mg apremilast tablet prototype MR 1.
OG002
Group 1: Apremilast Modified Release 2
Participants received a single oral dose 75 mg apremilast tablet prototype MR 2.
Primary
Group 1: Time to Observed Maximum Plasma Concentration (Tmax) of Apremilast
Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.
The PK population included all participants who received at least one dose of apremilast and had evaluable PK profiles.
Posted
Median
Full Range
hours
IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.
ID
Title
Description
OG000
Group 1: Apremilast Immediate Release
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
OG001
Group 1: Apremilast Modified Release 1
Participants received a single oral dose 75 mg apremilast tablet prototype MR 1.
OG002
Group 1: Apremilast Modified Release 2
Participants received a single oral dose 75 mg apremilast tablet prototype MR 2.
OG003
Primary
Group 1: Half-life of Apremilast in Terminal Phase (T1/2)
Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.
The PK population included all participants who received at least one dose of apremilast and had evaluable PK profiles.
Posted
Geometric Mean
Geometric Coefficient of Variation
hours
IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.
ID
Title
Description
OG000
Group 1: Apremilast Immediate Release
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
OG001
Group 1: Apremilast Modified Release 1
Participants received a single oral dose 75 mg apremilast tablet prototype MR 1.
OG002
Group 1: Apremilast Modified Release 2
Participants received a single oral dose 75 mg apremilast tablet prototype MR 2.
OG003
Primary
Group 1: Apparent Total Plasma Clearance (CL/F) of Apremilast
Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.
The PK population included all participants who received at least one dose of apremilast and had evaluable PK profiles.
Posted
Geometric Mean
Geometric Coefficient of Variation
L/h
IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.
ID
Title
Description
OG000
Group 1: Apremilast Immediate Release
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
OG001
Group 1: Apremilast Modified Release 1
Participants received a single oral dose 75 mg apremilast tablet prototype MR 1.
OG002
Group 1: Apremilast Modified Release 2
Participants received a single oral dose 75 mg apremilast tablet prototype MR 2.
OG003
Primary
Group 1: Apparent Total Volume of Distribution (Vz/F) of Apremilast
Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.
The PK population included all participants who received at least one dose of apremilast and had evaluable PK profiles.
Posted
Geometric Mean
Geometric Coefficient of Variation
liters
IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.
ID
Title
Description
OG000
Group 1: Apremilast Immediate Release
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
OG001
Group 1: Apremilast Modified Release 1
Participants received a single oral dose 75 mg apremilast tablet prototype MR 1.
OG002
Group 1: Apremilast Modified Release 2
Participants received a single oral dose 75 mg apremilast tablet prototype MR 2.
OG003
Primary
Group 1: Relative Bioavailability of Apremilast Test Formulations Relative to Reference Corrected by Dose
Relative bioavailability of each test formulation compared to the reference formulation corrected by dose, calculated as:
The PK population included all participants who received at least one dose of apremilast and had evaluable PK profiles.
Posted
Geometric Mean
Geometric Coefficient of Variation
percent availability
IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.
ID
Title
Description
OG000
Group 4: Apremilast Modified Release 11
Participants received a single oral dose 80 mg apremilast capsule prototype MR 11.
OG001
Group 4: Apremilast Modified Release 12
Participants received a single oral dose 80 mg apremilast capsule prototype MR 12.
OG002
Group 4: Apremilast Modified Release 13
Participants received a single oral dose 80 mg apremilast capsule prototype MR 13.
Primary
Group 4: Relative Bioavailability of Apremilast Test Formulations Relative to Reference
Relative bioavailability of each test formulation compared to the reference formulation corrected by dose, calculated as:
(AUC0-∞[test]) / (AUC0-∞[reference]) * 100%.
The PK population included all participants who received at least one dose of apremilast and had evaluable PK profiles.
Posted
Geometric Mean
Geometric Coefficient of Variation
percent availability
IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.
ID
Title
Description
OG000
Group 4: Apremilast Modified Release 11
Participants received a single oral dose 80 mg apremilast capsule prototype MR 11.
OG001
Group 4: Apremilast Modified Release 12
Participants received a single oral dose 80 mg apremilast capsule prototype MR 12.
OG002
Group 4: Apremilast Modified Release 13
Participants received a single oral dose 80 mg apremilast capsule prototype MR 13.
Secondary
Group 2: Number of Participants With Treatment-emergent Adverse Events
An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology.
A treatment-emergent AE (TEAE) was defined as any AE that occurred after dosing of the study drug.
A serious adverse event (SAE) is any AE occurring at any dose that:
Resulted in death;
Was life-threatening;
Required inpatient hospitalization or prolongation of existing hospitalization;
Resulted in persistent or significant disability/incapacity;
Was a congenital anomaly/birth defect;
Constituted an important medical event.
Participants who received at least one dose of apremilast.
Posted
Count of Participants
Participants
Adverse events were collected for 7 to 10 days after each treatment.
ID
Title
Description
OG000
Group 2: Apremilast Immediate Release
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
OG001
Group 2: Apremilast Modified Release 4
Participants received a single oral dose 75 mg apremilast capsule prototype MR 4.
Secondary
Group 3: Number of Participants With Treatment-emergent Adverse Events
An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology.
A treatment-emergent AE (TEAE) was defined as any AE that occurred after dosing of the study drug.
A serious adverse event (SAE) is any AE occurring at any dose that:
Resulted in death;
Was life-threatening;
Required inpatient hospitalization or prolongation of existing hospitalization;
Resulted in persistent or significant disability/incapacity;
Was a congenital anomaly/birth defect;
Constituted an important medical event.
Participants who received at least one dose of apremilast.
Posted
Count of Participants
Participants
Adverse events were collected for 7 to 10 days after each treatment.
ID
Title
Description
OG000
Group 3: Apremilast Immediate Release
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
OG001
Group 3: Apremilast Modified Release 8
Participants received a single oral dose 80 mg apremilast capsule prototype MR 8.
Secondary
Group 4: Number of Participants With Treatment-emergent Adverse Events
An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology.
A treatment-emergent AE (TEAE) was defined as any AE that occurred after dosing of the study drug.
A serious adverse event (SAE) is any AE occurring at any dose that:
Resulted in death;
Was life-threatening;
Required inpatient hospitalization or prolongation of existing hospitalization;
Resulted in persistent or significant disability/incapacity;
Was a congenital anomaly/birth defect;
Constituted an important medical event.
Participants who received at least one dose of apremilast.
Posted
Count of Participants
Participants
Adverse events were collected for 7 to 10 days after each treatment.
ID
Title
Description
OG000
Group 4: Apremilast Immediate Release
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
OG001
Group 4: Apremilast Modified Release 11
Participants received a single oral dose 80 mg apremilast capsule prototype MR 11.
Time Frame
Adverse events were collected for 7 to 10 days after each treatment.
Description
Adverse events are reported for all participants who received at least one dose of apremilast.
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
Group 1: Apremilast Immediate Release
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
0
16
5
16
EG001
Group 1: Apremilast Modified Release 1
Participants received a single oral dose 75 mg apremilast tablet prototype MR 1.
0
16
4
16
EG002
Group 1: Apremilast Modified Release 2
Participants received a single oral dose 75 mg apremilast tablet prototype MR 2.
0
16
2
16
EG003
Group 1: Apremilast Modified Release 3
Participants received a single oral dose 75 mg apremilast capsule prototype MR 3.
0
16
1
16
EG004
Group 1 Total
Participants received the following 4 treatments, given in 4 possible sequences (ADBC, BACD, CBDA, and DCAB) with 7 to 10 days between each treatment:
A) Two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation) B) A single oral dose 75 mg apremilast tablet prototype MR 1 C) A single oral dose 75 mg apremilast tablet prototype MR 2 D) A single oral dose 75 mg apremilast capsule prototype MR 3.
0
16
8
16
EG005
Group 2: Apremilast Immediate Release
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
0
16
4
16
EG006
Group 2: Apremilast Modified Release 4
Participants received a single oral dose 75 mg apremilast capsule prototype MR 4.
0
16
4
16
EG007
Group 2: Apremilast Modified Release 5
Participants received a single oral dose 75 mg apremilast capsule prototype MR 5.
0
16
6
16
EG008
Group 2: Apremilast Modified Release 6
Participants received a single oral dose 75 mg apremilast capsule prototype MR 6.
0
16
5
16
EG009
Group 2 Total
Participants received the following 4 treatments, given in 4 possible sequences (AGEF, EAFG, FEGA, and GFAE) with 7 to 10 days between each treatment:
A) Two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation) E) A single oral dose 75 mg apremilast capsule prototype MR 4 F) A single oral dose 75 mg apremilast capsule prototype MR 5 G) A single oral dose 75 mg apremilast capsule prototype MR 6
0
16
8
16
EG010
Group 3: Apremilast Immediate Release
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
0
18
5
18
EG011
Group 3: Apremilast Modified Release 8
Participants received a single oral dose 80 mg apremilast capsule prototype MR 8.
0
18
3
18
EG012
Group 3: Apremilast Modified Release 9
Participants received a single oral dose 80 mg apremilast capsule prototype MR 9.
0
18
3
18
EG013
Group 3 Total
Participants received the following 3 treatments, given in 6 possible sequences (AIJ, IJA, JAI, AJI, IAJ, or JIA) with 7 to 10 days between each treatment:
A) Two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation) I) A single oral dose 80 mg apremilast capsule prototype MR 8 J) A single oral dose 80 mg apremilast capsule prototype MR 9
0
18
7
18
EG014
Group 4: Apremilast Immediate Release
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
0
29
12
29
EG015
Group 4: Apremilast Modified Release 11
Participants received a single oral dose 80 mg apremilast capsule prototype MR 11.
0
29
5
29
EG016
Group 4: Apremilast Modified Release 12
Participants received a single oral dose 80 mg apremilast capsule prototype MR 12.
0
28
7
28
EG017
Group 4: Apremilast Modified Release 13
Participants received a single oral dose 80 mg apremilast capsule prototype MR 13.
0
28
5
28
EG018
Group 4: Apremilast Modified Release 14
Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.
0
28
7
28
EG019
Group 4 Total
Participants received the following 5 treatments, given in 10 possible sequences (ALOMN, LMANO, MNLOA, NOMAL, OANLM, NMOLA, ONAML, AOLNM, LAMON, or MLNAO) with 7 to 10 days between each treatment:
A) Two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation) L) A single oral dose 80 mg apremilast capsule prototype MR 11 M) A single oral dose 80 mg apremilast capsule prototype MR 12 N) A single oral dose 80 mg apremilast capsule prototype MR 13 O) A single oral dose 80 mg apremilast capsule prototype MR 14
0
30
17
30
EG020
Overall Total
All participants who received any dose of apremilast during the study.
0
80
40
80
Serious Adverse Events
Not provided
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
CONJUNCTIVAL HYPERAEMIA
Eye disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG0030 affected16 at risk
EG0040 affected16 at risk
EG0050 affected16 at risk
EG0060 affected16 at risk
EG0070 affected16 at risk
EG0080 affected16 at risk
EG0090 affected16 at risk
EG0101 affected18 at risk
EG0110 affected18 at risk
EG0120 affected18 at risk
EG0131 affected18 at risk
EG0140 affected29 at risk
EG0150 affected29 at risk
EG0160 affected28 at risk
EG0170 affected28 at risk
EG0180 affected28 at risk
EG0190 affected30 at risk
EG0201 affected80 at risk
VISION BLURRED
Eye disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
ABDOMINAL DISCOMFORT
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
ABDOMINAL PAIN UPPER
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
CHANGE OF BOWEL HABIT
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
DRY MOUTH
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
HAEMORRHOIDS
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0002 affected16 at risk
EG0010 affected16 at risk
EG0021 affected16 at risk
EG003
FOLLICULITIS
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
GASTROENTERITIS
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
VIRAL UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
ARTHROPOD STING
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
LACERATION
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
PROCEDURAL COMPLICATION
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
PROCEDURAL PAIN
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
PROCEDURAL SITE REACTION
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 affected16 at risk
EG0011 affected16 at risk
EG0020 affected16 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
DIZZINESS
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
DYSGEUSIA
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0003 affected16 at risk
EG0011 affected16 at risk
EG0022 affected16 at risk
EG003
PRESYNCOPE
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
SYNCOPE
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
DRY THROAT
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
OROPHARYNGEAL PAIN
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
RHINORRHOEA
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 affected16 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
ERYTHEMA
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0001 affected16 at risk
EG0010 affected16 at risk
EG0020 affected16 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Point of Contact
Title
Organization
Phone
Extension
Email
Study Director
Amgen Inc.
866-572-6436
medinfo@amgen.com
ID
Term
C505730
apremilast
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
33.3
(20 to 55)
BG00434.0(20 to 55)
0
BG0030
BG0040
Male
BG00016
BG00116
BG00218
BG00330
BG00480
3
BG0032
BG0047
Not Hispanic or Latino
BG00016
BG00114
BG00215
BG00328
BG00473
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
16
BG00321
BG00460
Black or African American
BG0003
BG0013
BG0022
BG0035
BG00413
American Indian or Alaska Native
BG0001
BG0010
BG0020
BG0030
BG0041
Asian
BG0001
BG0011
BG0020
BG0033
BG0045
Other
BG0000
BG0010
BG0020
BG0031
BG0041
24.83
(20.2 to 31.2)
BG00325.15(20.3 to 32.4)
BG00425.49(20.2 to 32.4)
16
345.11
± 41.5
OG000
OG002
To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.
Ratio of Adjusted Geometric Means
80.4
2-Sided
90
67.8
95.5
Ratio of adjusted geometric means (Apremilast Modified Release 2 / Apremilast Immediate Release) expressed as a percentage.
Other
OG000
OG003
To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.
Ratio of Adjusted Geometric Means
84.2
2-Sided
90
70.9
99.9
Ratio of adjusted geometric means (Apremilast Modified Release 3 / Apremilast Immediate Release) expressed as a percentage.
Other
OG002
Group 1: Apremilast Modified Release 2
Participants received a single oral dose 75 mg apremilast tablet prototype MR 2.
OG003
Group 1: Apremilast Modified Release 3
Participants received a single oral dose 75 mg apremilast capsule prototype MR 3.
Units
Counts
Participants
OG00016
OG00116
OG00216
OG00316
Title
Denominators
Categories
Any treatment-emergent adverse event (TEAE)
Title
Measurements
OG0005
OG0014
OG0022
OG0031
TEAEs related to study drug
Title
Measurements
OG0004
OG0011
OG0022
OG003
Serious adverse events
Title
Measurements
OG0000
OG0010
OG0020
OG003
Serious adverse events related to study drug
Title
Measurements
OG0000
OG0010
OG0020
OG003
Discontinuations due to adverse events
Title
Measurements
OG0000
OG0010
OG0020
OG003
Deaths
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG003
Group 1: Apremilast Modified Release 3
Participants received a single oral dose 75 mg apremilast capsule prototype MR 3.
Units
Counts
Participants
OG00016
OG00116
OG00216
OG00316
Title
Denominators
Categories
Title
Measurements
OG0006918.49± 47.7
OG0014277.83± 88.2
OG0024925.69± 67.7
OG0035103.07± 54.3
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.
Ratio of Adjusted Geometric Means
61.8
2-Sided
90
51.7
73.9
Ratio of adjusted geometric means (Apremilast Modified Release 1 / Apremilast Immediate Release) expressed as a percentage.
Other
OG000
OG002
To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.
Ratio of Adjusted Geometric Means
71.2
2-Sided
90
59.6
85.1
Ratio of adjusted geometric means (Apremilast Modified Release 2 / Apremilast Immediate Release) expressed as a percentage.
Other
OG000
OG003
To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.
Ratio of Adjusted Geometric Means
73.8
2-Sided
90
61.7
88.2
Ratio of adjusted geometric means (Apremilast Modified Release 3 / Apremilast Immediate Release) expressed as a percentage.
Other
OG003
Group 1: Apremilast Modified Release 3
Participants received a single oral dose 75 mg apremilast capsule prototype MR 3.
Units
Counts
Participants
OG00016
OG00116
OG00216
OG00316
Title
Denominators
Categories
Title
Measurements
OG0006955.76± 47.9
OG0014330.66± 88.2
OG0024961.51± 67.8
OG0035147.83± 54.5
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.
Ratio of Adjusted Geometric Means
62.3
2-Sided
90
52.1
74.4
Ratio of adjusted geometric means (Apremilast Modified Release 1 / Apremilast Immediate Release) expressed as a percentage.
Other
OG000
OG002
To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.
Ratio of Adjusted Geometric Means
71.3
2-Sided
90
59.7
85.2
Ratio of adjusted geometric means (Apremilast Modified Release 2 / Apremilast Immediate Release) expressed as a percentage.
Other
OG000
OG003
To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.
Ratio of Adjusted Geometric Means
74.0
2-Sided
90
62.0
88.4
Ratio of adjusted geometric means (Apremilast Modified Release 3 / Apremilast Immediate Release) expressed as a percentage.
Other
Group 1: Apremilast Modified Release 3
Participants received a single oral dose 75 mg apremilast capsule prototype MR 3.
Units
Counts
Participants
OG00016
OG00116
OG00216
OG00316
Title
Denominators
Categories
Title
Measurements
OG0003.00(2.00 to 5.00)
OG0014.00(2.00 to 8.00)
OG0024.00(2.00 to 8.00)
OG0034.00(3.00 to 14.00)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.
Wilcoxon signed-rank test
0.0090
Median Difference
1.00
2-Sided
90
0.5
2.00
Median difference (Apremilast Modified Release 1 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.
Other
OG000
OG002
Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.
Wilcoxon signed-rank test
0.0073
Median Difference
1.26
2-Sided
90
0.50
3.00
Median difference (Apremilast Modified Release 2 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.
Other
OG000
OG003
Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.
Wilcoxon signed-rank test
<0.0001
Median Difference
2.00
2-Sided
90
1.00
3.00
Median difference (Apremilast Modified Release 3 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate
Other
Group 1: Apremilast Modified Release 3
Participants received a single oral dose 75 mg apremilast capsule prototype MR 3.
Units
Counts
Participants
OG00016
OG00116
OG00216
OG00316
Title
Denominators
Categories
Title
Measurements
OG0007.12± 23.3
OG0017.43± 21.7
OG0026.88± 22.0
OG0037.29± 21.8
Group 1: Apremilast Modified Release 3
Participants received a single oral dose 75 mg apremilast capsule prototype MR 3.
Units
Counts
Participants
OG00016
OG00116
OG00216
OG00316
Title
Denominators
Categories
Title
Measurements
OG0008.63± 47.9
OG00117.32± 88.2
OG00215.12± 67.8
OG00314.57± 54.5
Group 1: Apremilast Modified Release 3
Participants received a single oral dose 75 mg apremilast capsule prototype MR 3.
Units
Counts
Participants
OG00016
OG00116
OG00216
OG00316
Title
Denominators
Categories
Title
Measurements
OG00088.65± 32.5
OG001185.65± 64.7
OG002149.97± 53.5
OG003153.23± 34.8
Units
Counts
Participants
OG00016
OG00116
OG00216
Title
Denominators
Categories
Title
Measurements
OG00039.85± 53.7
OG00145.65± 47.0
OG00247.37± 22.9
Units
Counts
Participants
OG00016
OG00116
OG00216
Title
Denominators
Categories
Title
Measurements
OG00062.26± 53.7
OG00171.33± 47.0
OG00274.01± 22.9
OG003
Group 2: Apremilast Modified Release 6
Participants received a single oral dose 75 mg apremilast capsule prototype MR 6.
Units
Counts
Participants
OG00016
OG00116
OG00216
OG00316
Title
Denominators
Categories
Title
Measurements
OG000405.38± 30.2
OG001368.45± 37.2
OG002298.96± 34.1
OG003325.20± 35.1
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.
Ratio of Adjusted Geometric Means
90.9
2-Sided
90
81.8
101.1
Ratio of adjusted geometric means (Apremilast Modified Release 4 / Apremilast Immediate Release) expressed as a percentage.
Other
OG000
OG002
To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.
Ratio of Adjusted Geometric Means
73.7
2-Sided
90
66.3
82.0
Ratio of adjusted geometric means (Apremilast Modified Release 5 / Apremilast Immediate Release) expressed as a percentage.
Other
OG000
OG003
To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.
Ratio of Adjusted Geometric Means
80.2
2-Sided
90
72.2
89.2
Ratio of adjusted geometric means (Apremilast Modified Release 6 / Apremilast Immediate Release) expressed as a percentage.
Other
OG003
Group 2: Apremilast Modified Release 6
Participants received a single oral dose 75 mg apremilast capsule prototype MR 6.
Units
Counts
Participants
OG00016
OG00116
OG00216
OG00316
Title
Denominators
Categories
Title
Measurements
OG0006635.78± 35.9
OG0015634.92± 40.2
OG0024780.60± 39.3
OG0035177.46± 36.9
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.
Ratio of Adjusted Geometric Means
84.9
2-Sided
90
77.5
93.0
Ratio of adjusted geometric means (Apremilast Modified Release 4 / Apremilast Immediate Release) expressed as a percentage.
Other
OG000
OG002
To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.
Ratio of Adjusted Geometric Means
72.0
2-Sided
90
65.8
78.9
Ratio of adjusted geometric means (Apremilast Modified Release 5 / Apremilast Immediate Release) expressed as a percentage.
Other
OG000
OG003
To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.
Ratio of Adjusted Geometric Means
78.0
2-Sided
90
71.2
85.5
Ratio of adjusted geometric means (Apremilast Modified Release 6 / Apremilast Immediate Release) expressed as a percentage.
Other
OG003
Group 2: Apremilast Modified Release 6
Participants received a single oral dose 75 mg apremilast capsule prototype MR 6.
Units
Counts
Participants
OG00016
OG00116
OG00216
OG00316
Title
Denominators
Categories
Title
Measurements
OG0006669.26± 36.0
OG0015700.66± 40.1
OG0024843.46± 38.9
OG0035259.40± 35.9
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.
Ratio of Adjusted Geometric Means
85.5
2-Sided
90
78.1
93.6
Ratio of adjusted geometric means (Apremilast Modified Release 4 / Apremilast Immediate Release) expressed as a percentage.
Other
OG000
OG002
To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.
Ratio of Adjusted Geometric Means
72.6
2-Sided
90
66.3
79.5
Ratio of adjusted geometric means (Apremilast Modified Release 5 / Apremilast Immediate Release) expressed as a percentage.
Other
OG000
OG003
To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.
Ratio of Adjusted Geometric Means
78.9
2-Sided
90
72.0
86.4
Ratio of adjusted geometric means (Apremilast Modified Release 6 / Apremilast Immediate Release) expressed as a percentage.
Other
Group 2: Apremilast Modified Release 6
Participants received a single oral dose 75 mg apremilast capsule prototype MR 6.
Units
Counts
Participants
OG00016
OG00116
OG00216
OG00316
Title
Denominators
Categories
Title
Measurements
OG0002.00(1.00 to 3.00)
OG0014.00(3.00 to 8.00)
OG0023.00(2.00 to 6.00)
OG0034.00(2.00 to 6.00)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.
Wilcoxon signed-rank test
0.0002
Median Difference
2.00
2-Sided
90
1.00
3.00
Median difference (Apremilast Modified Release 4 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.
Other
OG000
OG002
Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.
Wilcoxon signed-rank test
0.0049
Median Difference
1.02
2-Sided
90
0.50
2.00
Median difference (Apremilast Modified Release 5 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.
Other
OG000
OG003
Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.
Wilcoxon signed-rank test
0.0010
Median Difference
1.50
2-Sided
90
1.00
2.00
Median difference (Apremilast Modified Release 6 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate
Other
Group 2: Apremilast Modified Release 6
Participants received a single oral dose 75 mg apremilast capsule prototype MR 6.
Units
Counts
Participants
OG00016
OG00116
OG00216
OG00316
Title
Denominators
Categories
Title
Measurements
OG0008.16± 26.3
OG0018.98± 22.9
OG0028.43± 28.9
OG0038.75± 29.6
Group 2: Apremilast Modified Release 6
Participants received a single oral dose 75 mg apremilast capsule prototype MR 6.
Units
Counts
Participants
OG00016
OG00116
OG00216
OG00316
Title
Denominators
Categories
Title
Measurements
OG0009.00± 36.0
OG00113.16± 40.1
OG00215.48± 38.9
OG00314.26± 35.9
Group 2: Apremilast Modified Release 6
Participants received a single oral dose 75 mg apremilast capsule prototype MR 6.
Units
Counts
Participants
OG00016
OG00116
OG00216
OG00316
Title
Denominators
Categories
Title
Measurements
OG000105.88± 35.3
OG001170.51± 34.0
OG002188.24± 37.5
OG003180.10± 48.3
Units
Counts
Participants
OG00016
OG00116
OG00216
Title
Denominators
Categories
Title
Measurements
OG00054.71± 26.0
OG00146.48± 23.5
OG00250.47± 13.2
Units
Counts
Participants
OG00016
OG00116
OG00216
Title
Denominators
Categories
Title
Measurements
OG00085.48± 26.0
OG00172.62± 23.5
OG00278.86± 13.2
Units
Counts
Participants
OG00018
OG00118
OG00218
Title
Denominators
Categories
Title
Measurements
OG000378.59± 31.6
OG001344.61± 28.7
OG002334.51± 33.6
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.
Ratio of Adjusted Geometric Means
91.0
2-Sided
90
80.4
103.0
Ratio of adjusted geometric means (Apremilast Modified Release 8 / Apremilast Immediate Release) expressed as a percentage.
Other
OG000
OG002
To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.
Ratio of Adjusted Geometric Means
88.4
2-Sided
90
78.1
100.0
Ratio of adjusted geometric means (Apremilast Modified Release 9 / Apremilast Immediate Release) expressed as a percentage.
Other
Units
Counts
Participants
OG00018
OG00118
OG00218
Title
Denominators
Categories
Title
Measurements
OG0005493.38± 33.7
OG0014427.56± 32.7
OG0024310.62± 35.0
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.
Ratio of Adjusted Geometric Means
80.6
2-Sided
90
73.8
88.0
Ratio of adjusted geometric means (Apremilast Modified Release 8 / Apremilast Immediate Release) expressed as a percentage.
Other
OG000
OG002
To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.
Ratio of Adjusted Geometric Means
78.5
2-Sided
90
71.9
85.7
Ratio of adjusted geometric means (Apremilast Modified Release 9 / Apremilast Immediate Release) expressed as a percentage.
Other
Units
Counts
Participants
OG00018
OG00118
OG00218
Title
Denominators
Categories
Title
Measurements
OG0005518.28± 33.8
OG0014477.63± 32.7
OG0024359.49± 35.0
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.
Ratio of Adjusted Geometric Means
81.1
2-Sided
90
74.3
88.6
Ratio of adjusted geometric means (Apremilast Modified Release 8 / Apremilast Immediate Release) expressed as a percentage.
Other
OG000
OG002
To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.
Ratio of Adjusted Geometric Means
79.0
2-Sided
90
72.3
86.3
Ratio of adjusted geometric means (Apremilast Modified Release 9 / Apremilast Immediate Release) expressed as a percentage.
Other
Units
Counts
Participants
OG00018
OG00118
OG00218
Title
Denominators
Categories
Title
Measurements
OG0003.00(2.00 to 5.03)
OG0014.00(2.00 to 6.00)
OG0024.00(2.00 to 6.00)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.
Wilcoxon signed-rank test
0.0374
Median Difference
0.98
2-Sided
90
0.02
1.50
Median difference (Apremilast Modified Release 8 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.
Other
OG000
OG002
Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.
Wilcoxon signed-rank test
0.1907
Median Difference
0.51
2-Sided
90
0.00
1.50
Median difference (Apremilast Modified Release 9 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.
Other
Units
Counts
Participants
OG00018
OG00118
OG00218
Title
Denominators
Categories
Title
Measurements
OG0006.45± 23.8
OG0016.58± 29.2
OG0027.05± 27.0
Units
Counts
Participants
OG00018
OG00118
OG00218
Title
Denominators
Categories
Title
Measurements
OG00010.87± 33.8
OG00117.87± 32.7
OG00218.35± 35.0
Units
Counts
Participants
OG00018
OG00118
OG00218
Title
Denominators
Categories
Title
Measurements
OG000101.23± 37.2
OG001169.71± 34.0
OG002186.69± 34.8
OG00018
OG00118
Title
Denominators
Categories
Title
Measurements
OG00045.64± 21.4
OG00144.44± 21.1
OG00018
OG00118
Title
Denominators
Categories
Title
Measurements
OG00081.14± 21.4
OG00179.00± 21.1
OG003
Group 4: Apremilast Modified Release 13
Participants received a single oral dose 80 mg apremilast capsule prototype MR 13.
OG004
Group 4: Apremilast Modified Release 14
Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.
Units
Counts
Participants
OG00029
OG00129
OG00228
OG00328
OG00428
Title
Denominators
Categories
Title
Measurements
OG000438.90± 29.1
OG001480.59± 24.9
OG002481.10± 29.3
OG003316.43± 48.5
OG004450.23± 32.5
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.
Ratio of Adjusted Geometric Means
109.4
2-Sided
90
98.6
121.3
Ratio of adjusted geometric means (Apremilast Modified Release 11 / Apremilast Immediate Release) expressed as a percentage.
Other
OG000
OG002
To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.
Ratio of Adjusted Geometric Means
107.2
2-Sided
90
96.4
119.2
Ratio of adjusted geometric means (Apremilast Modified Release 12 / Apremilast Immediate Release) expressed as a percentage.
Other
OG000
OG003
To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.
Ratio of Adjusted Geometric Means
72.7
2-Sided
90
65.5
80.8
Ratio of adjusted geometric means (Apremilast Modified Release 13 / Apremilast Immediate Release) expressed as a percentage.
Other
OG000
OG004
To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.
Ratio of Adjusted Geometric Means
103.5
2-Sided
90
93.1
114.9
Ratio of adjusted geometric means (Apremilast Modified Release 14 / Apremilast Immediate Release) expressed as a percentage.
Other
OG003
Group 4: Apremilast Modified Release 13
Participants received a single oral dose 80 mg apremilast capsule prototype MR 13.
OG004
Group 4: Apremilast Modified Release 14
Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.
Units
Counts
Participants
OG00029
OG00129
OG00228
OG00328
OG00428
Title
Denominators
Categories
Title
Measurements
OG0006976.02± 32.3
OG0015701.21± 34.1
OG0025811.24± 29.0
OG0034700.70± 40.2
OG0045324.80± 36.5
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.
Ratio of Adjusted Geometric Means
81.5
2-Sided
90
75.2
88.3
Ratio of adjusted geometric means (Apremilast Modified Release 11 / Apremilast Immediate Release) expressed as a percentage.
Other
OG000
OG002
To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.
Ratio of Adjusted Geometric Means
82.4
2-Sided
90
75.9
89.5
Ratio of adjusted geometric means (Apremilast Modified Release 12 / Apremilast Immediate Release) expressed as a percentage.
Other
OG000
OG003
To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.
Ratio of Adjusted Geometric Means
68.2
2-Sided
90
62.9
74.0
Ratio of adjusted geometric means (Apremilast Modified Release 13 / Apremilast Immediate Release) expressed as a percentage.
Other
OG000
OG004
To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.
Ratio of Adjusted Geometric Means
77.4
2-Sided
90
71.3
84.0
Ratio of adjusted geometric means (Apremilast Modified Release 14 / Apremilast Immediate Release) expressed as a percentage.
Other
OG003
Group 4: Apremilast Modified Release 13
Participants received a single oral dose 80 mg apremilast capsule prototype MR 13.
OG004
Group 4: Apremilast Modified Release 14
Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.
Units
Counts
Participants
OG00029
OG00129
OG00228
OG00328
OG00428
Title
Denominators
Categories
Title
Measurements
OG0007000.35± 32.2
OG0015747.12± 34.0
OG0025875.19± 28.6
OG0034753.79± 40.1
OG0045374.83± 36.8
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.
Ratio of Adjusted Geometric Means
81.9
2-Sided
90
75.6
88.6
Ratio of adjusted geometric means (Apremilast Modified Release 11 / Apremilast Immediate Release) expressed as a percentage.
Other
OG000
OG002
To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.
Ratio of Adjusted Geometric Means
83.0
2-Sided
90
76.5
90.1
Ratio of adjusted geometric means (Apremilast Modified Release 12 / Apremilast Immediate Release) expressed as a percentage.
Other
OG000
OG003
To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.
Ratio of Adjusted Geometric Means
68.8
2-Sided
90
63.4
74.5
Ratio of adjusted geometric means (Apremilast Modified Release 13 / Apremilast Immediate Release) expressed as a percentage.
Other
OG000
OG004
To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.
Ratio of Adjusted Geometric Means
77.8
2-Sided
90
71.8
84.4
Ratio of adjusted geometric means (Apremilast Modified Release 14 / Apremilast Immediate Release) expressed as a percentage.
Other
Group 4: Apremilast Modified Release 13
Participants received a single oral dose 80 mg apremilast capsule prototype MR 13.
OG004
Group 4: Apremilast Modified Release 14
Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.
Units
Counts
Participants
OG00029
OG00129
OG00228
OG00328
OG00428
Title
Denominators
Categories
Title
Measurements
OG0003.00(1.00 to 5.08)
OG0014.00(2.00 to 6.00)
OG0024.00(2.00 to 6.00)
OG0034.01(2.00 to 14.00)
OG0043.52(2.00 to 6.00)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.
Wilcoxon signed-rank test
0.0523
Median Difference
0.98
2-Sided
90
0.03
1.50
Median difference (Apremilast Modified Release 11 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.
Other
OG000
OG002
Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.
Wilcoxon signed-rank test
0.2598
Median Difference
0.50
2-Sided
90
0.00
1.00
Median difference (Apremilast Modified Release 12 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.
Other
OG000
OG003
Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.
Wilcoxon signed-rank test
0.0053
Median Difference
1.50
2-Sided
90
1.00
3.00
Median difference (Apremilast Modified Release 13 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.
Other
OG000
OG004
Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.
Wilcoxon signed-rank test
0.1093
Median Difference
0.50
2-Sided
90
0.00
1.00
Median difference (Apremilast Modified Release 14 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.
Other
Group 4: Apremilast Modified Release 13
Participants received a single oral dose 80 mg apremilast capsule prototype MR 13.
OG004
Group 4: Apremilast Modified Release 14
Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.
Units
Counts
Participants
OG00029
OG00129
OG00228
OG00328
OG00428
Title
Denominators
Categories
Title
Measurements
OG0006.25± 24.8
OG0017.40± 25.2
OG0027.51± 34.9
OG0037.09± 31.0
OG0047.13± 32.5
Group 4: Apremilast Modified Release 13
Participants received a single oral dose 80 mg apremilast capsule prototype MR 13.
OG004
Group 4: Apremilast Modified Release 14
Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.
Units
Counts
Participants
OG00029
OG00129
OG00228
OG00328
OG00428
Title
Denominators
Categories
Title
Measurements
OG0008.57± 32.2
OG00113.92± 34.0
OG00213.62± 28.6
OG00316.83± 40.1
OG00414.88± 36.8
Group 4: Apremilast Modified Release 13
Participants received a single oral dose 80 mg apremilast capsule prototype MR 13.
OG004
Group 4: Apremilast Modified Release 14
Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.
Units
Counts
Participants
OG00029
OG00129
OG00228
OG00328
OG00428
Title
Denominators
Categories
Title
Measurements
OG00077.30± 36.0
OG001148.66± 32.5
OG002147.59± 41.5
OG003172.16± 44.6
OG004153.18± 36.1
OG003
Group 4: Apremilast Modified Release 14
Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.
Units
Counts
Participants
OG00029
OG00127
OG00228
OG00328
Title
Denominators
Categories
Title
Measurements
OG00046.18± 22.3
OG00146.86± 27.7
OG00238.65± 34.0
OG00343.70± 26.9
OG003
Group 4: Apremilast Modified Release 14
Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.
Units
Counts
Participants
OG00029
OG00127
OG00228
OG00328
Title
Denominators
Categories
Title
Measurements
OG00082.10± 22.3
OG00183.31± 27.7
OG00268.71± 34.0
OG00377.68± 26.9
OG002
Group 2: Apremilast Modified Release 5
Participants received a single oral dose 75 mg apremilast capsule prototype MR 5.
OG003
Group 2: Apremilast Modified Release 6
Participants received a single oral dose 75 mg apremilast capsule prototype MR 6.
Units
Counts
Participants
OG00016
OG00116
OG00216
OG00316
Title
Denominators
Categories
Any treatment-emergent adverse event (TEAE)
Title
Measurements
OG0004
OG0014
OG0026
OG0035
TEAEs related to study drug
Title
Measurements
OG0004
OG0012
OG0025
OG003
Serious adverse events
Title
Measurements
OG0000
OG0010
OG0020
OG003
Serious adverse events related to study drug
Title
Measurements
OG0000
OG0010
OG0020
OG003
Discontinuations due to adverse events
Title
Measurements
OG0000
OG0010
OG0020
OG003
Deaths
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG002
Group 3: Apremilast Modified Release 9
Participants received a single oral dose 80 mg apremilast capsule prototype MR 9.
Units
Counts
Participants
OG00018
OG00118
OG00218
Title
Denominators
Categories
Any treatment-emergent adverse event (TEAE)
Title
Measurements
OG0005
OG0013
OG0023
TEAEs related to study drug
Title
Measurements
OG0001
OG0010
OG0022
Serious adverse events
Title
Measurements
OG0000
OG0010
OG0020
Serious adverse events related to study drug
Title
Measurements
OG0000
OG0010
OG0020
Discontinuations due to adverse events
Title
Measurements
OG0000
OG0010
OG0020
Deaths
Title
Measurements
OG0000
OG0010
OG0020
OG002
Group 4: Apremilast Modified Release 12
Participants received a single oral dose 80 mg apremilast capsule prototype MR 12.
OG003
Group 4: Apremilast Modified Release 13
Participants received a single oral dose 80 mg apremilast capsule prototype MR 13.
OG004
Group 4: Apremilast Modified Release 14
Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.