A Study to Evaluate the Pharmacokinetics (PK), Safety and... | NCT03482453 | Trialant
NCT03482453
Sponsor
Millennium Pharmaceuticals, Inc.
Status
Completed
Last Update Posted
Jan 29, 2020Actual
Enrollment
69Actual
Phase
Phase 1
Conditions
Healthy Volunteers
Interventions
TAK-788
Placebo
TAK-788
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT03482453
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
TAK-788-1001
Secondary IDs
ID
Type
Description
Link
U1111-1208-9582
Other Identifier
WHO
Brief Title
A Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability of TAK-788 Followed by Evaluation of the Effects of a Low-Fat Meal on TAK-788 PK and Evaluation of Relative Bioavailability of TAK-788 Capsules in Healthy Participants
Official Title
Phase 1, Randomized, Double-blind, Placebo-Controlled, Single Rising Dose Study to Evaluate Pharmacokinetics, Safety, and Tolerability of TAK-788 Followed by Open-Label, Crossover Evaluation of the Effects of a Low-Fat Meal on TAK-788 Pharmacokinetics and Evaluation of Relative Bioavailability of TAK-788 Capsules in Healthy Subjects
Acronym
Not provided
Organization
TakedaINDUSTRY
Status Module
Record Verification Date
Jan 2020
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Mar 28, 2018Actual
Primary Completion Date
Dec 22, 2018Actual
Completion Date
Jan 18, 2019Actual
First Submitted Date
Mar 23, 2018
First Submission Date that Met QC Criteria
Mar 23, 2018
First Posted Date
Mar 29, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Jan 16, 2020
Results First Submitted that Met QC Criteria
Jan 16, 2020
Results First Posted Date
Jan 29, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jan 16, 2020
Last Update Posted Date
Jan 29, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Millennium Pharmaceuticals, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to assess the safety, tolerability of TAK-788 and to identify a tolerable single oral dose of TAK-788 administered as a drug-in-capsule (DiC) formulation, to characterize the effects of a low-fat meal on the PK of the TAK-788 administered as DiC formulation and to evaluate the bioavailability of a test (Process B) DiC of TAK-788 relative to a reference (Process A) DiC of TAK-788 in healthy participants.
Detailed Description
The drug being tested in this study is called TAK-788. The study will assess the safety and tolerability of single oral dose of TAK-788, evaluate the effect of a low-fat meal on PK of TAK-788 and will assess the relative bioavailability of two DiCs of TAK-788.
The study will enroll approximately 69 participants. The study is designed to consist of 3 parts: Part 1- dose escalation phase, Part 2- low fat meal effect and Part 3 - relative bioavailability. The study population of Part 1 will consist of 40 participants enrolled into 5 cohorts. Each cohort will have 8 randomized participants with 6 receiving a single dose of TAK-788, and 2 receiving matching placebo under fasted conditions. In Cohorts 1 to 5, safety of single-dose TAK-788 will be evaluated. For Part 2, the effect of a low-fat meal on a single tolerable dose of TAK-788 will be determined following review of safety and tolerability data from the previous cohorts in Part 1. The study population of Part 2 will consist of 16 participants enrolled into 2 cohorts of different doses, where participants will be randomized to a cross-over sequence of:
TAK-788 Fed + TAK-788 Fasted
TAK-788 Fasted + TAK-788 Fed
The study population of Part 3 will consist of 13 participants enrolled into 1 cohort, where participants will be randomized to a cross-over sequence of:
TAK-788 DiC (reference) + TAK-788 DiC (test)
TAK-788 DiC (test) + TAK-788 DiC (reference) This single-center trial will be conducted in the United States. The overall time to participate in this study is approximately 7 months. Participants will be contacted by telephone 30 days after the last dose of study drug for a follow-up assessment.
Conditions Module
Conditions
Healthy Volunteers
Keywords
Drug Therapy
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
69Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part 1 Cohort 1: TAK-788
Experimental
TAK-788, capsule, orally or TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1.
Drug: TAK-788
Drug: Placebo
Part 1 Cohort 2: TAK-788
Experimental
TAK-788, capsule, orally or TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1 following review of safety data from Cohort 1.
Drug: TAK-788
Drug: Placebo
Part 1 Cohort 3: TAK-788
Experimental
TAK-788, capsule, orally or TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1 following review of safety data from Cohort 2.
Drug: TAK-788
Drug: Placebo
Part 1 Cohort 4: TAK-788
Experimental
TAK-788, capsule, orally or TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1 following review of safety data from Cohort 3.
Drug: TAK-788
Drug: Placebo
Part 1 Cohort 5: TAK-788
Experimental
TAK-788, capsule, orally or TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1 following review of safety data from Cohort 4.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
TAK-788
Drug
TAK-788 capsules.
Part 1 Cohort 1: TAK-788
Part 1 Cohort 2: TAK-788
Part 1 Cohort 3: TAK-788
Part 1 Cohort 4: TAK-788
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part 1: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
Baseline up to 30 days after the last dose of study drug (Day 31)
Part 1: Number of Participants With One or More Serious Adverse Events (SAEs)
Baseline up to 30 days after the last dose of study drug (Day 31)
Part 1: Number of Participants With Clinically Significant Abnormal Laboratory Values
Baseline up to 30 days after the last dose of study drug (Day 31)
Part 1: Number of Participants With Clinically Significant Abnormal Vital Signs
Baseline up to 30 days after the last dose of study drug (Day 31)
Part 2, Cmax: Maximum Observed Plasma Concentration for TAK-788
Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Part 3, Cmax: Maximum Observed Plasma Concentration for TAK-788
Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Part 2, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-788
Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Part 3, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-788
Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Part 2, AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for TAK-788
Secondary Outcomes
Measure
Description
Time Frame
Part 1, Cmax: Maximum Observed Plasma Concentration for TAK-788 and Its Active Metabolites AP32960 and AP32914
Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Part 1, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-788 and Its Active Metabolites AP32960 and AP32914
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Body weight of greater than or equal to (>=) 45 kilogram (kg) (women) or >=55 kg (men) and a body mass index of 18.0 to 30.0 kilogram per square meter (kg/m^2) at screening.
Nonsmoker (never smoked or greater than [>] 20 years from last occurrence of smoking).
Normal organ function including hepatic, renal, and bone marrow function.
Exclusion Criteria:
Manifestations of malabsorption due to prior gastro-intestinal (GI) surgery, GI disease, or for an unknown other reason that may alter the PK of TAK-788.
Pulmonary infection ongoing or within 30 days of informed consent.
Inability to undergo venipuncture and/or tolerate venous access.
Inability to tolerate multiple blood sampling.
Ongoing or active infection, including but not limited to, the requirement for intravenous (IV) antibiotics.
Accepts Healthy Volunteers
Yes
Sex
All
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
Medical Director
Millennium Pharmaceuticals, Inc.
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
PRA Health Sciences
Salt Lake City
Utah
84124
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Healthy participants were enrolled in this 3 parts study to receive: TAK-788 as a single rising dose of 20 milligram (mg), 40 mg, 80 mg, 120 mg, 160 mg in Part 1; TAK-788 in a 2-way cross-over design with or without a low-fat meal in Part B; or in a 2-way cross-over sequence to receive TAK-788 drug in capsule (DiC) A or B in Part 3.
Recruitment Details
Participants took part in the study at 1 investigative site in the United States from 28 March 2018 to 18 January 2019.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1: Pooled Placebo
TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1.
FG001
Part 1 Cohort 1: TAK-788 20 mg
TAK-788 20 mg, capsule, orally, once under fasted conditions on Day 1.
Periods
Title
Milestones
Reasons Not Completed
Part 1 (1 Day)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Nov 13, 2018
Jan 16, 2020
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
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Other
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantCare ProviderInvestigator
Drug: TAK-788
Drug: Placebo
Part 2: TAK-788 Fed + TAK-788 Fasted
Experimental
TAK-788, capsule, orally, once on Day 1 of Intervention Period 1 under fed conditions with low-fat meal (Treatment A), followed by at least 7 days washout period, further followed by TAK-788, capsule, orally, once on Day 1 of Intervention Period 2 under fasted conditions (Treatment B). TAK-788 dose will be determined based on review of safety and tolerability data from cohorts of Part 1.
Drug: TAK-788
Part 2: TAK-788 Fasted + TAK-788 Fed
Experimental
TAK-788, capsule, orally, once on Day 1 of Intervention Period 1 under fasted conditions (Treatment B), followed by at least 7 days washout period, further followed by TAK-788, capsule, orally, once on Day 1 of Intervention Period 2 under fed conditions with low-fat meal (Treatment A). TAK-788 dose will be determined based on review of safety and tolerability data from cohorts of Part 1.
Drug: TAK-788
Part 3: TAK-788 DiC (reference) + TAK-788 DiC (test)
Experimental
TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 1, followed by at least 7 days washout period, further followed by TAK-788 160 mg, DiC B (test), orally, under fasted condition, once on Day 1 of Intervention Period 2.
Drug: TAK-788
Part 3: TAK-788 DiC (test) + TAK-788 DiC (reference)
Experimental
TAK-788 160 mg, DiC B (test), orally, under fasted condition, once, on Day 1 of Intervention Period 1, followed by at least 7 days washout period, further followed by TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 2.
Drug: TAK-788
Part 1 Cohort 5: TAK-788
Part 2: TAK-788 Fasted + TAK-788 Fed
Part 2: TAK-788 Fed + TAK-788 Fasted
AP32788
Placebo
Drug
TAK-788 placebo-matching capsules.
Part 1 Cohort 1: TAK-788
Part 1 Cohort 2: TAK-788
Part 1 Cohort 3: TAK-788
Part 1 Cohort 4: TAK-788
Part 1 Cohort 5: TAK-788
TAK-788
Drug
TAK-788 DiC.
Part 3: TAK-788 DiC (reference) + TAK-788 DiC (test)
Part 3: TAK-788 DiC (test) + TAK-788 DiC (reference)
AP32788
Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Part 3, AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for TAK-788
Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Part 2, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-788
Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Part 3, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-788
Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Part 2, t1/2z: Terminal Disposition Phase Half-life (t1/2z) for TAK-788
Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Part 3, t1/2z: Terminal Disposition Phase Half-life (t1/2z) for TAK-788
Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Part 1, AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for TAK-788 and Its Active Metabolites, AP32960 and AP32914
Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Part 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-788 and Its Active Metabolites AP32960 and AP32914
Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Part 1, t1/2z: Terminal Disposition Phase Half-life (t1/2z) for TAK-788 and Its Active Metabolites AP32960 and AP32914
Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Parts 2 and 3: Number of Participants Reporting One or More TEAEs
Baseline up to 30 days after the last dose of study drug (Day 38) (end of Intervention Period 2)
Parts 2 and 3: Number of Participants With One or More SAEs
Baseline up to 30 days after the last dose of study drug (Day 38) (end of Intervention Period 2)
Parts 2 and 3: Number of Participants With Clinically Significant Abnormal Laboratory Values
Baseline up to 30 days after the last dose of study drug (Day 38) (end of Intervention Period 2)
Parts 2 and 3: Number of Participants With Clinically Significant Abnormal Vital Signs
Baseline up to 30 days after the last dose of study drug (Day 38) (end of Intervention Period 2)
FG002
Part 1 Cohort 2: TAK-788 40 mg
TAK-788 40 mg, capsule, orally, once under fasted conditions on Day 1.
FG003
Part 1 Cohort 3: TAK-788 80 mg
TAK-788 80 mg, capsule, orally, once under fasted conditions on Day 1.
FG004
Part 1 Cohort 4: TAK-788 120 mg
TAK-788 120 mg, capsule, orally, once under fasted conditions on Day 1.
FG005
Part 1 Cohort 5: TAK-788 160 mg
TAK-788 160 mg, capsule, orally, once under fasted conditions on Day 1.
TAK-788 120 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fed conditions with low-fat meal (Treatment A), followed by at least 7 days washout period, further followed by TAK-788, 120 mg, capsule, orally, once on Day 1 of Intervention Period 2 under fasted conditions (Treatment B).
TAK-788, 120 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fasted conditions (Treatment B), followed by at least 7 days washout period, further followed by TAK-788, 120 mg, capsule, orally, once on Day 1 of Intervention Period 2 under fed conditions with low-fat meal (Treatment A).
TAK-788 160 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fed conditions with low-fat meal (Treatment A), followed by at least 7 days washout period, further followed by TAK-788 160 mg, capsule, orally, once on Day 1 of Intervention Period 2 under fasted conditions (Treatment B).
TAK-788, 160 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fasted conditions (Treatment B), followed by at least 7 days washout period, further followed by TAK-788, 160 mg, capsule, orally, once on Day 1 of Intervention Period 2 under fed conditions with low-fat meal (Treatment A).
FG010
Part 3: TAK-788 DiC A + TAK-788 DiC B
TAK-7 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 1, followed by at least 7 days washout period, further followed by TAK-788 160 mg, DiC B (test), orally, under fasted condition, once on Day 1 of Intervention Period 2.
FG011
Part 3: TAK-788 DiC B + TAK-788 DiC A
TAK-788 160 mg, DiC B (test), orally, under fasted condition, once on Day 1 of Intervention Period 1, followed by at least 7 days washout period, further followed by TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 2.
FG00010 subjects
FG0016 subjects
FG0026 subjects
FG0036 subjects
FG0046 subjects
FG0056 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
COMPLETED
FG00010 subjects
FG0016 subjects
FG0026 subjects
FG0036 subjects
FG0046 subjects
FG0056 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
Parts 2, 3 Intervention Period 1 (1 Day)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0063 subjects
FG0073 subjects
FG0085 subjects
FG0095 subjects
FG0107 subjects
FG0116 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Parts 2, 3 Washout Period (7 Days)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0063 subjects
FG0073 subjects
FG0085 subjects
FG0095 subjects
FG0106 subjects
FG0116 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Parts 2, 3 Intervention Period 2 (1 Day)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0063 subjects
FG0073 subjects
FG0085 subjects
FG0095 subjects
FG0106 subjects
FG0116 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
The safety set included all participants who received any study treatment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1: Pooled Placebo
TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1.
BG001
Part 1 Cohort 1: TAK-788 20 mg
TAK-788 20 mg, capsule, orally, once under fasted conditions on Day 1.
BG002
Part 1 Cohort 2: TAK-788 40 mg
TAK-788 40 mg, capsule, orally, once under fasted conditions on Day 1.
BG003
Part 1 Cohort 3: TAK-788 80 mg
TAK-788 80 mg, capsule, orally, once under fasted conditions on Day 1.
BG004
Part 1 Cohort 4: TAK-788 120 mg
TAK-788 120 mg, capsule, orally, once under fasted conditions on Day 1.
BG005
Part 1 Cohort 5: TAK-788 160 mg
TAK-788 160 mg, capsule, orally, once under fasted conditions on Day 1.
TAK-788 120 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fed conditions with low-fat meal (Treatment A), followed by at least 7 days washout period, further followed by TAK-788, 120 mg, capsule, orally, once on Day 1 of Intervention Period 2 under fasted conditions (Treatment B).
TAK-788, 120 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fasted conditions (Treatment B), followed by at least 7 days washout period, further followed by TAK-788, 120 mg, capsule, orally, once on Day 1 of Intervention Period 2 under fed conditions with low-fat meal (Treatment A).
TAK-788 160 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fed conditions with low-fat meal (Treatment A), followed by at least 7 days washout period, further followed by TAK-788 160 mg, capsule, orally, once on Day 1 of Intervention Period 2 under fasted conditions (Treatment B).
TAK-788, 160 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fasted conditions (Treatment B), followed by at least 7 days washout period, further followed by TAK-788, 160 mg, capsule, orally, once on Day 1 of Intervention Period 2 under fed conditions with low-fat meal (Treatment A).
BG010
Part 3: TAK-788 DiC A + TAK-788 DiC B
TAK-7 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 1, followed by at least 7 days washout period, further followed by TAK-788 160 mg, DiC B (test), orally, under fasted condition, once on Day 1 of Intervention Period 2.
BG011
Part 3: TAK-788 DiC B + TAK-788 DiC A
TAK-788 160 mg, DiC B (test), orally, under fasted condition, once on Day 1 of Intervention Period 1, followed by at least 7 days washout period, further followed by TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 2.
BG012
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00010
BG0016
BG0026
BG0036
BG0046
BG0056
BG0063
BG0073
BG0085
BG0095
BG0107
BG0116
BG01269
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0003
BG0010
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG0011
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
United States
Title
Measurements
BG00010
BG0016
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
Part 1: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
The safety set included all participants who received any study treatment.
Posted
Count of Participants
Participants
Baseline up to 30 days after the last dose of study drug (Day 31)
ID
Title
Description
OG000
Part 1: Pooled Placebo
TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1.
OG001
Part 1 Cohort 1: TAK-788 20 mg
TAK-788 20 mg, capsule, orally, once under fasted conditions on Day 1.
OG002
Part 1 Cohort 2: TAK-788 40 mg
TAK-788 40 mg, capsule, orally, once under fasted conditions on Day 1.
OG003
Part 1 Cohort 3: TAK-788 80 mg
TAK-788 80 mg, capsule, orally, once under fasted conditions on Day 1.
OG004
Part 1 Cohort 4: TAK-788 120 mg
TAK-788 120 mg, capsule, orally, once under fasted conditions on Day 1.
OG005
Part 1 Cohort 5: TAK-788 160 mg
TAK-788 160 mg, capsule, orally, once under fasted conditions on Day 1.
Units
Counts
Participants
OG00010
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0002
OG0012
OG0023
OG003
Primary
Part 1: Number of Participants With One or More Serious Adverse Events (SAEs)
The safety set included all participants who received any study treatment.
Posted
Count of Participants
Participants
Baseline up to 30 days after the last dose of study drug (Day 31)
ID
Title
Description
OG000
Part 1: Pooled Placebo
TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1.
OG001
Part 1 Cohort 1: TAK-788 20 mg
TAK-788 20 mg, capsule, orally, once under fasted conditions on Day 1.
OG002
Part 1 Cohort 2: TAK-788 40 mg
TAK-788 40 mg, capsule, orally, once under fasted conditions on Day 1.
OG003
Part 1 Cohort 3: TAK-788 80 mg
TAK-788 80 mg, capsule, orally, once under fasted conditions on Day 1.
OG004
Part 1 Cohort 4: TAK-788 120 mg
Primary
Part 1: Number of Participants With Clinically Significant Abnormal Laboratory Values
The safety set included all participants who received any study treatment.
Posted
Count of Participants
Participants
Baseline up to 30 days after the last dose of study drug (Day 31)
ID
Title
Description
OG000
Part 1: Pooled Placebo
TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1.
OG001
Part 1 Cohort 1: TAK-788 20 mg
TAK-788 20 mg, capsule, orally, once under fasted conditions on Day 1.
OG002
Part 1 Cohort 2: TAK-788 40 mg
TAK-788 40 mg, capsule, orally, once under fasted conditions on Day 1.
OG003
Part 1 Cohort 3: TAK-788 80 mg
TAK-788 80 mg, capsule, orally, once under fasted conditions on Day 1.
OG004
Part 1 Cohort 4: TAK-788 120 mg
Primary
Part 1: Number of Participants With Clinically Significant Abnormal Vital Signs
The safety set included all participants who received any study treatment.
Posted
Count of Participants
Participants
Baseline up to 30 days after the last dose of study drug (Day 31)
ID
Title
Description
OG000
Part 1: Pooled Placebo
TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1.
OG001
Part 1 Cohort 1: TAK-788 20 mg
TAK-788 20 mg, capsule, orally, once under fasted conditions on Day 1.
OG002
Part 1 Cohort 2: TAK-788 40 mg
TAK-788 40 mg, capsule, orally, once under fasted conditions on Day 1.
OG003
Part 1 Cohort 3: TAK-788 80 mg
TAK-788 80 mg, capsule, orally, once under fasted conditions on Day 1.
OG004
Part 1 Cohort 4: TAK-788 120 mg
Primary
Part 2, Cmax: Maximum Observed Plasma Concentration for TAK-788
The pharmacokinetic (PK) set included all participants in the safety set who had no major protocol deviations that would have affected the PK analysis and who had sufficient data to calculate PK parameters.
Posted
Geometric Mean
Standard Deviation
nanogram per milliliter (ng/mL)
Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
ID
Title
Description
OG000
Part 2: TAK-788 120 mg Fed
TAK-788 120 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
OG001
Part 2: TAK-788 120 mg Fasted
TAK-788, 120 mg, capsule, orally, under fasted conditions (Treatment B), once on Day 1 of either Intervention Period 1 or 2.
OG002
Part 2: TAK-788 160 mg Fed
TAK-788, 160 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
OG003
Part 2: TAK-788 160 mg Fasted
TAK-788, 160 mg, capsule, orally, under fasted conditions (Treatment B), once on Day 1 of either Intervention Period 1 or 2.
Primary
Part 3, Cmax: Maximum Observed Plasma Concentration for TAK-788
The PK set included all participants in the safety set who had no major protocol deviations that would have affected the PK analysis and who had sufficient data to calculate PK parameters.
Posted
Geometric Mean
Standard Deviation
ng/mL
Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
ID
Title
Description
OG000
Part 3: TAK-788 DiC A
TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of either Intervention Period 1 or 2.
OG001
Part 3: TAK-788 DiC B
TAK-788 160 mg, DiC B (test), orally, under fasted condition, once on Day 1 of either Intervention Period 1 or 2.
Units
Counts
Participants
OG000
Primary
Part 2, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-788
The PK set included all participants in the safety set who had no major protocol deviations that would have affected the PK analysis and who had sufficient data to calculate PK parameters.
Posted
Median
Full Range
hour
Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
ID
Title
Description
OG000
Part 2: TAK-788 120 mg Fed
TAK-788 120 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
OG001
Part 2: TAK-788 120 mg Fasted
TAK-788, 120 mg, capsule, orally, under fasted conditions (Treatment B), once on Day 1 of either Intervention Period 1 or 2.
OG002
Part 2: TAK-788 160 mg Fed
TAK-788, 160 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
OG003
Part 2: TAK-788 160 mg Fasted
TAK-788, 160 mg, capsule, orally, under fasted conditions (Treatment B), once on Day 1 of either Intervention Period 1 or 2.
Primary
Part 3, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-788
The PK set included all participants in the safety set who had no major protocol deviations that would have affected the PK analysis and who had sufficient data to calculate PK parameters.
Posted
Median
Full Range
hour
Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
ID
Title
Description
OG000
Part 3: TAK-788 DiC A
TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of either Intervention Period 1 or 2.
OG001
Part 3: TAK-788 DiC B
TAK-788 160 mg, DiC B (test), orally, under fasted condition, once on Day 1 of either Intervention Period 1 or 2.
Units
Counts
Participants
OG000
Primary
Part 2, AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for TAK-788
The PK set included all participants in the safety set who had no major protocol deviations that would have affected the PK analysis and who had sufficient data to calculate PK parameters.
Posted
Geometric Mean
Standard Deviation
hour*nanogram per milliliter (h*ng/mL)
Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
ID
Title
Description
OG000
Part 2: TAK-788 120 mg Fed
TAK-788 120 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
OG001
Part 2: TAK-788 120 mg Fasted
TAK-788, 120 mg, capsule, orally, under fasted conditions (Treatment B), once on Day 1 of either Intervention Period 1 or 2.
OG002
Part 2: TAK-788 160 mg Fed
TAK-788, 160 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
OG003
Part 2: TAK-788 160 mg Fasted
Primary
Part 3, AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for TAK-788
The PK set included all participants in the safety set who had no major protocol deviations that would have affected the PK analysis and who had sufficient data to calculate PK parameters.
Posted
Geometric Mean
Standard Deviation
h*ng/mL
Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
ID
Title
Description
OG000
Part 3: TAK-788 DiC A
TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of either Intervention Period 1 or 2.
OG001
Part 3: TAK-788 DiC B
TAK-788 160 mg, DiC B (test), orally, under fasted condition, once on Day 1 of either Intervention Period 1 or 2.
Units
Counts
Participants
OG000
Primary
Part 2, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-788
The PK set included all participants in the safety set who had no major protocol deviations that would have affected the PK analysis and who had sufficient data to calculate PK parameters.
Posted
Geometric Mean
Standard Deviation
h*ng/mL
Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
ID
Title
Description
OG000
Part 2: TAK-788 120 mg Fed
TAK-788 120 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
OG001
Part 2: TAK-788 120 mg Fasted
TAK-788, 120 mg, capsule, orally, under fasted conditions (Treatment B), once on Day 1 of either Intervention Period 1 or 2.
OG002
Part 2: TAK-788 160 mg Fed
TAK-788, 160 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
OG003
Part 2: TAK-788 160 mg Fasted
TAK-788, 160 mg, capsule, orally, under fasted conditions (Treatment B), once on Day 1 of either Intervention Period 1 or 2.
Primary
Part 3, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-788
The PK set included all participants in the safety set who had no major protocol deviations that would have affected the PK analysis and who had sufficient data to calculate PK parameters.
Posted
Geometric Mean
Standard Deviation
h*ng/mL
Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
ID
Title
Description
OG000
Part 3: TAK-788 DiC A
TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of either Intervention Period 1 or 2.
OG001
Part 3: TAK-788 DiC B
TAK-788 160 mg, DiC B (test), orally, under fasted condition, once on Day 1 of either Intervention Period 1 or 2.
Units
Counts
Participants
OG000
Primary
Part 2, t1/2z: Terminal Disposition Phase Half-life (t1/2z) for TAK-788
The PK set included all participants in the safety set who had no major protocol deviations that would have affected the PK analysis and who had sufficient data to calculate PK parameters.
Posted
Geometric Mean
Standard Deviation
hour
Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
ID
Title
Description
OG000
Part 2: TAK-788 120 mg Fed
TAK-788 120 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
OG001
Part 2: TAK-788 120 mg Fasted
TAK-788, 120 mg, capsule, orally, under fasted conditions (Treatment B), once on Day 1 of either Intervention Period 1 or 2.
OG002
Part 2: TAK-788 160 mg Fed
TAK-788, 160 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
OG003
Part 2: TAK-788 160 mg Fasted
TAK-788, 160 mg, capsule, orally, under fasted conditions (Treatment B), once on Day 1 of either Intervention Period 1 or 2.
Primary
Part 3, t1/2z: Terminal Disposition Phase Half-life (t1/2z) for TAK-788
The PK set included all participants in the safety set who had no major protocol deviations that would have affected the PK analysis and who had sufficient data to calculate PK parameters.
Posted
Geometric Mean
Standard Deviation
hour
Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
ID
Title
Description
OG000
Part 3: TAK-788 DiC A
TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of either Intervention Period 1 or 2.
OG001
Part 3: TAK-788 DiC B
TAK-788 160 mg, DiC B (test), orally, under fasted condition, once on Day 1 of either Intervention Period 1 or 2.
Units
Counts
Participants
OG000
Secondary
Part 1, Cmax: Maximum Observed Plasma Concentration for TAK-788 and Its Active Metabolites AP32960 and AP32914
The PK set included all participants in the safety set who had no major protocol deviations that would have affected the PK analysis and who had sufficient data to calculate PK parameters.
Posted
Geometric Mean
Standard Deviation
ng/mL
Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
ID
Title
Description
OG000
Part 1 Cohort 1: TAK-788 20 mg
TAK-788 20 mg, capsule, orally, once under fasted conditions on Day 1.
OG001
Part 1 Cohort 2: TAK-788 40 mg
TAK-788 40 mg, capsule, orally, once under fasted conditions on Day 1.
OG002
Part 1 Cohort 3: TAK-788 80 mg
TAK-788 80 mg, capsule, orally, once under fasted conditions on Day 1.
OG003
Part 1 Cohort 4: TAK-788 120 mg
TAK-788 120 mg, capsule, orally, once under fasted conditions on Day 1.
OG004
Secondary
Part 1, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-788 and Its Active Metabolites AP32960 and AP32914
The PK set included all participants in the safety set who had no major protocol deviations that would have affected the PK analysis and who had sufficient data to calculate PK parameters.
Posted
Median
Full Range
hour
Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
ID
Title
Description
OG000
Part 1 Cohort 1: TAK-788 20 mg
TAK-788 20 mg, capsule, orally, once under fasted conditions on Day 1.
OG001
Part 1 Cohort 2: TAK-788 40 mg
TAK-788 40 mg, capsule, orally, once under fasted conditions on Day 1.
OG002
Part 1 Cohort 3: TAK-788 80 mg
TAK-788 80 mg, capsule, orally, once under fasted conditions on Day 1.
OG003
Part 1 Cohort 4: TAK-788 120 mg
TAK-788 120 mg, capsule, orally, once under fasted conditions on Day 1.
OG004
Secondary
Part 1, AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for TAK-788 and Its Active Metabolites, AP32960 and AP32914
The PK set included all participants in the safety set who had no major protocol deviations that would have affected the PK analysis and who had sufficient data to calculate PK parameters.
Posted
Geometric Mean
Standard Deviation
h*ng/mL
Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
ID
Title
Description
OG000
Part 1 Cohort 1: TAK-788 20 mg
TAK-788 20 mg, capsule, orally, once under fasted conditions on Day 1.
OG001
Part 1 Cohort 2: TAK-788 40 mg
TAK-788 40 mg, capsule, orally, once under fasted conditions on Day 1.
OG002
Part 1 Cohort 3: TAK-788 80 mg
TAK-788 80 mg, capsule, orally, once under fasted conditions on Day 1.
OG003
Part 1 Cohort 4: TAK-788 120 mg
TAK-788 120 mg, capsule, orally, once under fasted conditions on Day 1.
Secondary
Part 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-788 and Its Active Metabolites AP32960 and AP32914
The PK set included all participants in the safety set who had no major protocol deviations that would have affected the PK analysis and who had sufficient data to calculate PK parameters. The PK analysis population where data at specified time points were available.
Posted
Geometric Mean
Standard Deviation
h*ng/mL
Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
ID
Title
Description
OG000
Part 1 Cohort 1: TAK-788 20 mg
TAK-788 20 mg, capsule, orally, once under fasted conditions on Day 1.
OG001
Part 1 Cohort 2: TAK-788 40 mg
TAK-788 40 mg, capsule, orally, once under fasted conditions on Day 1.
OG002
Part 1 Cohort 3: TAK-788 80 mg
TAK-788 80 mg, capsule, orally, once under fasted conditions on Day 1.
OG003
Part 1 Cohort 4: TAK-788 120 mg
TAK-788 120 mg, capsule, orally, once under fasted conditions on Day 1.
Secondary
Part 1, t1/2z: Terminal Disposition Phase Half-life (t1/2z) for TAK-788 and Its Active Metabolites AP32960 and AP32914
The PK set included all participants in the safety set who had no major protocol deviations that would have affected the PK analysis and who had sufficient data to calculate PK parameters. The PK analysis population where data at specified time points were available.
Posted
Geometric Mean
Standard Deviation
hour
Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
ID
Title
Description
OG000
Part 1 Cohort 1: TAK-788 20 mg
TAK-788 20 mg, capsule, orally, once under fasted conditions on Day 1.
OG001
Part 1 Cohort 2: TAK-788 40 mg
TAK-788 40 mg, capsule, orally, once under fasted conditions on Day 1.
OG002
Part 1 Cohort 3: TAK-788 80 mg
TAK-788 80 mg, capsule, orally, once under fasted conditions on Day 1.
OG003
Part 1 Cohort 4: TAK-788 120 mg
TAK-788 120 mg, capsule, orally, once under fasted conditions on Day 1.
Secondary
Parts 2 and 3: Number of Participants Reporting One or More TEAEs
The safety set included all participants who received any study treatment.
Posted
Count of Participants
Participants
Baseline up to 30 days after the last dose of study drug (Day 38) (end of Intervention Period 2)
ID
Title
Description
OG000
Part 2: TAK-788 120 mg Fed
TAK-788 120 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
OG001
Part 2: TAK-788 120 mg Fasted
TAK-788, 120 mg, capsule, orally, under fasted conditions (Treatment B), once on Day 1 of either Intervention Period 1 or 2.
OG002
Part 2: TAK-788 160 mg Fed
TAK-788, 160 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
OG003
Part 2: TAK-788 160 mg Fasted
TAK-788, 160 mg, capsule, orally, under fasted conditions (Treatment B), once on Day 1 of either Intervention Period 1 or 2.
Secondary
Parts 2 and 3: Number of Participants With One or More SAEs
The safety set included all participants who received any study treatment.
Posted
Count of Participants
Participants
Baseline up to 30 days after the last dose of study drug (Day 38) (end of Intervention Period 2)
ID
Title
Description
OG000
Part 2: TAK-788 120 mg Fed
TAK-788 120 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
OG001
Part 2: TAK-788 120 mg Fasted
TAK-788, 120 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fasted conditions (Treatment B).
OG002
Part 2: TAK-788 160 mg Fed
TAK-788, 160 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
OG003
Part 2: TAK-788 160 mg Fasted
TAK-788, 160 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fasted conditions (Treatment B).
Secondary
Parts 2 and 3: Number of Participants With Clinically Significant Abnormal Laboratory Values
The safety set included all participants who received any study treatment.
Posted
Count of Participants
Participants
Baseline up to 30 days after the last dose of study drug (Day 38) (end of Intervention Period 2)
ID
Title
Description
OG000
Part 2: TAK-788 120 mg Fed
TAK-788 120 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
OG001
Part 2: TAK-788 120 mg Fasted
TAK-788, 120 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fasted conditions (Treatment B).
OG002
Part 2: TAK-788 160 mg
TAK-788, 160 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fed conditions with low-fat meal (Treatment A).
OG003
Part 2: TAK-788 160 mg Fasted
TAK-788, 160 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fasted conditions (Treatment B).
Secondary
Parts 2 and 3: Number of Participants With Clinically Significant Abnormal Vital Signs
The safety set included all participants who received any study treatment.
Posted
Count of Participants
Participants
Baseline up to 30 days after the last dose of study drug (Day 38) (end of Intervention Period 2)
ID
Title
Description
OG000
Part 2: TAK-788 120 mg Fed
TAK-788 120 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
OG001
Part 2: TAK-788 120 mg Fasted
TAK-788, 120 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fasted conditions (Treatment B).
OG002
Part 2: TAK-788 160 mg Fed
TAK-788, 160 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
OG003
Part 2: TAK-788 160 mg Fasted
TAK-788, 160 mg, capsule, orally, once on Day 1 of Intervention Period 1 under fasted conditions (Treatment B).
Time Frame
TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to Day 31 in Part 1; Day 38 in Parts 2 and 3 [end of intervention period 2]) after the last dose of study drug
Description
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part 1: Pooled Placebo
TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1.
0
10
0
10
2
10
EG001
Part 1 Cohort 1: TAK-788 20 mg
TAK-788 20 mg, capsule, orally, once under fasted conditions on Day 1.
0
6
0
6
2
6
EG002
Part 1 Cohort 2: TAK-788 40 mg
TAK-788 40 mg, capsule, orally, once under fasted conditions on Day 1.
0
6
0
6
3
6
EG003
Part 1 Cohort 3: TAK-788 80 mg
TAK-788 80 mg, capsule, orally, once under fasted conditions on Day 1.
0
6
0
6
4
6
EG004
Part 1 Cohort 4: TAK-788 120 mg
TAK-788 120 mg, capsule, orally, once under fasted conditions on Day 1.
0
6
0
6
3
6
EG005
Part 1 Cohort 5: TAK-788 160 mg
TAK-788 160 mg, capsule, orally, once under fasted conditions on Day 1.
0
6
0
6
5
6
EG006
Part 2: TAK-788 120 mg Fed
TAK-788 120 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
0
6
0
6
3
6
EG007
Part 2: TAK-788 120 mg Fasted
TAK-788, 120 mg, capsule, orally, under fasted conditions (Treatment B), once on Day 1 of either Intervention Period 1 or 2.
0
6
0
6
3
6
EG008
Part 2: TAK-788 160 mg Fed
TAK-788, 160 mg, capsule, orally, under fed conditions with low-fat meal (Treatment A), once on Day 1 of either Intervention Period 1 or 2.
0
10
0
10
7
10
EG009
Part 2: TAK-788 160 mg Fasted
TAK-788, 160 mg, capsule, orally, under fasted conditions (Treatment B), once on Day 1 of either Intervention Period 1 or 2.
0
10
0
10
5
10
EG010
Part 3: TAK-788 DiC A
TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of either Intervention Period 1 or 2.
0
13
0
13
4
13
EG011
Part 3: TAK-788 DiC B
TAK-788 160 mg, DiC B (test), orally, under fasted condition, once on Day 1 of either Intervention Period 1 or 2.
0
12
0
12
4
12
Serious Adverse Events
Not provided
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nausea
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0041 affected6 at risk
EG0053 affected6 at risk
EG0061 affected6 at risk
EG0070 affected6 at risk
EG0083 affected10 at risk
EG0094 affected10 at risk
EG0101 affected13 at risk
EG0110 affected12 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Injection site cellulitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Lipase increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Headache
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Irritability
Psychiatric disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Throat irritation
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Eye pain
Eye disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Faeces soft
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Chest discomfort
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Feeling hot
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Injection site phlebitis
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Pain
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Amylase increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Haematoma
Vascular disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Pyrexia
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Tinea pedis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Nasal dryness
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected6 at risk
EG0020 affected6 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
Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
TAK-788 120 mg, capsule, orally, once under fasted conditions on Day 1.
OG005
Part 1 Cohort 5: TAK-788 160 mg
TAK-788 160 mg, capsule, orally, once under fasted conditions on Day 1.
Units
Counts
Participants
OG00010
OG0016
OG0026
OG0036
OG0046
OG0056
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
TAK-788 120 mg, capsule, orally, once under fasted conditions on Day 1.
OG005
Part 1 Cohort 5: TAK-788 160 mg
TAK-788 160 mg, capsule, orally, once under fasted conditions on Day 1.
Units
Counts
Participants
OG00010
OG0016
OG0026
OG0036
OG0046
OG0056
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
TAK-788 120 mg, capsule, orally, once under fasted conditions on Day 1.
OG005
Part 1 Cohort 5: TAK-788 160 mg
TAK-788 160 mg, capsule, orally, once under fasted conditions on Day 1.
Units
Counts
Participants
OG00010
OG0016
OG0026
OG0036
OG0046
OG0056
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Units
Counts
Participants
OG0006
OG0016
OG00210
OG00310
Title
Denominators
Categories
Title
Measurements
OG00027.52± 11.423
OG00131.24± 16.682
OG00239.51± 17.179
OG00341.00± 21.917
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
Geometric LS Mean Ratio
0.8810
2-Sided
90
0.7108
1.0921
Equivalence
A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The least square means (LS means) for the log-transformed parameters were exponentiated to obtain the point estimates and 90 percent (%) Confidence Intervals (CIs) of the geometric LS mean ratio on the original scale.
OG002
OG003
Geometric LS Mean Ratio
0.9637
2-Sided
90
0.8361
1.1107
Equivalence
A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The LS means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs of the geometric LS mean ratio on the original scale.
12
OG00112
Title
Denominators
Categories
Title
Measurements
OG00044.77± 14.738
OG00141.71± 11.931
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
Geometric LS Mean Ratio
0.9317
2-Sided
90
0.8458
1.0263
Equivalence
A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The LS means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs of the geometric LS mean ratio on the original scale.
Units
Counts
Participants
OG0006
OG0016
OG00210
OG00310
Title
Denominators
Categories
Title
Measurements
OG0006.0(4 to 8)
OG0014.0(2 to 6)
OG0026.0(2 to 8)
OG0036.0(2 to 12)
12
OG00112
Title
Denominators
Categories
Title
Measurements
OG0006.0(2 to 8)
OG0015.0(2 to 8)
TAK-788, 160 mg, capsule, orally, under fasted conditions (Treatment B), once on Day 1 of either Intervention Period 1 or 2.
Units
Counts
Participants
OG0006
OG0016
OG00210
OG00310
Title
Denominators
Categories
Title
Measurements
OG000526.3± 272.72
OG001518.3± 300.84
OG002700.6± 295.10
OG003733.6± 461.41
12
OG00112
Title
Denominators
Categories
Title
Measurements
OG000706.1± 173.63
OG001677.9± 239.28
Units
Counts
Participants
OG0006
OG0016
OG00210
OG00310
Title
Denominators
Categories
Title
Measurements
OG000533.8± 272.07
OG001525.8± 301.84
OG002706.3± 294.61
OG003743.0± 462.07
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
Geometric LS Mean Ratio
1.0153
2-Sided
90
0.8977
1.1483
Equivalence
A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The LS means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs of the geometric LS mean ratio on the original scale.
OG002
OG003
Geometric LS Mean Ratio
0.9506
2-Sided
90
0.8740
1.0339
Equivalence
A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The LS means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs of the geometric LS mean ratio on the original scale.
12
OG00112
Title
Denominators
Categories
Title
Measurements
OG000738.8± 193.06
OG001709.5± 262.84
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
Geometric LS Mean Ratio
0.9603
2-Sided
90
0.8861
1.0408
Equivalence
A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The LS means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs of the geometric LS mean ratio on the original scale.
Units
Counts
Participants
OG0006
OG0016
OG00210
OG00310
Title
Denominators
Categories
Title
Measurements
OG00017.17± 2.629
OG00117.60± 4.067
OG00220.72± 4.827
OG00320.62± 6.854
12
OG00112
Title
Denominators
Categories
Title
Measurements
OG00016.38± 2.007
OG00116.38± 2.858
Part 1 Cohort 5: TAK-788 160 mg
TAK-788 160 mg, capsule, orally, once under fasted conditions on Day 1.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0036
OG0046
Title
Denominators
Categories
TAK-788
Title
Measurements
OG0003.22± 0.938
OG0017.85± 4.206
OG00214.66± 11.649
OG00325.81± 9.682
OG00452.21± 27.681
Metabolite AP32960
Title
Measurements
OG0001.546± 0.4914
OG0013.483± 0.8827
OG0028.298± 5.5055
OG003
Metabolite AP32914
Title
Measurements
OG000NA± NAData could not be derived since concentration values were below quantifiable limit less than (\<) 0.1 ng/mL.
OG0010.735± 0.2221
OG0021.315± 1.0492
OG003
Part 1 Cohort 5: TAK-788 160 mg
TAK-788 160 mg, capsule, orally, once under fasted conditions on Day 1.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0036
OG0046
Title
Denominators
Categories
TAK-788
Title
Measurements
OG0006.0(2 to 8.08)
OG0015.0(4 to 6)
OG0024.0(4 to 8)
OG0036.0(2 to 6)
OG0046.0(4 to 6)
Metabolite AP32960
Title
Measurements
OG0006.0(2 to 8.08)
OG0014.0(4 to 6)
OG0024.0(2 to 6)
OG003
Metabolite AP32914
Title
Measurements
OG000NA(NA to NA)Data could not be derived since concentration values were below quantifiable limit \< 0.1 ng/mL.
OG0016.0(4 to 8)
OG0024.0(4 to 8)
OG003
OG004
Part 1 Cohort 5: TAK-788 160 mg
TAK-788 160 mg, capsule, orally, once under fasted conditions on Day 1.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0036
OG0046
Title
Denominators
Categories
TAK-788
Title
Measurements
OG00059.4± 7.07
OG001155.2± 112.06
OG002250.4± 197.25
OG003448.3± 184.43
OG0041007.8± 596.14
Metabolite AP32960
Title
Measurements
OG00032.7± 6.41
OG00174.9± 21.89
OG002159.3± 77.04
OG003
Metabolite AP32914
Title
Measurements
OG000NA± NAData could not be derived since concentration values were below quantifiable limit less than 0.1 ng/mL.
OG00111.53± 6.092
OG00214.59± 11.845
OG003
OG004
Part 1 Cohort 5: TAK-788 160 mg
TAK-788 160 mg, capsule, orally, once under fasted conditions on Day 1.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0036
OG0046
Title
Denominators
Categories
TAK-788
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0046
Title
Measurements
OG00063.6± 7.11
OG001160.4± 115.57
OG002256.9± 203.43
OG003
Metabolite AP32960
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0036
Metabolite AP32914
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0025
ParticipantsOG0036
OG004
Part 1 Cohort 5: TAK-788 160 mg
TAK-788 160 mg, capsule, orally, once under fasted conditions on Day 1.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0036
OG0046
Title
Denominators
Categories
TAK-788
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0046
Title
Measurements
OG00018.07± 1.477
OG00115.95± 4.593
OG00214.25± 4.310
OG003
Metabolite AP32960
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0036
Metabolite AP32914
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0025
ParticipantsOG0036
OG004
Part 3: TAK-788 160 mg DiC A
TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 1.
OG005
Part 3: TAK-788 160 mg DiC B
TAK-788 160 mg, DiC B (test), orally, under fasted condition, once, on Day 1 of Intervention Period 1.
Units
Counts
Participants
OG0006
OG0016
OG00210
OG00310
OG00412
OG00513
Title
Denominators
Categories
Title
Measurements
OG0003
OG0013
OG0027
OG0035
OG0044
OG0054
OG004
Part 3: TAK-788 160 mg DiC A
TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 1.
OG005
Part 3: TAK-788 160 mg DiC B
TAK-788 160 mg, DiC B (test), orally, under fasted condition, once, on Day 1 of Intervention Period 1.
Units
Counts
Participants
OG0006
OG0016
OG00210
OG00310
OG00412
OG00513
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG004
Part 3: TAK-788 160 mg DiC A
TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 1.
OG005
Part 3: TAK-788 160 mg DiC B
TAK-788 160 mg, DiC B (test), orally, under fasted condition, once, on Day 1 of Intervention Period 1.
Units
Counts
Participants
OG0006
OG0016
OG00210
OG00310
OG00412
OG00513
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG004
Part 3: TAK-788 160 mg DiC A
TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 1.
OG005
Part 3: TAK-788 160 mg DiC B
TAK-788 160 mg, DiC B (test), orally, under fasted condition, once, on Day 1 of Intervention Period 1.
Units
Counts
Participants
OG0006
OG0016
OG00210
OG00310
OG00412
OG00513
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
2 affected
6 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0081 affected10 at risk
EG0091 affected10 at risk
EG0100 affected13 at risk
EG0111 affected12 at risk
1 affected
6 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0061 affected6 at risk
EG0070 affected6 at risk
EG0081 affected10 at risk
EG0091 affected10 at risk
EG0100 affected13 at risk
EG0110 affected12 at risk
1 affected
6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0081 affected10 at risk
EG0090 affected10 at risk
EG0100 affected13 at risk
EG0110 affected12 at risk
0 affected
6 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected10 at risk
EG0090 affected10 at risk
EG0100 affected13 at risk
EG0110 affected12 at risk
0 affected
6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected10 at risk
EG0090 affected10 at risk
EG0100 affected13 at risk
EG0110 affected12 at risk
0 affected
6 at risk
EG0041 affected6 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected10 at risk
EG0090 affected10 at risk
EG0100 affected13 at risk
EG0110 affected12 at risk
0 affected
6 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0061 affected6 at risk
EG0071 affected6 at risk
EG0080 affected10 at risk
EG0090 affected10 at risk
EG0100 affected13 at risk
EG0110 affected12 at risk
0 affected
6 at risk
EG0041 affected6 at risk
EG0050 affected6 at risk
EG0061 affected6 at risk
EG0070 affected6 at risk
EG0080 affected10 at risk
EG0090 affected10 at risk
EG0100 affected13 at risk
EG0110 affected12 at risk
0 affected
6 at risk
EG0042 affected6 at risk
EG0050 affected6 at risk
EG0062 affected6 at risk
EG0070 affected6 at risk
EG0083 affected10 at risk
EG0091 affected10 at risk
EG0100 affected13 at risk
EG0110 affected12 at risk
0 affected
6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0081 affected10 at risk
EG0090 affected10 at risk
EG0100 affected13 at risk
EG0110 affected12 at risk
1 affected
6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0081 affected10 at risk
EG0090 affected10 at risk
EG0100 affected13 at risk
EG0110 affected12 at risk
0 affected
6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0081 affected10 at risk
EG0090 affected10 at risk
EG0100 affected13 at risk
EG0110 affected12 at risk
1 affected
6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected10 at risk
EG0090 affected10 at risk
EG0100 affected13 at risk
EG0110 affected12 at risk
0 affected
6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0071 affected6 at risk
EG0080 affected10 at risk
EG0090 affected10 at risk
EG0100 affected13 at risk
EG0110 affected12 at risk
0 affected
6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected10 at risk
EG0090 affected10 at risk
EG0100 affected13 at risk
EG0110 affected12 at risk
0 affected
6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected10 at risk
EG0090 affected10 at risk
EG0100 affected13 at risk
EG0110 affected12 at risk
0 affected
6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected10 at risk
EG0091 affected10 at risk
EG0100 affected13 at risk
EG0110 affected12 at risk
0 affected
6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0081 affected10 at risk
EG0090 affected10 at risk
EG0100 affected13 at risk
EG0110 affected12 at risk
0 affected
6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0071 affected6 at risk
EG0080 affected10 at risk
EG0091 affected10 at risk
EG0100 affected13 at risk
EG0111 affected12 at risk
0 affected
6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0071 affected6 at risk
EG0080 affected10 at risk
EG0091 affected10 at risk
EG0100 affected13 at risk
EG0110 affected12 at risk
0 affected
6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0061 affected6 at risk
EG0070 affected6 at risk
EG0080 affected10 at risk
EG0090 affected10 at risk
EG0100 affected13 at risk
EG0110 affected12 at risk
0 affected
6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0071 affected6 at risk
EG0080 affected10 at risk
EG0090 affected10 at risk
EG0100 affected13 at risk
EG0110 affected12 at risk
0 affected
6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0081 affected10 at risk
EG0090 affected10 at risk
EG0100 affected13 at risk
EG0110 affected12 at risk
0 affected
6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0071 affected6 at risk
EG0080 affected10 at risk
EG0090 affected10 at risk
EG0100 affected13 at risk
EG0110 affected12 at risk
0 affected
6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected10 at risk
EG0091 affected10 at risk
EG0100 affected13 at risk
EG0110 affected12 at risk
0 affected
6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0081 affected10 at risk
EG0090 affected10 at risk
EG0100 affected13 at risk
EG0110 affected12 at risk
0 affected
6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0061 affected6 at risk
EG0070 affected6 at risk
EG0080 affected10 at risk
EG0090 affected10 at risk
EG0100 affected13 at risk
EG0110 affected12 at risk
0 affected
6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0061 affected6 at risk
EG0071 affected6 at risk
EG0080 affected10 at risk
EG0090 affected10 at risk
EG0100 affected13 at risk
EG0110 affected12 at risk
0 affected
6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0071 affected6 at risk
EG0080 affected10 at risk
EG0090 affected10 at risk
EG0100 affected13 at risk
EG0110 affected12 at risk
0 affected
6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0061 affected6 at risk
EG0070 affected6 at risk
EG0080 affected10 at risk
EG0090 affected10 at risk
EG0100 affected13 at risk
EG0110 affected12 at risk
0 affected
6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected10 at risk
EG0090 affected10 at risk
EG0101 affected13 at risk
EG0110 affected12 at risk
0 affected
6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected10 at risk
EG0090 affected10 at risk
EG0101 affected13 at risk
EG0110 affected12 at risk
0 affected
6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected10 at risk
EG0090 affected10 at risk
EG0100 affected13 at risk
EG0111 affected12 at risk
0 affected
6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected10 at risk
EG0090 affected10 at risk
EG0101 affected13 at risk
EG0110 affected12 at risk
0 affected
6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected10 at risk
EG0090 affected10 at risk
EG0101 affected13 at risk
EG0110 affected12 at risk
0 affected
6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected10 at risk
EG0090 affected10 at risk
EG0100 affected13 at risk
EG0111 affected12 at risk
0 affected
6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected10 at risk
EG0090 affected10 at risk
EG0100 affected13 at risk
EG0111 affected12 at risk
0 affected
6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected10 at risk
EG0090 affected10 at risk
EG0101 affected13 at risk
EG0110 affected12 at risk
0 affected
6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected10 at risk
EG0090 affected10 at risk
EG0100 affected13 at risk
EG0111 affected12 at risk
0 affected
6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected10 at risk
EG0090 affected10 at risk
EG0101 affected13 at risk
EG0110 affected12 at risk
0 affected
6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected10 at risk
EG0090 affected10 at risk
EG0101 affected13 at risk
EG0110 affected12 at risk
0 affected
6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected10 at risk
EG0090 affected10 at risk
EG0101 affected13 at risk
EG0110 affected12 at risk
0 affected
6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected10 at risk
EG0090 affected10 at risk
EG0100 affected13 at risk
EG0111 affected12 at risk
13.417
± 5.5667
OG00425.411± 10.7473
2.036
± 0.6433
OG0044.051± 1.8778
6.0
(6 to 6)
OG0045.0(4 to 6)
6.0
(6 to 6)
OG0046.0(4 to 6)
284.0
± 125.52
OG004538.5± 196.10
31.74
± 11.370
OG00480.40± 47.696
456.1
± 187.20
OG0041017.3± 599.11
ParticipantsOG0046
Title
Measurements
OG00037.4± 6.23
OG00179.8± 22.41
OG002165.9± 81.28
OG003293.4± 124.35
OG004548.0± 198.24
ParticipantsOG0046
Title
Measurements
OG000NA± NAData could not be derived since concentration values were below quantifiable limit less than 0.1 ng/mL.
OG00119.27± 3.111
OG00220.34± 12.714
OG00334.58± 11.482
OG00485.16± 48.623
18.30
± 1.286
OG00419.85± 5.464
ParticipantsOG0046
Title
Measurements
OG00023.96± 3.461
OG00121.43± 2.979
OG00222.19± 1.137
OG00328.93± 5.903
OG00429.18± 6.368
ParticipantsOG0046
Title
Measurements
OG000NA± NAData could not be derived since concentration values were below quantifiable limit less than 0.1 ng/mL.