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
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 2/8/2019 |
| Start Date: | March 28, 2018 |
| End Date: | January 18, 2019 |
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
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.
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.
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 84 participants. The study is designed to consist of 3
parts: Part 1- dose escalation phase, Part 2- food effect phase and Part 3 - relative
bioavailability. The study population of Part 1 will consist of 56 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, a tolerable single dose is to 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 1 cohort,
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 12 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.
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 84 participants. The study is designed to consist of 3
parts: Part 1- dose escalation phase, Part 2- food effect phase and Part 3 - relative
bioavailability. The study population of Part 1 will consist of 56 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, a tolerable single dose is to 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 1 cohort,
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 12 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.
Inclusion Criteria:
1. 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.
2. Nonsmoker (never smoked or greater than [>] 20 years from last occurrence of smoking).
3. Normal organ function including hepatic, renal, and bone marrow function.
Exclusion Criteria:
1. 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.
2. Pulmonary infection ongoing or within 30 days of informed consent.
3. Inability to undergo venipuncture and/or tolerate venous access.
4. Inability to tolerate multiple blood sampling.
5. Ongoing or active infection, including but not limited to, the requirement for
intravenous (IV) antibiotics.
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