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

Millennium Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: TAK-788; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03482453

TAK-788-1001

U1111-1208-9582 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 69 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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69 participants in 9 patient groups

Part 1 Cohort 1: TAK-788

Experimental group

Description:

TAK-788, capsule, orally or TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1.

Treatment:

Drug: TAK-788

Drug: Placebo

Drug: TAK-788

Part 1 Cohort 2: TAK-788

Experimental group

Description:

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.

Treatment:

Drug: TAK-788

Drug: Placebo

Drug: TAK-788

Part 1 Cohort 3: TAK-788

Experimental group

Description:

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.

Treatment:

Drug: TAK-788

Drug: Placebo

Drug: TAK-788

Part 1 Cohort 4: TAK-788

Experimental group

Description:

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.

Treatment:

Drug: TAK-788

Drug: Placebo

Drug: TAK-788

Part 1 Cohort 5: TAK-788

Experimental group

Description:

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.

Treatment:

Drug: TAK-788

Drug: Placebo

Drug: TAK-788

Part 2: TAK-788 Fed + TAK-788 Fasted

Experimental group

Description:

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.

Treatment:

Drug: TAK-788

Drug: TAK-788

Part 2: TAK-788 Fasted + TAK-788 Fed

Experimental group

Description:

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.

Treatment:

Drug: TAK-788

Drug: TAK-788

Part 3: TAK-788 DiC (reference) + TAK-788 DiC (test)

Experimental group

Description:

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.

Treatment:

Drug: TAK-788

Drug: TAK-788

Part 3: TAK-788 DiC (test) + TAK-788 DiC (reference)

Experimental group

Description:

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.

Treatment:

Drug: TAK-788

Drug: TAK-788