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, Inc.69 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

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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.

Outcomes

Primary Outcomes

Part 1: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: Baseline up to 30 days after the last dose of study drug (Day 31)

Part 2, Cmax: Maximum Observed Plasma Concentration for TAK-788