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
• Trial end date: 2019-01-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Millennium Pharmaceuticals, Inc.

Criteria

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.