drugset / Trial / NCT03482453

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

NCT03482453

Phase 1 Completed 69 enrolled Millennium Pharmaceuticals, Inc.
RandomizedSequentialTriple-blindOther

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.

Timeline

Start
2018-03-28
Primary completion
2018-12-22
Completion
2019-01-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Mobocertinib Small molecule 160 mg Oral

Indications

No indication recorded.