drugset / Trial / NCT02625259

A Study to Evaluate the Relative Bioavailability, Effect of Food, and Gastric Potential Hydrogen (pH) Modification on the Pharmacokinetics of TAK-117 (MLN1117) in Healthy Participants

NCT02625259

Phase 1 Completed 54 enrolled Millennium Pharmaceuticals, Inc.
RandomizedCrossoverOpen-labelTreatment

Summary

The purpose of this study is to evaluate the relative bioavailability of a new tablet formulation of TAK-117 (new clinical trial material \[NTM\]) compared to the TAK-117 Process B capsules (current clinical trial material \[CTM\]) (Part 1), to assess the effects of food on the oral bioavailability and pharmacokinetics (PK) of TAK-117 (Part 2), and to assess the effects of gastric pH-modifying agent on the PK of TAK-117 in healthy participants (Part 3).

Timeline

Start
2016-01-08
Primary completion
2016-05-16
Completion
2016-07-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Serabelisib Small molecule 900 mg Oral
Background Lansoprazole Other / unclassified 30 mg

Indications