drugset
drugset / Trial / NCT02461160

Phase 1, TAK-915-1001, Single-Rising Dose, Multiple-Rising Dose, Drug-Drug Interaction, Relative Bioavailability, Food Effect, and Effect on Elderly Participants Study

NCT02461160 ↗

Phase 1 Completed 88 enrolled Takeda
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to characterize the safety, tolerability and plasma pharmacokinetic (PK) profile of TAK-915 when administered as single and multiple oral suspension doses at escalating dose levels in healthy participants, including elderly participants.

Timeline

Start
2015-05-12
Primary completion
2016-08-01
Completion
2016-08-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Midazolam Small molecule 2 mg Oral
Subject TAK-915 Small molecule 30 mg Oral
Subject TAK-915 Small molecule 50 mg Oral
Subject TAK-915 Small molecule 100 mg Oral
Subject TAK-915 Small molecule 200 mg Oral

Indications

No indication recorded.