drugset / Trial / NCT02430870

TAK-648 Multiple-Rising Dose Study in Healthy Japanese Participants and Non-Japanese Participants With Type 2 Diabetes Mellitus

NCT02430870 ↗

Phase 1 Completed 48 enrolled Takeda
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a phase 1, randomized, double-blind, placebo-controlled, 2-center, multiple-dose study in healthy participants and participants with type 2 diabetes mellitus (T2DM). This study will evaluate the safety, tolerability and pharmacokinetics (PK) of TAK-648 when administered as multiple oral doses of TAK-648 solution at escalating dose levels in healthy participants of Japanese decent and participants with T2DM.

Timeline

Start
2015-04
Primary completion
2015-09
Completion
2015-11

Drugs

EvaluationDrugModalityDoseRoute
Subject TAK-648 Unknown 0.05 mg Oral
Subject TAK-648 Unknown 0.15 mg Oral
Subject TAK-648 Unknown 0.35 mg Oral
Subject TAK-648 Unknown 0.8 mg Oral