At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 48 enrolled
Drug / intervention
TAK-648 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability, and Pharmacokinetic Study of Escalating Multiple Oral TAK-648 Doses in Healthy Japanese Subjects and Subjects With Type 2 Diabetes Mellitus
In Brief
A Phase 1 clinical trial evaluating TAK-648 and Placebo for Type 2 Diabetes Mellitus. Completed, enrolled 48 participants across 2 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartApr 2015
First PostedApr 2015
Primary CompletionSep 2015
Study CompletionNov 2015
TodayJul 2026
First PostedApr 30, 2015
Enrollment StartApr 1, 2015
Primary CompletionSep 1, 2015
Study CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 11.2 years ago
Interventions
TAK-648drug
TAK-648 solution
Placebodrug
TAK-648 placebo-matching solution