Type 2 Diabetes Mellitus Clinical Trial
Official title:
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
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).
The drug being evaluated in this study is TAK-648 for the treatment of T2DM.
This study will consist of 2 parts: (1) multiple ascending doses in participants with T2DM,
(2) multiple ascending doses in healthy participants of Japanese descent.
Part 1 of this study will consist of 2 multiple dose treatment cohorts (Cohorts 1-2
designated as P1C1and P1C2) dosed sequentially in escalating order. The projected doses of
TAK-648 for Part 1 are 0.15 and 0.35 mg of TAK-648, but may be adjusted higher or lower, and
additional cohorts may be added, based on available safety and pharmacokinetic (PK) data.
All cohorts in Part 1 will consist of 8 (2 placebo) T2DM participants.
Part 2 of this study will consist of 3 multiple dose treatment cohorts (Cohorts 1-3
designated as P2C1, P2C2 and P2C3) in healthy participants of Japanese descent dosed
sequentially in escalating order. The projected doses of TAK-648 chosen for Part 2 are 0.05,
0.15 and 0.35 mg of TAK-648, but may be adjusted higher or lower based on available safety
and PK data. All cohorts in Part 2 will consist of 8 (2 placebo) healthy participants of
Japanese descent.
Additional cohorts may be recruited and studied as necessary to better evaluate safety,
tolerability, PK, and/or PD parameters.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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