Conditions: Dose Finding Study
Keywords: Drug therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 47
Healthy volunteers: yes

Brief summary:
The purpose of this study is to characterize the safety and tolerability profile of TAK-137 when administered as a single dose of tablets at escalating dose levels in healthy participants.

Detailed description:
The drug being tested in this study is called TAK-137. TAK-137 is being tested to find a safe and well-tolerated dose. This study looked at safety (lab results and side effects) and pharmacokinetic properties (drug absorption, distribution, metabolism, and excretion) in people who took TAK-137. This study was designed as a single ascending 6 Cohort dose study with planned doses of 2, 5, 15, 50, and 100 mg and Cohort 6 dose to be determined if the maximum tolerated dose (MTD) was not reached. Anticipated enrollment was 48.

This study enrolled 47 participants and consisted of 6 Cohorts. Participants in Cohorts 1, 2, 3, 5 and 6 were randomized to receive a single dose of TAK-137 or placebo after a 10-hour fast. Participants in Cohort 4 were randomized to receive a single dose of TAK-137 or placebo under fasted conditions, followed by a single dose of TAK-137 or placebo under fed conditions 14 days later. Participants in cohort 4 will receive the same dose in both fasted and fed conditions. The starting dose was 2 mg followed by administrations of 5, 10, 0.5 and 20 mg.

This single-center trial was conducted in the United States. For Cohorts 1, 2, 3, 5, and 6 the overall time to participate in this study was up to 42 days. Participants made 4 visits to the clinic including one 5-day period of confinement to the clinic, and were contacted by telephone 14 days after last dose of study drug for a follow-up assessment.

For Cohort 4 the overall time to participate in this study was up to 56 days. Participants made 7 visits to the clinic including two 5-day periods of confinement to the clinic, and were contacted by telephone 14 days after last dose of study drug for a follow-up assessment.

Arms:
arm 1: TAK-137 2 mg, tablets, orally, once on Day 1. arm 2: TAK-137 5 mg, tablets, orally, once on Day 1. arm 3: TAK-137 10 mg, tablets, orally, once on Day 1. arm 4: TAK-137 5 mg, tablets, orally, under fasted conditions, once on Day 1 of Period 1, followed by 14 days of follow-up, followed by TAK-137 5 mg, tablets, orally, under fed conditions, once on Day 1 of Period 2. arm 5: TAK-137 0.5 mg, tablets, orally, once on Day 1. arm 6: TAK-137 20 mg, tablets, orally, once on Day 1. arm 7: TAK-137 placebo-matching tablets, orally, once on Day 1.

Interventions: intervention 1: TAK-137 intervention 2: Placebo
Intervention descriptions: intervention 1: TAK-137 tablets intervention 2: TAK-137 placebo-matching tablets

Protocol document: