Dose Finding Study Clinical Trial
Official title:
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetic Study of Escalating Single Doses of TAK-137 in Healthy Subjects
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04730609 -
Dexmedetomidine for Intraoperative Shivering in Scheduled Elective Cesarean Delivery
|
Phase 4 | |
| Completed |
NCT02123953 -
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAK-438 in Healthy Male Participants
|
Phase 1 | |
| Completed |
NCT02141698 -
Safety, Tolerability, and Pharmacokinetics of TAK-438 in Healthy Western Male Subjects, Preliminary Food Effect Analysis, and an Ethnic Comparison With Japanese Subjects
|
Phase 1 | |
| Completed |
NCT02706834 -
Safety, Tolerability and Pharmacokinetics of Escalating Single Doses of TAK-828 in Healthy Participants
|
Phase 1 | |
| Completed |
NCT02153099 -
Safety, Tolerability and Pharmacokinetics of Escalating Single Doses of ENV8058 (TAK-058) in Healthy Participants
|
Phase 1 | |
| Completed |
NCT03595189 -
Safety, Tolerability and Pharmacokinetic Profile of an Infusion of Cilastatin in Healthy Volunteers.
|
Phase 1 |