Dose Finding Study Clinical Trial
Official title:
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Sequential-Panel, Ascending Single- and Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TAK-438 in Healthy Western Male Subjects, Preliminary Food Effect Analysis, and an Ethnic Comparison With Japanese Subjects
The primary purpose of this study was to evaluate the safety, tolerability, and pharmacokinetics of TAK-438 following single or multiple doses of TAK-438 in healthy Western men, to investigate the effect of food on the pharmacokinetics of TAK-438, and to compare the TAK-438 pharmacokinetics of Western with Japanese men.
The drug being tested in this study is called TAK-438. TAK-438 is being tested to find a
safe and well-tolerated dose. This study looked at the pharmacodynamic and pharmacokinetic
properties (how the drug moves throughout the body) of the drug and safety (lab results and
side effects) in people who took TAK-438.
This study was designed to consist of 4 sequential substudies: a single rising dose study
(Cohorts 1 to 7), a food-effect study (Cohort 8), a multiple rising dose study (Cohorts 9 to
11), and a Japanese bridging study (Cohort 12). However, the protocol was halted during the
food effect study (Cohort 8) following the discovery of previously unidentified metabolites
and as a result, the multiple rising dose (Cohorts 9-11) and ethnicity (Cohort 12) studies
were not carried out.
The study population for each of Cohorts 1 to 7 consisted of 9 subjects; with 6 subjects
randomized to receive a single dose of TAK-438, and 3 subjects to receive placebo. Subjects
in Cohorts 1 to 7 received a single dose of study drug after a 10-hour fast. The starting
dose was 1 mg followed by administrations of 5, 10, 20, 15, 40, and 30 mg.
In Cohort 8 the plan was to assign 12 participants in a 2-sequence, 2-period crossover
design. Six participants were to receive a single dose of TAK-438 on Day 1, in the fasted
state, followed by a second single dose of TAK-438 on Day 15 in the alternative fed state.
The other 6 participants were to receive the study drug like-wise but in the fed then fasted
state.
To investigate the effect of multiple dosing, a further 3 cohorts (Cohorts 9-11), each
comprising 12 participants were to be introduced to the protocol following completion of the
single rising dose study. A final cohort, Cohort 12, consisting of 24 Western participants
and 24 Japanese participants was to be used to assess the effect of TAK-438 and esomeprazole
on the safety, tolerability, pharmacokinetics and pH of the stomach between these 2 ethnic
groups.
This single-centre trial was conducted in the United Kingdom.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| 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 |
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 |
NCT02334982 -
Safety, Tolerability and Pharmacokinetics of Escalating Single Doses of TAK-137 in Healthy Participants
|
Phase 1 | |
| Completed |
NCT03595189 -
Safety, Tolerability and Pharmacokinetic Profile of an Infusion of Cilastatin in Healthy Volunteers.
|
Phase 1 |