Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-01-01 @ 1:26 PM
Study NCT ID:
NCT03237156
Status:
COMPLETED
Last Update Posted:
2021-01-12
First Post:
2017-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase 1 TAK-906 Single and Multiple Ascending Dose Study in Japanese Healthy Male Participants
Sponsor:
Takeda
Organization:
Study Overview
Official Title:
A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-906 in Japanese Healthy Male Subjects
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple oral doses of TAK-906 in Japanese healthy male participants.
Detailed Description:
The drug being tested in this study is called TAK-906. TAK-906 is being tested in healthy participants in order to evaluate safety and tolerability of single and multiple oral doses of TAK-906 in Japanese healthy male participants.
The study will enroll approximately 24 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups in Cohort 1 or Cohort 3. Study drug will be administered in a double-blind manner which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need), orally, once daily on Day 1 as Single Dose Period and twice daily from Day 3 to 7 as Multiple Dose Period:
* TAK-906 50 mg (Cohort 1)
* TAK-906 100 mg (Cohort 2)
* TAK-906 10 mg (Cohort 3)
* Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient
Cohort 2 will be conducted after the completion of Cohort 1. This will be conducted in Japan.
The study will enroll approximately 24 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups in Cohort 1 or Cohort 3. Study drug will be administered in a double-blind manner which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need), orally, once daily on Day 1 as Single Dose Period and twice daily from Day 3 to 7 as Multiple Dose Period:
* TAK-906 50 mg (Cohort 1)
* TAK-906 100 mg (Cohort 2)
* TAK-906 10 mg (Cohort 3)
* Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient
Cohort 2 will be conducted after the completion of Cohort 1. This will be conducted in Japan.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: