Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-28 @ 12:10 AM
Study NCT ID:
NCT02541669
Status:
COMPLETED
Last Update Posted:
2020-02-05
First Post:
2015-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Single- and Multiple-Dose Study of the Pharmacokinetics of TAK-491 in Healthy Chinese Participants
Sponsor:
Takeda
Organization:
Study Overview
Official Title:
A Randomized, Open-Label and Double-Blind, Placebo-Controlled, Single- and Multiple-Dose, Phase 1 Study of the Pharmacokinetics of TAK-491 40 mg and 80 mg in Healthy Chinese Subjects
Status:
COMPLETED
Status Verified Date:
2020-01
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 assess the pharmacokinetics and safety of single- and multiple-dose of TAK-491 in healthy Chinese participants.
Detailed Description:
The drug being tested in this study is called TAK-491. TAK-491 is being tested to treat people who have hypertension. This study will look at the pharmacokinetics of TAK-491 in Chinese participants who take TAK-491.
The study will enroll approximately 64 participants.
The first 16 enrolled participants have been randomly assigned (by chance, like flipping a coin) to 1 of the 2 treatment groups:
* TAK-491 40 mg
* TAK-491 80 mg
All participants will be asked to take 1 tablet at the same time on Day 1 and Day 4 to 10 during the study.
The following 48 randomized participants will be randomly assigned (by chance, like flipping a coin) to 1 of the 3 treatment groups:
* TAK-491 40 mg
* TAK-491 80 mg
* TAK-491 placebo
All participants will be asked to take two tablets at the same time on Day 1 and Day 4 to 10 during the study.
This single-center trial will be conducted in China. The overall time to participate in this study is approximately 52 days. Participants will be admitted in the clinic for the first 12 days, and will be contacted by telephone 14 days after last dose of study drug for a follow-up assessment.
The study will enroll approximately 64 participants.
The first 16 enrolled participants have been randomly assigned (by chance, like flipping a coin) to 1 of the 2 treatment groups:
* TAK-491 40 mg
* TAK-491 80 mg
All participants will be asked to take 1 tablet at the same time on Day 1 and Day 4 to 10 during the study.
The following 48 randomized participants will be randomly assigned (by chance, like flipping a coin) to 1 of the 3 treatment groups:
* TAK-491 40 mg
* TAK-491 80 mg
* TAK-491 placebo
All participants will be asked to take two tablets at the same time on Day 1 and Day 4 to 10 during the study.
This single-center trial will be conducted in China. The overall time to participate in this study is approximately 52 days. Participants will be admitted in the clinic for the first 12 days, and will be contacted by telephone 14 days after last dose of study drug for a follow-up assessment.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U1111-1159-5559 | OTHER | WHO | View |