The purpose of this study is to assess the pharmacokinetics and safety of single- and multiple-dose of TAK-491 in healthy Chinese participants.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
64
TAK-491 tablets
TAK-491 placebo-matching tablets
Unnamed facility
Beijing, Beijing,P.R., China
Cmax: Maximum Observed Plasma Concentration for TAK-536 (the Active Moiety Derived From TAK-491) on Day 1
Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Cmax: Maximum Observed Plasma Concentration for TAK-536 (the Active Moiety Derived From TAK-491) on Day 10
Time frame: Day 10 pre-dose and at multiple time points (up to 24 hours) post-dose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-536 (the Active Moiety Derived From TAK-491) on Day 1
Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-536 (the Active Moiety Derived From TAK-491) on Day 10
Time frame: Day 10 pre-dose and at multiple time points (up to 24 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-536 (the Active Moiety Derived From TAK-491) on Day 1
Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
AUC(0-24): Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours Post-dose for TAK-536 (the Active Moiety Derived From TAK-491) on Day 10
Time frame: Day 10 pre-dose and at multiple time points (up to 24 hours) post-dose
Terminal Phase Elimination Half-life (T1/2) for TAK-536 (the Active Moiety Derived From TAK-491) on Day 1
Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
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