Healthy Volunteers Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-418 in Healthy Female Subjects
The purpose of this study is to characterize safety and tolerability of TAK-418 in non-Japanese and Japanese healthy female participants when administered at single or multiple (once daily [QD]) oral doses.
The drug being tested in this study is called TAK-418. This study will assess the safety,
tolerability, PK and PD of single and multiple rising doses of TAK-418 in healthy Japanese or
non-Japanese females.
The study will enroll approximately 48 participants in 6 cohorts and each cohort will have 8
participants. The study will include 2 parts: single rising dose (SRD) in Cohort 1 and
multiple rising dose (MRD) in Cohorts 2 to 6. Cohort 3 will include cerebrospinal fluid (CSF)
collection. Participants will be randomly assigned (by chance, like flipping a coin) to one
of the 6 cohorts.
This two-center trial will be conducted in the United States. The overall time to participate
in Cohort 1 of this study is approximately 105 days and 98 days in Cohort 2. Participants
will be contacted by telephone 14 days after last dose of study drug for a follow-up
assessment.
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