Healthy Subjects Clinical Trial
Official title:
Single-center, Open-label, Randomized, Two-way Crossover Study to Compare the Single-dose Pharmacokinetics of Pediatric Minitablet and Adult Capsule Formulations of ACT-709478 in Healthy Male Subjects
This study is for research purposes only and is not intended to treat any medical condition.
The purpose of this study is to evaluate the pharmacokinetics of 2 different formulations of
ACT-709478 in healthy male participants. The participants will be treated in a crossover
design with 2 different treatment periods. Pharmacokinetics (PK) is the study of the
absorption and breakdown of the study drug in the body.
The duration of participation in this study is approximately 8 weeks from screening to the
end of study visit. A screening visit is required within 21 to 3 days prior to the start of
the study to determine whether the participant qualifies and is willing to enter in this
research study. This study requires the participant to have two in-patient stays in the
research clinic. Each in-patient stay is planned for 5 days (4 nights). Eleven days after
each dose the participant will have an examination. There will be an in-between period (i.e.,
time between the end of period 1 and study treatment administration in Period 2) of 7 to 14
days. A safety follow-up telephone call for all participants who have received at least one
study treatment will take place 30 to 40 days after the end of study examination or study
discontinuation.
n/a
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