Healthy Volunteers Clinical Trial
Official title:
A Single-center, Double-blind, Placebo-controlled, Randomized Study to Investigate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics After Single-dose Administration of 4 mg Cenerimod in Healthy Japanese and Caucasian 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 safety, tolerability, pharmacokinetics (PK) and
pharmacodynamics (PD) of cenerimod following a single dose in healthy Japanese and Caucasian
participants. Pharmacokinetics is the study of the absorption and breakdown of the study drug
in the body. Pharmacodynamics is the study of the effect of the study drug on the body. There
will be 2 groups in the study. 10 Japanese participants in one group and 10 Caucasian
participants in the other group.
The duration of participation in this study is approximately 75 days from screening to the
end of study visit. A screening visit is required within 21 days prior to the start of the
study to determine whether the volunteer qualifies and is willing to participate in this
research study. This study requires in-patient stay in the research clinic of 4 days (3
nights) followed by outpatient visits and an end of study visit 3 to 5 days after the day 49
outpatient visit.
n/a
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