A Study to Evaluate How Aprocitentan is Safe and How it is Absorbed and Broken Down in the Body of Japanese and Caucasian Subjects
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 20 - 45 |
Updated: | 10/19/2018 |
Start Date: | July 17, 2018 |
End Date: | September 10, 2018 |
A Single-center, Double-blind, Placebo-controlled, Randomized Study to Investigate the Tolerability, Safety, and Pharmacokinetics After Multiple-dose Administration of 25 mg Aprocitentan in Healthy Japanese and Caucasian Subjects
The objective of this study is to evaluate the tolerability, safety, and pharmacokinetics
after multiple-dose administration of aprocitentan (25 mg) in healthy Japanese and Caucasian
subjects.
after multiple-dose administration of aprocitentan (25 mg) in healthy Japanese and Caucasian
subjects.
Inclusion Criteria:
- Subjects must be of Caucasian or Japanese ethnicity
- Signed informed consent in a language understandable to the subject prior to any
study-mandated procedure
- Body mass index (BMI) of 18.0 to 28.0 kg/m2 (inclusive) at Screening
- Systolic blood pressure 100-145 mmHg, diastolic blood pressure 50-90 mmHg, and pulse
rate 45-90 bpm (inclusive), measured on the same arm, after 5 min in the supine
position at Screening
- A woman of childbearing potential is eligible only if the following applies:
Negative serum pregnancy test at Screening,
Negative urine pregnancy test on Day -1,
Agreement to consistently and correctly use a reliable method of contraception from
Screening up to at least 30 days after last study treatment administration
Japanese subjects only
- Subjects must be of native Japanese descent (all parents/grandparents of Japanese
descent).
- Subjects must not have been away from Japan for more than 10 years (at Screening
visit).
- Subject's lifestyle should not have changed significantly since relocation from Japan
Exclusion Criteria:
- Previous exposure to aprocitentan and/or macitentan.
- Known hypersensitivity to aprocitentan or treatments of the same class, or any of the
excipients
- Pregnant or lactating women
- Any circumstances or conditions, which, in the opinion of the investigator, may affect
full participation in the study or compliance with the protocol
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