Overview
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
Completed
Trial end date:
2018-09-10
2018-09-10
Target enrollment:
0
0
Participant gender:
All
All
Summary
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.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Idorsia Pharmaceuticals Ltd.Collaborator:
Janssen Biotech, Inc.
Criteria
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