A Study to Evaluate How Aprocitentan is Safe and How it is Absorbed and Broken Down in the Body of Japanese and Caucasian Subjects

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Subjects

In brief

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.

Key facts

Study ID

NCT03586570

Run by

Idorsia Pharmaceuticals Ltd.

People needed

20

Starts

2018-07-17

Expected to finish

2018-09-10

Last updated by the study team

2022-11-23

Who can join

Age: 20 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Anaheim Clinical Trials — Anaheim, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.