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

Idorsia Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Healthy Subjects

Treatments

Drug: Aprocitentan 25mg

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03586570

ID-080-107

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

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