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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03586570

Enrollment

Registered

2018-07-13

Start date

2018-07-17

Completion date

2018-09-10

Last updated

2022-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

Brief 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.

Interventions

DRUGAprocitentan 25mg

Oral tablets in strength of 25 mg

DRUGPlacebo

Oral tablets matching aprocitentan tablets

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Cmax during the first and last dosing interval	From study treatment administration to 216 hours after last administration
Time to reach Cmax (tmax) during the first and last dosing interval	From study treatment administration to 216 hours after last administration
AUCτ on the first and last day of study treatment intake	From study treatment administration to 216 hours after last administration

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026