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

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: Aprocitentan 25mg; Drug: Placebo

• Registration Number: NCT03586570
• Lead Sponsor: Idorsia Pharmaceuticals Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-02
• Study First Submitted QC: 2018-07-02
• Study First Posted: 2018-07-13
• Study Start: 2018-07-17
• Primary Completion: 2018-09-10
• Study Completion: 2018-09-10
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-22
• Last Update Posted: 2022-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aprocitentan	Aprocitentan 25mg	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
AUCτ on the first and last day of study treatment intake	From study treatment administration to 216 hours after last administration
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

Trial Locations

Locations (1)

Anaheim Clinical Trials; 🇺🇸 Anaheim, California, United States