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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: Aprocitentan 25mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aprocitentan<br> | Drug: Aprocitentan 25mg<br>* Oral tablets in strength of 25 mg<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Oral tablets matching aprocitentan tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |