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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-17

Study Completion Date

2018-09-10

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.

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Detailed Description

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Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Aprocitentan

Group Type EXPERIMENTAL

Aprocitentan 25mg

Intervention Type DRUG

Oral tablets in strength of 25 mg

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral tablets matching aprocitentan tablets

Interventions

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Aprocitentan 25mg

Oral tablets in strength of 25 mg

Intervention Type DRUG

Placebo

Oral tablets matching aprocitentan tablets

Intervention Type DRUG

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes