Expired Study
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Anaheim, California 92801


Purpose:

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.


Criteria:

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


NCT ID:

NCT03586570


Primary Contact:

Study Director
Clinical Trials
Idorsia Pharmaceuticals Ltd.


Backup Contact:

N/A


Location Contact:

Anaheim, California 92801
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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