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



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:20 - 45
Updated:10/19/2018
Start Date:July 17, 2018
End Date:September 10, 2018

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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

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.


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
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1085 N Harbor Blvd
Anaheim, California 92801
(714) 774-7777
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