Clinical trial NCT03586570: A Study to Evaluate How Aprocitentan is Safe and How it is Absorbed and Broken Down in the Body of Japanese and Caucasian Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Idorsia Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Janssen Biotech, Inc.
First posted: 2018-07-13
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: Cmax during the first and last dosing interval
timeFrame: From study treatment administration to 216 hours after last administration
measure: Time to reach Cmax (tmax) during the first and last dosing interval
timeFrame: From study treatment administration to 216 hours after last administration
measure: AUCτ on the first and last day of study treatment intake
timeFrame: From study treatment administration to 216 hours after last administration
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials
state: California
Study officials:
affiliation: Idorsia Pharmaceuticals Ltd.
name: Clinical Trials
role: STUDY_DIRECTOR
References: