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

Healthy Subjects Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03586570
• Other study ID #: ID-080-107
• Status: Completed
• Phase: Phase 1
• Start date: July 17, 2018
• Est. completion date: September 10, 2018

Study information

• Verified date: November 2022
• Source: Idorsia Pharmaceuticals Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 10, 2018
• Est. primary completion date: September 10, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• Aprocitentan 25mg
Oral tablets in strength of 25 mg
• Placebo
Oral tablets matching aprocitentan tablets

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials	Anaheim	California

Sponsors (2)

Lead Sponsor	Collaborator
Idorsia Pharmaceuticals Ltd.	Janssen Biotech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax during the first and last dosing interval		From study treatment administration to 216 hours after last administration
Primary	Time to reach Cmax (tmax) during the first and last dosing interval		From study treatment administration to 216 hours after last administration
Primary	AUCt on the first and last day of study treatment intake		From study treatment administration to 216 hours after last administration