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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: Aprocitentan 25mg; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Anaheim Clinical Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Oral tablets matching aprocitentan tablets
Experimental: Aprocitentan	Drug: Aprocitentan 25mg; Oral tablets in strength of 25 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cmax during the first and last dosing interval	From study treatment administration to 216 hours after last administration
Time to reach Cmax (tmax) during the first and last dosing interval	From study treatment administration to 216 hours after last administration
AUCτ on the first and last day of study treatment intake	From study treatment administration to 216 hours after last administration

Collaborators and Investigators

• Sponsor: Idorsia Pharmaceuticals Ltd.
• Collaborators: Janssen Biotech, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2018
• Primary Completion (Actual): September 10, 2018
• Study Completion (Actual): September 10, 2018

Study Registration Dates

• First Submitted: July 2, 2018
• First Submitted That Met QC Criteria: July 2, 2018
• First Posted (Actual): July 13, 2018

Study Record Updates

• Last Update Posted (Actual): November 23, 2022
• Last Update Submitted That Met QC Criteria: November 22, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: ID-080-107

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No