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

NCT03586570 | Completed Phase 1 FDA Drug

• 1 other identifier: ID-080-107
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Aprocitentan

EXPERIMENTAL

Drug: Aprocitentan 25mg

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Aprocitentan 25mg DRUG

Oral tablets in strength of 25 mg

Aprocitentan

Placebo DRUG

Oral tablets matching aprocitentan tablets

Placebo

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Idorsia Pharmaceuticals Ltd.: lead
• Janssen Biotech, Inc.: collaborator

Study Sites (1)

Anaheim Clinical Trials

Anaheim, California, 92801, United States

Location

MeSH Terms

Interventions

aprocitentan

Study Officials

• Clinical Trials

  Idorsia Pharmaceuticals Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: July 13, 2018
• Study Start: July 17, 2018
• Primary Completion: September 10, 2018
• Study Completion: September 10, 2018
• Last Updated: November 23, 2022

Record last verified: 2022-11

Locations

US (1)