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Completed

NCT Number: 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

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.

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Key information

Conditions

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Anaheim Clinical Trials

Anaheim, California, 92801, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aprocitentan 25mg

Drug

Oral tablets in strength of 25 mg

Placebo

Drug

Oral tablets matching aprocitentan tablets

Primary outcomes

  1. Cmax during the first and last dosing interval

    Time frame: From study treatment administration to 216 hours after last administration

  2. Time to reach Cmax (tmax) during the first and last dosing interval

    Time frame: From study treatment administration to 216 hours after last administration

  3. AUCτ on the first and last day of study treatment intake

    Time frame: From study treatment administration to 216 hours after last administration

Sponsors and collaborators

Lead sponsor

Idorsia Pharmaceuticals Ltd.

Industry

Collaborators

  • Janssen Biotech, Inc.

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 13, 2018
Registry last updated
Nov 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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