A Study of Two Macitentan Pediatric Formulations in Healthy Adult Participants

NCT ID: NCT04963439

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-08
• Study Completion Date: 2021-10-05

Brief Summary

The purpose of this study is to assess the rate and extent of absorption of macitentan following administration of a single oral dose of macitentan formulated as final market image (FMI) (test), compared to macitentan as the clinical service formulation (CSF) under fasted conditions in healthy adult participants.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Treatment Sequence AB

Participants will receive single oral dose of macitentan formulated as final market image (FMI) in fasted conditions (test) (Treatment A) in treatment period 1 followed by a single oral dose of macitentan as the clinical service formulation (CSF) in fasted conditions (reference) (Treatment B) in treatment period 2 on Day 1. Study intervention intake in subsequent intervention periods in an individual participant will be separated by a washout period of at least 10 days.

Group Type: EXPERIMENTAL

Macitentan

Intervention Type: DRUG

Macitentan dispersible tablets will be administered orally as per assigned treatment sequence.

Treatment Sequence BA

Participants will receive Treatment B in treatment period 1 followed by Treatment A in treatment period 2 on Day 1. Study intervention intake in subsequent intervention periods in an individual participant will be separated by a washout period of at least 10 days.

Group Type: EXPERIMENTAL

Macitentan

Intervention Type: DRUG

Macitentan dispersible tablets will be administered orally as per assigned treatment sequence.

Interventions

Macitentan

Macitentan dispersible tablets will be administered orally as per assigned treatment sequence.

Intervention Type: DRUG

Other Intervention Names

Opsumit; ACT-064992

Eligibility Criteria

Inclusion Criteria

• Healthy on the basis of physical examination, medical and surgical history collected at screening. If there are abnormalities, the participant may be included only if the investigator judges the abnormalities to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
• Systolic blood pressure (SBP) between 100 and 145 millimeters of mercury (mmHg) (inclusive) and diastolic blood pressure (DBP) between 50 and 90 mmHg (inclusive) at screening, preferably measured on the right arm, supine after 5 minutes of rest and standing after 3 minutes
• Twelve-lead electrocardiogram (ECG) with heart rate between 45 and 90 beats per minute (bpm) and without clinically relevant abnormalities, at the discretion of the investigator, measured after the participant is supine for at least 5 minutes, at screening
• Body weight not less than 50.0 kilograms (kg) and body mass index (BMI) between 18.5 and 30.0 kilograms per meter square (kg/m^2) (inclusive)
• All women must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta- hCG]) pregnancy test at screening and must have a negative urine pregnancy test on Day -1 of each intervention period

Exclusion Criteria

• Known allergies, hypersensitivity, or intolerance to macitentan or drugs of the same class, or any excipients of the drug formulations
• Taken any disallowed therapies, concomitant therapy within 14 days (or longer, based on elimination half-life) before administration of study intervention in the first intervention period
• Received an investigational intervention (including investigational vaccines) or used an invasive investigational medical device within 30 days or 10 half-lives (whichever is longer) before study intervention intake in the first intervention period, or received a biological product within 3 months or 10 half-lives (whichever is longer) before study intervention intake in the first intervention period, or is currently enrolled in an investigational study
• Values of hepatic aminotransferase (alanine aminotransferase and/or aspartate aminotransferase) greater than (>) 1.5 * upper limit of normal at screening
• Positive results from the human immunodeficiency virus (HIV) (type 1 and 2) serology at screening

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Actelion

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Actelion Clinical Trial

Role: STUDY_DIRECTOR

Actelion

Locations

Clinical Pharmacology Unit

Merksem, , Belgium

Countries

Belgium

Other Identifiers

2021-001258-67

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

67896062PAH1008

Identifier Type: OTHER

Identifier Source: secondary_id

CR109027

Identifier Type: -

Identifier Source: org_study_id