A Study of Two Macitentan Formulations in Healthy Adult Participants

Actelion Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Macitentan

Study type: Interventional

Funder types: Industry

Identifiers

NCT05433675

67896062PAH1010 (Other Identifier)

2022-000262-17 (EudraCT Number)

CR109185

Details and patient eligibility

About

The purpose of this study is to evaluate the bioequivalence of macitentan on the primary pharmacokinetics (PK) parameters between the dispersible final market image (FMI) macitentan tablet and the opsumit tablet in healthy adult participants in fasted conditions.

Enrollment: 28 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy on the basis of physical examination, medical and surgical history performed at screening. If there are any abnormalities, they must be considered not clinically relevant and this determination must be recorded in the participant's source documents and initialed by the investigator
• Body weight not less than 50 kilograms (kg) and body mass index (BMI) within the range 18.5 - 30.0 kilogram per meter square (kg/m^2)(inclusive), at screening
• 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
• A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 30 days after the last study intervention intake
• Must sign an ICF indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study, before starting any screening activities

Exclusion criteria

• Known allergies, hypersensitivity, or intolerance to macitentan, fructose or drugs of the same class, or any excipients of the drug formulations
• History or clinical evidence of any disease or existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism, or excretion of the study intervention (appendectomy and herniotomy allowed, cholecystectomy not allowed)
• A history of repeated fainting due to cardiac cause, collapse, syncope, orthostatic hypotension, or vasovagal reactions
• Veins unsuitable for intravenous puncture on either arm (example, veins that are difficult to locate, access, or puncture, and veins with a tendency to rupture during or after puncture)
• Woman who is breastfeeding/pregnant at screening or plans to breastfeed/become pregnant throughout the study until 30 days after last study intervention intake

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Treatment Sequence AB

Experimental group

Description:

Participants will receive single oral dose of macitentan formulated as dispersible final market image (FMI) in fasted conditions (test) (Treatment A) in Intervention Period 1 followed by a single oral dose of film-coated opsumit tablet in fasted conditions (reference) (Treatment B) in Intervention Period 2 on Day 1. There will be washout period of at least 10 days between two period.

Treatment:

Drug: Macitentan

Treatment Sequence BA

Experimental group

Description:

Participants will receive Treatment B in Intervention Period 1 followed Treatment A in Intervention Period 2 on Day 1. There will be washout period of at least 10 days between two period.

Treatment:

Drug: Macitentan