A Study of Selexipag in Healthy Male Participant

NCT ID: NCT04266756

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-23
• Study Completion Date: 2020-08-14

Brief Summary

The purpose of this study is to evaluate the pharmacokinetic (PK) of selexipag and ACT-333679 following single oral administration of the matrix tablet and the encapsulated pellets of selexipag, each with 3 different release profiles, as compared to selexipag immediate release (IR) tablets in healthy male participants.

Conditions

Healthy

Study Design

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

Study Groups

Cohort 1: Selexipag Matrix Tablets

Participants will receive oral doses of selexipag matrix tablets based on release profiles (IR=immediate release, F=fast release, M=medium release and S=slow release) in treatment sequence 1 (IR+F+M+S), treatment sequence 2 (F+S+IR+M), treatment sequence 3 (M+ IR+ S+F) and treatment sequence 4 (S+M+F+IR) in periods 1, 2, 3, and 4, respectively under fasted condition. A washout period of at least 7 days will be maintained between each treatment period.

Group Type: EXPERIMENTAL

Selexipag matrix tablet

Intervention Type: DRUG

Participants will receive single oral dose of Selexipag tablet(with fast, medium, and slow release profile) under fasted condition.

Selexipag Immediate-release (IR) tablet

Intervention Type: DRUG

Participants will receive Selexipag immediate-release tablet orally under fasted condition.

Cohort 2: Selexipag Encapsulated Pellets

Participants will receive oral doses of selexipag encapsulated) pellets based on release profiles (IR=immediate release, F=fast release, M=medium release and S=slow release) in treatment sequence 1 (IR+F+M+S), treatment sequence 2 (F+S+IR+M), treatment sequence 3 (M+ IR+ S+F) and treatment sequence 4 (S+M+F+IR) in periods 1, 2, 3, and 4, respectively under fasted condition. A washout period of at least 7 days will be maintained between each treatment period.

Group Type: EXPERIMENTAL

Selexipag encapsulated pellets

Intervention Type: DRUG

Participants will receive single oral dose of Selexipag pellets (with fast, medium, and slow release profile) under fasted condition.

Selexipag Immediate-release (IR) tablet

Intervention Type: DRUG

Participants will receive Selexipag immediate-release tablet orally under fasted condition.

Interventions

Selexipag matrix tablet

Participants will receive single oral dose of Selexipag tablet(with fast, medium, and slow release profile) under fasted condition.

Intervention Type: DRUG

Selexipag encapsulated pellets

Participants will receive single oral dose of Selexipag pellets (with fast, medium, and slow release profile) under fasted condition.

Intervention Type: DRUG

Selexipag Immediate-release (IR) tablet

Participants will receive Selexipag immediate-release tablet orally under fasted condition.

Intervention Type: DRUG

Other Intervention Names

JNJ-67896049; JNJ-67896049; JNJ-67896049

Eligibility Criteria

Inclusion Criteria

• Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
• Healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the participants may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
• Must sign an informed consent form (ICF) indicating they understand the purpose of, and procedures required for, the study and is willing to participate in the study
• Body mass index (BMI; weight (kilogram [kg]/height^2 [meter {m}]^2) between 18.0 and 28.0 kilogram per square centimeter (kg/m^2) (inclusive), and body weight not less than 50.0 kg at screening
• Blood pressure (after the participant is supine for 5 minutes) between 90 and 145 millimeters of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic at screening. If blood pressure is out of range, up to 2 repeated assessments within the screening period are permitted, last assessment being conclusive

Exclusion Criteria

• Clinically significant abnormal values for hematology, biochemistry, or urinalysis at screening and on Day -1 of Treatment Period 1 as deemed appropriate by the investigator
• Known allergies, hypersensitivity, or intolerance to selexipag or its excipients
• Any contraindication included in the Summary of Product Characteristics (SmPC) of selexipag
• History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study treatments (appendectomy and herniotomy allowed, cholecystectomy not allowed)
• Previous history of stroke, fainting, collapse, syncope, orthostatic hypotension, vasovagal reactions, head injury

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

Sponsors

Actelion

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen-Cilag International NV Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag International NV

Locations

Clinical Pharmacology Unit

Merksem, , Belgium

Countries

Belgium

Other Identifiers

2019-004150-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

67896049PAH1001

Identifier Type: OTHER

Identifier Source: secondary_id

CR108709

Identifier Type: -

Identifier Source: org_study_id