A Study of Selexipag in Healthy Male Participant

NCT04266756 | Completed Phase 1

• 3 other identifiers: CR1087092019-004150-2967896049PAH1001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Maximum Observed Analyte Concentration (Cmax) of Selexipag and ACT-333679

  The Cmax is the maximum observed analyte concentration.

  Predose and 0 to 72 hours postdose

• Area Under Analyte Concentration From Time Zero to the Last Quantifiable Concentration (AUC [0-last]) of Selexipag and ACT-333679

  AUC (0-last) defined as the area under the analyte concentration-time curve from time zero to time of the last measurable (non-BQL) analyte concentration, calculated by linear-linear trapezoidal summation.

  Predose and 0 to 72 hours postdose

• Plasma analyte concentration 24 hours (C24) Post Dose of Selexipag and ACT-333679

  C24 defined as plasma analyte concentration at 24 hours postdose.

  Predose and 0 to 72 hours postdose

• Area Under the Analyte Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])

  AUC (0-infinity) is defined the area under the analyte concentration-time curve from time zero to infinity time, calculated as the sum of AUC (0-last) and C(last)/lambda(z); wherein AUC (0-last) is area under the plasma concentration-time curve from time zero to last measurable concentration, C(last) is the last observed measurable concentration, and lambda(z) is apparent terminal elimination rate constant.

  Predose and 0 to 72 hours postdose

Secondary Outcomes (1)

• Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

  Up to 50 Days

Study Arms (2)

Cohort 1: Selexipag Matrix Tablets

EXPERIMENTAL

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.

Drug: Selexipag matrix tablet; Drug: Selexipag Immediate-release (IR) tablet

Cohort 2: Selexipag Encapsulated Pellets

EXPERIMENTAL

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.

Drug: Selexipag encapsulated pellets; Drug: Selexipag Immediate-release (IR) tablet

Interventions

Selexipag matrix tablet DRUG

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

Also known as: JNJ-67896049

Cohort 1: Selexipag Matrix Tablets

Selexipag encapsulated pellets DRUG

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

Also known as: JNJ-67896049

Cohort 2: Selexipag Encapsulated Pellets

Selexipag Immediate-release (IR) tablet DRUG

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

Also known as: JNJ-67896049

Cohort 1: Selexipag Matrix Tablets; Cohort 2: Selexipag Encapsulated Pellets

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Actelion: lead

Study Sites (1)

Clinical Pharmacology Unit

Merksem, 2170, Belgium

Location

MeSH Terms

Interventions

Tablets

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Janssen-Cilag International NV Clinical Trial

  Janssen-Cilag International NV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 12, 2020
• Study Start: January 23, 2020
• Primary Completion: August 14, 2020
• Study Completion: August 14, 2020
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)