MedTrace Logo

A Study of Selexipag in Healthy Male Participant

NCT04266756 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-03-30

No results posted yet for this study

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

Interventions

DRUG

Selexipag matrix tablet

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

DRUG

Selexipag encapsulated pellets

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

DRUG

Selexipag Immediate-release (IR) tablet

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

Sponsors & Collaborators

  • Actelion

    lead INDUSTRY

Principal Investigators

  • Janssen-Cilag International NV Clinical Trial · Janssen-Cilag International NV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-23
Primary Completion
2020-08-14
Completion
2020-08-14

Countries

  • Belgium

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04266756 on ClinicalTrials.gov