Trials / Completed
CompletedNCT04266756
A Study of Selexipag in Healthy Male Participant
A Single-center, Open-label, Randomized, Formulation Screening, Two-cohort, Four-period, Crossover Study for Selexipag Sustained Release in Healthy Male Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Actelion · Industry
- Sex
- Male
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2020-01-23
- Primary completion
- 2020-08-14
- Completion
- 2020-08-14
- First posted
- 2020-02-12
- Last updated
- 2025-03-30
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT04266756. Inclusion in this directory is not an endorsement.