NCT02068235

Study to Investigate the Absolute Bioavailability of a Single Oral Dose of Ponesimod in Healthy Male Subjects

Single-center, Open-label, Randomized, Two-way Crossover Study to Investigate the Absolute Bioavailability of a Single Oral Dose of Ponesimod in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Actelion · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study consists of a single-dose pilot phase and a randomized, two-way crossover, single-dose main phase.The aim of this study is to evaluate the absolute bioavailability of the oral formulation (tablet) of ponesimod compared to an intravenous (i.v.) ponesimod formulation. Three subjects will be included in the pilot phase and 12 subjects in the main crossover phase.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Ponesimod 5mg i.v.
DRUG	Ponesimod i.v.	Dose and infusion rate will be adjusted according to the results of the pilot phase
DRUG	Ponesimod 10 mg tablet

Timeline

• Start date: 2014-08-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2014-02-21
• Last updated: 2015-05-21

Locations

1 site across 1 country: United Kingdom