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

NCT02068235 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2015-05-21

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Actelion

    lead INDUSTRY

Principal Investigators

  • Daniela Baldoni, PharmD, PhD · Actelion

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • United Kingdom

Study Locations

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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 NCT02068235 on ClinicalTrials.gov