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Potential Pharmacokinetic Interaction Between Selexipag and Midazolam in Healthy Male Subjects

NCT02791815 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2016-10-13

No results posted yet for this study

Summary

The primary purpose of this study is to evaluate the effect of repeated doses of selexipag on the pharmacokinetics of a single oral dose of midazolam (i.e., how long and how much midazolam is present in the blood)

Conditions

  • Healthy Subjects

Interventions

DRUG

Midazolam

Single oral dose of 7.5 mg midazolam (tablet)

DRUG

Selexipag

Oral administration of selexipag (200 µg film-coated tablet) for 12 consecutive days (with a titration scheme from 400 to 1600 μg b.i.d. )

Sponsors & Collaborators

  • Actelion

    lead INDUSTRY

Principal Investigators

  • Pierre-Eric Juif, 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
2016-07-31
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • France

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 NCT02791815 on ClinicalTrials.gov