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A Clinical Study to Investigate the Effect of Gemfibrozil or Rifampicin on Blood Concentrations of Selexipag in Healthy Subjects

NCT02770222 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-02-03

No results posted yet for this study

Summary

The primary objectives of this 2-part drug interaction study are as follows:

* To evaluate the effect of gemfibrozil on the pharmacokinetics (i.e., amount in the blood) of selexipag and its metabolite ACT-333679 (Part I).
* To evaluate the effect of rifampicin on the pharmacokinetics of selexipag and its metabolite ACT-333679 (Part II).

Conditions

  • Healthy Subjects

Interventions

DRUG

Selexipag

Two selexipag film-coated tablets of 200 µg as single oral dose (total dose = 400 µg)

DRUG

Gemfibrozil

Gemfibrozil film-coated tablet of 600 mg administered orally b.i.d. from Day 1 to Day 9

DRUG

Rifampicin

Rifampicin film-coated tablet of 600 mg administered orally o.d.from Day 1 to Day 9

Sponsors & Collaborators

  • Actelion

    lead INDUSTRY

Principal Investigators

  • Shirin Bruderer, PhD · Actelion

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2016-07-31
Completion
2016-07-31

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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 NCT02770222 on ClinicalTrials.gov