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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2016-07-31

Brief Summary

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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).

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Detailed Description

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Because non-clinical studies have shown that selexipag and its active metabolite, ACT-333679, are substrates for cytochrome P450 2C8 (CYP2C8), the present clinical study aims at investigating the effect of a strong inhibitor (gemfibrozil) and a moderate inducer (rifampicin) of CYP2C8 on the pharmacokinetic of selexipag and ACT-333679 as recommended by the FDA's Guidance for Industry Drug Interaction Studies (FDA, 2012).

Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Part 1, sequence AB

Subjects participate in two study periods: During the first period (Treatment A), they receive oral selexipag on Day 1. During the second period (Treatment B), they receive multiple oral dose of gemfibrozil from Day 1 to Day 9. Subjects also receive a single oral dose of selexipag on Day 4 concomitantly with gemfibrozil. There is a washout period of 14 to 21 days between the two periods.

Group Type EXPERIMENTAL

Selexipag

Intervention Type DRUG

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

Gemfibrozil

Intervention Type DRUG

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

Part 1, sequence BA

Subjects participate in two study periods: During the first period (Treatment B), they receive multiple oral dose of gemfibrozil from Day 1 to Day 9. They also receive a single oral dose of selexipag on Day 4 concomitantly with gemfibrozil. During the second period (Treatment A) they receive oral selexipag on Day 1. There is a washout period of 14 to 21 days between the two periods.

Group Type EXPERIMENTAL

Selexipag

Intervention Type DRUG

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

Gemfibrozil

Intervention Type DRUG

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

Part 2, sequence AB

Subjects participate in two study periods: During the first period (Treatment A), they receive oral selexipag on Day 1. During the second period (Treatment B), they receive rifampicin once daily from Day 1 to Day 9. Subjects also receive a single oral dose of selexipag on Day 7 together with the dose of rifampicin.There is a washout period of 14 to 21 days between the two periods.

Group Type EXPERIMENTAL

Selexipag

Intervention Type DRUG

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

Rifampicin

Intervention Type DRUG

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

Part 2, sequence BA

Subjects participate in two study periods: During the first period (Treatment B), they receive rifampicin once daily from Day 1 to Day 9. Subjects also receive a single oral dose of selexipag on Day 7 together with the dose of rifampicin. During the second period (Treatment A), they receive oral selexipag on Day 1. There is a washout period of 14 to 21 days between the two periods.

Group Type EXPERIMENTAL

Selexipag

Intervention Type DRUG

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

Rifampicin

Intervention Type DRUG

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

Interventions

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Selexipag

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

Intervention Type DRUG

Gemfibrozil

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

Intervention Type DRUG

Rifampicin

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

Intervention Type DRUG

Other Intervention Names

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ACT-293987

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent form.
* Male subjects aged between 18 and 55 years (inclusive) at screening.
* Body mass index of 18.0 to 28.0 kg/m2 (inclusive) at screening.
* Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests at screening.

Exclusion Criteria

* Any contraindication to gemfibrozil or rifampicin treatment.
* History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might put the subject at risk of participation in the study or interfere with the absorption, distribution, metabolism or excretion of the study treatments.
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes