Comparison of Two Dose Strengths of Selexipag in Healthy Adults

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2016-06-30

Brief Summary

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Clinical study in healthy adult subjects to compare the adult tablet of selexipag with the tablet developed for children.

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Detailed Description

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Healthy male adults receive a single dose of selexipag (200 µg) but using a different tablet strength (4 film-coated pediatric tablets of 50 µg versus one film-coated tablet of 200 µg selexipag) during each of the two study periods. There is a washout of 7-9 days between the two study treatment administrations.

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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Sequence AB

Subjects receive 200 µg of selexipag (adult formulation) as a single oral dose during Period 1 and 200 µg of selexipag (pediatric formulation) as a single oral dose during Period 2

Group Type EXPERIMENTAL

Selexipag (adult formulation)

Intervention Type DRUG

One selexipag film-coated tablet of 200 µg

Selexipag (pediatric formulation)

Intervention Type DRUG

Four selexipag film-coated tablets of 50 µg

Sequence BA

Subjects receive 200 µg of selexipag (pediatric formulation) as a single oral dose during Period 1 and 200 µg of selexipag (adult formulation) as a single oral dose during Period 2

Group Type EXPERIMENTAL

Selexipag (adult formulation)

Intervention Type DRUG

One selexipag film-coated tablet of 200 µg

Selexipag (pediatric formulation)

Intervention Type DRUG

Four selexipag film-coated tablets of 50 µg

Interventions

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Selexipag (adult formulation)

One selexipag film-coated tablet of 200 µg

Intervention Type DRUG

Selexipag (pediatric formulation)

Four selexipag film-coated tablets of 50 µg

Intervention Type DRUG

Other Intervention Names

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ACT-293987 ACT-293987

Eligibility Criteria

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Inclusion Criteria

* Male subjects aged from 18 to 45 years (inclusive) at screening
* Signed informed consent form
* Body mass index (BMI) between 18.0 and 28.0 kg/m2 (inclusive) at screening
* Healthy on the basis of physical examination,cardiovascular assessments and laboratory tests

Exclusion Criteria

* Any contraindication to the study treatments
* History or clinical evidence of any disease or medical / surgical condition or treatment, which may put the subject at risk of participation in the study or may 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 the subject's full participation in the study or compliance with the protocol

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes