Comparison of Two Dose Strengths of Selexipag in Healthy Adults

Actelion Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: Selexipag (pediatric formulation); Drug: Selexipag (adult formulation)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02745860

AC-065-112

Details and patient eligibility

About

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

Full description

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.

Enrollment: 20 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key 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

Key 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Sequence AB

Experimental group

Description:

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

Treatment:

Drug: Selexipag (adult formulation)

Drug: Selexipag (pediatric formulation)

Sequence BA

Experimental group

Description:

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

Treatment:

Drug: Selexipag (adult formulation)

Drug: Selexipag (pediatric formulation)