Comparison of Two Dose Strengths of Selexipag in Healthy Adults

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: Selexipag (adult formulation); Drug: Selexipag (pediatric formulation)

• Registration Number: NCT02745860
• Lead Sponsor: Actelion

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2016-04-18
• Study First Submitted QC: 2016-04-18
• Study First Posted: 2016-04-20
• Study Start: 2016-06
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence BA	Selexipag (adult formulation)	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
Sequence AB	Selexipag (adult formulation)	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
Sequence AB	Selexipag (pediatric formulation)	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
Sequence BA	Selexipag (pediatric formulation)	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

Primary Outcome Measures

Name	Time	Method
Area under plasma concentration-time curve [AUC(0-inf)] of selexipag and ACT-333679	From predose until 72 hours postdose for each treatment period	AUC(0-inf) is the area under plasma concentration-time curves for selexipag and its metabolite (ACT-333679), calculated from zero to the extrapolated infinite time
Maximum plasma concentration (Cmax) of selexipag and ACT-333679	From predose until 72 hours postdose for each treatment period	Cmax is directly derived from the individual plasma concentration time curves for selexipag and its metabolite ACT-333679

Secondary Outcome Measures

Name	Time	Method
Time to reach Cmax (tmax) of selexipag and ACT-333679	From predose until 72 hours postdose for each treatment period	tmax is directly derived from the individual plasma concentration time curves for selexipag and its metabolite ACT-333679
Terminal half-life (t½) of selexipag and ACT-333679	From predose until 72 hours postdose for each treatment period	The period of time required for the concentration levels of selexipag or its metabolite (ACT-333679) to be reduced by one-half
Area under plasma concentration-time curve [AUC(0-t)] of selexipag and ACT-333679	From predose until 72 hours postdose for each treatment period	AUC(0-t) is the area under plasma concentration-time curves for selexipag and its metabolite (ACT-333679), calculated from zero to time t of the last measured concentration above the limit of quantification
Incidence of treatment-emergent adverse events and serious adverse events	From first administration of selexipag (Day 1 Period 1) to end of study (Day 4, Period 2)	A treatment-emergent AE is any AE temporally associated with the use of a study treatment, whether or not considered related to the study treatment, including any abnormalities in ECG parameters, vital signs or laboratory tests
Incidence of safety events of interest	From first administration of selexipag (Day 1 Period 1) to end of study (Day 4, Period 2)	Events of interest include any abnormalities in ECG, vital signs or laboratory test results

Trial Locations

Locations (1)

Investigator Site.; 🇩🇪 Kiel, Germany