Comparison of Two Dose Strengths of Selexipag in Healthy Adults

Healthy Subjects Clinical Trial

Official title:

Single-center, Open-label, Randomized, Two-way Crossover Study in Healthy Adult Male Subjects to Compare the Pharmacokinetics of Selexipag (ACT-293987) Following Single Oral Administration of 4 Film-coated Pediatric Tablets of 50 µg vs One Film-coated Tablet of 200 µg Selexipag

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02745860
• Other study ID #: AC-065-112
• Status: Completed
• Phase: Phase 1
• First received: April 18, 2016
• Last updated: July 1, 2016
• Start date: June 2016
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: Actelion
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug Control
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• Selexipag (adult formulation)
One selexipag film-coated tablet of 200 µg
• Selexipag (pediatric formulation)
Four selexipag film-coated tablets of 50 µg

Locations

Country	Name	City	State
Germany	Investigator Site.	Kiel

Sponsors (1)

Lead Sponsor	Collaborator
Actelion

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under plasma concentration-time curve [AUC(0-inf)] of selexipag and ACT-333679	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	From predose until 72 hours postdose for each treatment period	No
Primary	Maximum plasma concentration (Cmax) of selexipag and ACT-333679	Cmax is directly derived from the individual plasma concentration time curves for selexipag and its metabolite ACT-333679	From predose until 72 hours postdose for each treatment period	No
Secondary	Time to reach Cmax (tmax) of selexipag and ACT-333679	tmax is directly derived from the individual plasma concentration time curves for selexipag and its metabolite ACT-333679	From predose until 72 hours postdose for each treatment period	No
Secondary	Terminal half-life (t½) of selexipag and ACT-333679	The period of time required for the concentration levels of selexipag or its metabolite (ACT-333679) to be reduced by one-half	From predose until 72 hours postdose for each treatment period	No
Secondary	Area under plasma concentration-time curve [AUC(0-t)] of selexipag and ACT-333679	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	From predose until 72 hours postdose for each treatment period	No
Secondary	Incidence of treatment-emergent adverse events and serious adverse events	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	From first administration of selexipag (Day 1 Period 1) to end of study (Day 4, Period 2)	Yes
Secondary	Incidence of safety events of interest	Events of interest include any abnormalities in ECG, vital signs or laboratory test results	From first administration of selexipag (Day 1 Period 1) to end of study (Day 4, Period 2)	Yes