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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02745860
Other study ID # AC-065-112
Secondary ID
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


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
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