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Completed

NCT Number: NCT02745860

Comparison of Two Dose Strengths of Selexipag in Healthy Adults

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

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Key information

Conditions

Healthy Subjects

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Selexipag (adult formulation)

Drug

One selexipag film-coated tablet of 200 µg

Other names: ACT-293987

Selexipag (pediatric formulation)

Drug

Four selexipag film-coated tablets of 50 µg

Other names: ACT-293987

Primary outcomes

  1. Area under plasma concentration-time curve [AUC(0-inf)] of selexipag and ACT-333679

    Time frame: 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

  2. Maximum plasma concentration (Cmax) of selexipag and ACT-333679

    Time frame: 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 outcomes

  1. Time to reach Cmax (tmax) of selexipag and ACT-333679

    Time frame: 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

  2. Terminal half-life (t½) of selexipag and ACT-333679

    Time frame: 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

  3. Area under plasma concentration-time curve [AUC(0-t)] of selexipag and ACT-333679

    Time frame: 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

  4. Incidence of treatment-emergent adverse events and serious adverse events

    Time frame: 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

  5. Incidence of safety events of interest

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Actelion

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 20, 2016
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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