NCT02745860

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 20, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

February 3, 2025

Status Verified

January 1, 2025

Enrollment Period

Same day

First QC Date

April 18, 2016

Last Update Submit

January 31, 2025

Conditions

Healthy Subjects

Keywords

selexipagpharmacokinetics

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (5)

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

    From predose until 72 hours postdose for each treatment period

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

    From predose until 72 hours postdose for each treatment period

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

    From predose until 72 hours postdose for each treatment period

  • 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)

  • Incidence of safety events of interest

    From first administration of selexipag (Day 1 Period 1) to end of study (Day 4, Period 2)

Study Arms (2)

Sequence AB

EXPERIMENTAL

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

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

Sequence BA

EXPERIMENTAL

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

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

Interventions

Selexipag (adult formulation)DRUG

One selexipag film-coated tablet of 200 µg

Also known as: ACT-293987
Sequence ABSequence BA
Selexipag (pediatric formulation)DRUG

Four selexipag film-coated tablets of 50 µg

Also known as: ACT-293987
Sequence ABSequence BA

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Boehler M, Bruderer S, Ulc I, Dingemanse J. Biocomparison Study of Adult and Paediatric Dose Strengths of the Prostacyclin Receptor Agonist Selexipag. Eur J Drug Metab Pharmacokinet. 2018 Feb;43(1):115-120. doi: 10.1007/s13318-017-0424-z.

    PMID: 28639216DERIVED

MeSH Terms

Interventions

selexipag

Study Officials

  • Margaux Boehler

    Actelion

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2016

First Posted

April 20, 2016

Study Start

June 1, 2016

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

February 3, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share