Healthy SubjectsPhase 1NCT02745860
Comparison of Two Dose Strengths of Selexipag in Healthy Adults
A Phase 1 study testing Selexipag (adult formulation) and Selexipag (pediatric formulation) in people with Healthy Subjects, run by Actelion.
Trial summary
Clinical study in healthy adult subjects to compare the adult tablet of selexipag with the tablet developed for children. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Selexipag (adult formulation) and Selexipag (pediatric formulation)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Jun 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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 study in healthy adult subjects to compare the adult tablet of selexipag with the tablet developed for children.
Read the 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.
- Conditions
- Healthy Subjects
- Being tested
- Selexipag (adult formulation), Selexipag (pediatric formulation)
- Keywords
- selexipag, pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selexipag (adult formulation)Drug
Also called ACT-293987
One selexipag film-coated tablet of 200 µg
Selexipag (pediatric formulation)Drug
Also called ACT-293987
Four selexipag film-coated tablets of 50 µg
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Selexipag (adult formulation); Drug: Selexipag (pediatric formulation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: From predose until 72 hours postdose for each treatment period
Secondary outcomes (5)
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
Measured: From predose until 72 hours postdose for each treatment period
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
Measured: From predose until 72 hours postdose for each treatment period
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
Measured: From predose until 72 hours postdose for each treatment period
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
Measured: From first administration of selexipag (Day 1 Period 1) to end of study (Day 4, Period 2)
Incidence of safety events of interest
Events of interest include any abnormalities in ECG, vital signs or laboratory test results
Measured: From first administration of selexipag (Day 1 Period 1) to end of study (Day 4, Period 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actelion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Margaux Boehler, Actelion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02745860
- Sponsor's protocol ID
- AC-065-112
- Status last verified
- Jan 2025
- First submitted
- 18 Apr 2016
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 28639216
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02745860
- Acronym / sponsor ID
- AC-065-112
- Conditions
- Healthy Subjects
- Keywords
- selexipag, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- ActelionIndustry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 20 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence AB | Experimental | Drug: Selexipag (adult formulation), Drug: 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 | Experimental | Drug: Selexipag (adult formulation), Drug: 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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 (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selexipag (adult formulation)Also: ACT-293987One selexipag film-coated tablet of 200 µg | Drug | Sequence AB, Sequence BA |
| Selexipag (pediatric formulation)Also: ACT-293987Four selexipag film-coated tablets of 50 µg | Drug | Sequence AB, Sequence BA |
Primary outcome
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
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
5 secondary outcomes
Time to reach Cmax (tmax) of selexipag and ACT-333679
Time frame: From predose until 72 hours postdose for each treatment period
Terminal half-life (t½) of selexipag and ACT-333679
Time frame: From predose until 72 hours postdose for each treatment period
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
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Derived from this study: PubMed 28639216Boehler 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaux Boehler
Actelion
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Selexipag (adult formulation) and Selexipag (pediatric formulation) in people with Healthy Subjects, run by Actelion.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02745860, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.