HealthyPhase 1NCT04266756
A Study of Selexipag in Healthy Male Participant
A Phase 1 study testing Selexipag matrix tablet, Selexipag encapsulated pellets and Selexipag Immediate-release (IR) tablet in people with Healthy, run by Actelion at 1 site in Belgium.
Trial summary
The purpose of this study is to evaluate the pharmacokinetic (PK) of selexipag and ACT-333679 following single oral administration of the matrix tablet and the encapsulated pellets of selexipag, each with 3 different release profiles, as compared to selexipag immediate release (IR) tablets in healthy male participants. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Selexipag matrix tablet, Selexipag encapsulated pellets and Selexipag Immediate-release (IR) tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBelgium
- Study dates
- 23 Jan 2020to 14 Aug 2020
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
- Healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the participants may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
- Must sign an informed consent form (ICF) indicating they understand the purpose of, and procedures required for, the study and is willing to participate in the study
- Body mass index (BMI; weight (kilogram [kg]/height^2 [meter {m}]^2) between 18.0 and 28.0 kilogram per square centimeter (kg/m^2) (inclusive), and body weight not less than 50.0 kg at screening
- Blood pressure (after the participant is supine for 5 minutes) between 90 and 145 millimeters of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic at screening. If blood pressure is out of range, up to 2 repeated assessments within the screening period are permitted, last assessment being conclusive
Who cannot join
- Clinically significant abnormal values for hematology, biochemistry, or urinalysis at screening and on Day -1 of Treatment Period 1 as deemed appropriate by the investigator
- Known allergies, hypersensitivity, or intolerance to selexipag or its excipients
- Any contraindication included in the Summary of Product Characteristics (SmPC) of selexipag
- History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study treatments (appendectomy and herniotomy allowed, cholecystectomy not allowed)
- Previous history of stroke, fainting, collapse, syncope, orthostatic hypotension, vasovagal reactions, head injury
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Open-label, Randomized, Formulation Screening, Two-cohort, Four-period, Crossover Study for Selexipag Sustained Release in Healthy Male Subjects
The purpose of this study is to evaluate the pharmacokinetic (PK) of selexipag and ACT-333679 following single oral administration of the matrix tablet and the encapsulated pellets of selexipag, each with 3 different release profiles, as compared to selexipag immediate release (IR) tablets in healthy male participants.
- Conditions
- Healthy
- Being tested
- Selexipag matrix tablet, Selexipag encapsulated pellets, Selexipag Immediate-release (IR) tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selexipag matrix tabletDrug
Also called JNJ-67896049
Participants will receive single oral dose of Selexipag tablet(with fast, medium, and slow release profile) under fasted condition.
Selexipag encapsulated pelletsDrug
Also called JNJ-67896049
Participants will receive single oral dose of Selexipag pellets (with fast, medium, and slow release profile) under fasted condition.
Selexipag Immediate-release (IR) tabletDrug
Also called JNJ-67896049
Participants will receive Selexipag immediate-release tablet orally under fasted condition.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Selexipag Matrix Tablets | Experimental | Participants will receive oral doses of selexipag matrix tablets based on release profiles (IR=immediate release, F=fast release, M=medium release and S=slow release) in treatment sequence 1 (IR+F+M+S), treatment sequence 2 (F+S+IR+M), treatment sequence 3 (M+ IR+ S+F) and treatment sequence 4 (S+M+F+IR) in periods 1, 2, 3, and 4, respectively under fasted condition. A washout period of at least 7 days will be maintained between each treatment period. Receives: Drug: Selexipag matrix tablet; Drug: Selexipag Immediate-release (IR) tablet |
| Cohort 2: Selexipag Encapsulated Pellets | Experimental | Participants will receive oral doses of selexipag encapsulated) pellets based on release profiles (IR=immediate release, F=fast release, M=medium release and S=slow release) in treatment sequence 1 (IR+F+M+S), treatment sequence 2 (F+S+IR+M), treatment sequence 3 (M+ IR+ S+F) and treatment sequence 4 (S+M+F+IR) in periods 1, 2, 3, and 4, respectively under fasted condition. A washout period of at least 7 days will be maintained between each treatment period. Receives: Drug: Selexipag encapsulated pellets; Drug: Selexipag Immediate-release (IR) tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Analyte Concentration (Cmax) of Selexipag and ACT-333679
The Cmax is the maximum observed analyte concentration.
Measured: Predose and 0 to 72 hours postdose
Area Under Analyte Concentration From Time Zero to the Last Quantifiable Concentration (AUC [0-last]) of Selexipag and ACT-333679
AUC (0-last) defined as the area under the analyte concentration-time curve from time zero to time of the last measurable (non-BQL) analyte concentration, calculated by linear-linear trapezoidal summation.
Measured: Predose and 0 to 72 hours postdose
Plasma analyte concentration 24 hours (C24) Post Dose of Selexipag and ACT-333679
C24 defined as plasma analyte concentration at 24 hours postdose.
Measured: Predose and 0 to 72 hours postdose
Area Under the Analyte Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])
AUC (0-infinity) is defined the area under the analyte concentration-time curve from time zero to infinity time, calculated as the sum of AUC (0-last) and C(last)/lambda(z); wherein AUC (0-last) is area under the plasma concentration-time curve from time zero to last measurable concentration, C(last) is the last observed measurable concentration, and lambda(z) is apparent terminal elimination rate constant.
Measured: Predose and 0 to 72 hours postdose
Secondary outcomes (1)
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment and can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product.
Measured: Up to 50 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start23 Jan 2020
- Primary completion14 Aug 2020
- Study completion14 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actelion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag International NV Clinical Trial, Study director, Janssen-Cilag International NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04266756
- Sponsor's protocol ID
- CR108709
- Other IDs
- 2019-004150-29, 67896049PAH1001, 2019
- Status last verified
- Mar 2025
- First submitted
- 10 Feb 2020
- Last updated
- 30 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open-label, Randomized, Formulation Screening, Two-cohort, Four-period, Crossover Study for Selexipag Sustained Release in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT04266756
- Acronym / sponsor ID
- CR108709
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- ActelionIndustry (pharma, biotech, devices)
- Study start
- 23 Jan 2020 (actual)
- Primary completion
- 14 Aug 2020 (actual)
- Study completion
- 14 Aug 2020 (actual)
- First posted
- 12 Feb 2020 (actual)
- 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.
The purpose of this study is to evaluate the pharmacokinetic (PK) of selexipag and ACT-333679 following single oral administration of the matrix tablet and the encapsulated pellets of selexipag, each with 3 different release profiles, as compared to selexipag immediate release (IR) tablets in healthy male participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Selexipag Matrix Tablets | Experimental | Drug: Selexipag matrix tablet, Drug: Selexipag Immediate-release (IR) tabletParticipants will receive oral doses of selexipag matrix tablets based on release profiles (IR=immediate release, F=fast release, M=medium release and S=slow release) in treatment sequence 1 (IR+F+M+S), treatment sequence 2 (F+S+IR+M), treatment sequence 3 (M+ IR+ S+F) and treatment sequence 4 (S+M+F+IR) in periods 1, 2, 3, and 4, respectively under fasted condition. A washout period of at least 7 days will be maintained between each treatment period. |
| Cohort 2: Selexipag Encapsulated Pellets | Experimental | Drug: Selexipag encapsulated pellets, Drug: Selexipag Immediate-release (IR) tabletParticipants will receive oral doses of selexipag encapsulated) pellets based on release profiles (IR=immediate release, F=fast release, M=medium release and S=slow release) in treatment sequence 1 (IR+F+M+S), treatment sequence 2 (F+S+IR+M), treatment sequence 3 (M+ IR+ S+F) and treatment sequence 4 (S+M+F+IR) in periods 1, 2, 3, and 4, respectively under fasted condition. A washout period of at least 7 days will be maintained between each treatment period. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
- Healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the participants may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
- Must sign an informed consent form (ICF) indicating they understand the purpose of, and procedures required for, the study and is willing to participate in the study
- Body mass index (BMI; weight (kilogram [kg]/height^2 [meter {m}]^2) between 18.0 and 28.0 kilogram per square centimeter (kg/m^2) (inclusive), and body weight not less than 50.0 kg at screening
- Blood pressure (after the participant is supine for 5 minutes) between 90 and 145 millimeters of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic at screening. If blood pressure is out of range, up to 2 repeated assessments within the screening period are permitted, last assessment being conclusive
Key exclusion criteria (5 listed)
- Clinically significant abnormal values for hematology, biochemistry, or urinalysis at screening and on Day -1 of Treatment Period 1 as deemed appropriate by the investigator
- Known allergies, hypersensitivity, or intolerance to selexipag or its excipients
- Any contraindication included in the Summary of Product Characteristics (SmPC) of selexipag
- History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study treatments (appendectomy and herniotomy allowed, cholecystectomy not allowed)
- Previous history of stroke, fainting, collapse, syncope, orthostatic hypotension, vasovagal reactions, head injury
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 matrix tabletAlso: JNJ-67896049Participants will receive single oral dose of Selexipag tablet(with fast, medium, and slow release profile) under fasted condition. | Drug | Cohort 1: Selexipag Matrix Tablets |
| Selexipag encapsulated pelletsAlso: JNJ-67896049Participants will receive single oral dose of Selexipag pellets (with fast, medium, and slow release profile) under fasted condition. | Drug | Cohort 2: Selexipag Encapsulated Pellets |
| Selexipag Immediate-release (IR) tabletAlso: JNJ-67896049Participants will receive Selexipag immediate-release tablet orally under fasted condition. | Drug | Cohort 1: Selexipag Matrix Tablets, Cohort 2: Selexipag Encapsulated Pellets |
Primary outcome
Maximum Observed Analyte Concentration (Cmax) of Selexipag and ACT-333679
Time frame: Predose and 0 to 72 hours postdose
The Cmax is the maximum observed analyte concentration.
Area Under Analyte Concentration From Time Zero to the Last Quantifiable Concentration (AUC [0-last]) of Selexipag and ACT-333679
Time frame: Predose and 0 to 72 hours postdose
AUC (0-last) defined as the area under the analyte concentration-time curve from time zero to time of the last measurable (non-BQL) analyte concentration, calculated by linear-linear trapezoidal summation.
Plasma analyte concentration 24 hours (C24) Post Dose of Selexipag and ACT-333679
Time frame: Predose and 0 to 72 hours postdose
C24 defined as plasma analyte concentration at 24 hours postdose.
Area Under the Analyte Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])
Time frame: Predose and 0 to 72 hours postdose
AUC (0-infinity) is defined the area under the analyte concentration-time curve from time zero to infinity time, calculated as the sum of AUC (0-last) and C(last)/lambda(z); wherein AUC (0-last) is area under the plasma concentration-time curve from time zero to last measurable concentration, C(last) is the last observed measurable concentration, and lambda(z) is apparent terminal elimination rate constant.
1 secondary outcome
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Time frame: Up to 50 Days
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 30 Mar 2025.
- Individual participant dataSharing planned: Yes. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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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.
Janssen-Cilag International NV Clinical Trial study director
Janssen-Cilag International NV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Selexipag matrix tablet, Selexipag encapsulated pellets and Selexipag Immediate-release (IR) tablet in people with Healthy, run by Actelion at 1 site in Belgium.
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 5 inclusion and 5 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 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Maximum Observed Analyte Concentration (Cmax) of Selexipag and ACT-333679 (time frame: Predose and 0 to 72 hours postdose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Mar 2025.