BioequivalencePhase 1NCT02206295
Study in Healthy Male Subjects to Demonstrate Bioequivalence of 1600 μg Selexipag Administered as Eight Tablets of 200 μg or as Single Tablet of 1600 μg
A Phase 1 study testing selexipag in people with Bioequivalence, run by Actelion.
Trial summary
The primary aim of this study is to demonstrate bioequivalence in the rate and extent of absorption between 1600 μg selexipag test drug (administered orally as film-coated tablets of 1600 μg, twice a day (b.i.d.) and 1600 μg selexipag reference drug (administered orally as 8 film-coated tablets of 200 μg b.i.d.) at… 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
- Bioequivalence
- What is being tested?
- selexipag
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to Dec 2012
- 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
- Signed informed consent in the local language prior to any study-mandated procedure.
- Healthy male subjects aged between 18 and 55 years (inclusive) at Screening.
- No clinically significant findings on the physical examination at Screening.
- Body mass index of 18.0 to 30.0 kg/m^2 (inclusive) at Screening.
- Systolic blood pressure 100-145 mmHg, diastolic blood pressure 50-90 mmHg, and pulse rate 45-90 beats per minute (all inclusive), measured at Screening.
- 12-lead electrocardiogram without clinically relevant abnormalities, measured at Screening.
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- Hematology, clinical chemistry, and urinalysis test results not deviating from the normal range to a clinically relevant extent at Screening.
- Negative results from urine drug screen and alcohol breath test at Screening.
- Ability to communicate well with the investigator, in the local language, and to understand and comply with the requirements of the study.
Who cannot join
- Known allergic reactions or hypersensitivity to selexipag or any excipient of the drug formulation used in this study.
- 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 selexipag.
- Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions.
- Veins unsuitable for intravenous puncture on either arm (e.g., veins that are difficult to locate, access or puncture; veins with a tendency to rupture during or after puncture).
- Treatment with selexipag or another investigational drug within 1 month prior to Screening or 5 half-lives, whichever is longer.
- History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to Screening.
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- Excessive caffeine consumption at Screening.
- Smoking within 3 months prior to Screening and inability to refrain from smoking during the course of the study.
- Previous treatment with any prescribed medications (including vaccines) or over-the-counter medications within 2 weeks prior to first study drug administration.
- Loss of 500 mL or more of blood within 3 months prior to Screening.
- Positive results from the hepatitis serology (hepatitis B antigen and hepatitis C antibodies), except for vaccinated subjects or subjects with past but resolved hepatitis, at Screening.
- Positive results from the human immunodeficiency virus serology at Screening.
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
- Legal incapacity or limited legal capacity at Screening.
About this study
Official title: A Single-center, Open-label, Randomized, Two-period, Two-treatment, Crossover Study in Healthy Male Subjects to Demonstrate Bioequivalence of 1600 μg Selexipag Administered as Eight Tablets of 200 μg (Reference Drug) or as Single Tablet of 1600 μg (Test Drug)
The primary aim of this study is to demonstrate bioequivalence in the rate and extent of absorption between 1600 μg selexipag test drug (administered orally as film-coated tablets of 1600 μg, twice a day (b.i.d.) and 1600 μg selexipag reference drug (administered orally as 8 film-coated tablets of 200 μg b.i.d.) at steady-state in healthy male subjects following a multiple-dose up-titration scheme.
- Conditions
- Bioequivalence
- Being tested
- selexipag
- Keywords
- selexipag, ACT-333679
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
selexipagDrug
| Study group | Role | What they receive |
|---|---|---|
| Treatment Sequence AB | Experimental | Subjects will receive Treatment A in Period 1 followed by Treatment B in Period 2. There will be a washout period lasting at least 6 days between treatments.
Treatment A: up-titration from Day 1-18 will performed in 200 μg steps every fourth day with multiples of 200 μg film-coated tablets starting with 400 μg selexipag b.i.d. The up-titration will be followed by treatment with 8 film-coated tablets, 200 μg each, b.i.d. from Day 19 to the morning dose of Day 23.
Treatment B: up-titration from Day 1-18 will be performed in 200 μg steps every fourth day with multiples of 200 μg film-coated tablets starting with 400 μg selexipag b.i.d. The up-titration will be followed by treatment with one single film-coated tablet, 1600 μg, b.i.d. from Day 19 to the morning dose of Day 23. Receives: Drug: selexipag |
| Treatment Sequence BA | Experimental | Subjects will receive Treatment B in Period 1 followed by Treatment A in Period 2. There will be a washout period lasting at least 6 days between treatments.
Treatment A: up-titration from Day 1-18 will performed in 200 μg steps every fourth day with multiples of 200 μg film-coated tablets starting with 400 μg selexipag b.i.d. The up-titration will be followed by treatment with 8 film-coated tablets, 200 μg each, b.i.d. from Day 19 to the morning dose of Day 23.
Treatment B: up-titration from Day 1-18 will be performed in 200 μg steps every fourth day with multiples of 200 μg film-coated tablets starting with 400 μg selexipag b.i.d. The up-titration will be followed by treatment with one single film-coated tablet, 1600 μg, b.i.d. from Day 19 to the morning dose of Day 23. Receives: Drug: selexipag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve (AUCt) for selexipag
Blood will be collected by direct venipuncture or via an intravenous catheter placed in an arm vein after 4.5 days' treatment with 1600 μg selexipag b.i.d. during Treatments A and B. Selexipag will be quantified in plasma samples using a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) assay. AUCt will be calculated according to the linear trapezoidal rule using the measured concentration-time values above the limit of quantification during one dosing interval.
Measured: 23 days
Maximum plasma concentration at steady state (Cmax,ss) for selexipag
Blood will be collected by direct venipuncture or via an intravenous catheter placed in an arm vein after 4.5 days' treatment with 1600 μg selexipag b.i.d. during Treatments A and B. Selexipag will be quantified in plasma samples using a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) assay. The measured individual plasma concentrations of selexipag will be used to directly obtain Cmax,ss.
Measured: 23 days
Secondary outcomes (19)
Area under the plasma concentration-time curve (AUCt) for ACT-333679
Blood will be collected by direct venipuncture or via an intravenous catheter placed in an arm vein after 4.5 days' treatment with 1600 μg selexipag b.i.d. during Treatments A and B. ACT-333679 will be quantified in plasma samples using a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) assay. AUCt will be calculated according to the linear trapezoidal rule using the measured concentration-time values above the limit of quantification during one dosing interval.
Measured: 23 days
Maximum plasma concentration at steady state (Cmax,ss) for ACT-333679
Blood will be collected by direct venipuncture or via an intravenous catheter placed in an arm vein after 4.5 days' treatment with 1600 μg selexipag b.i.d. during Treatments A and B. ACT-333679 will be quantified in plasma samples using a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) assay. The measured individual plasma concentrations of ACT-333679 will be used to directly obtain Cmax,ss.
Measured: 23 days
Time to reach maximum plasma concentration at steady state (tmax,ss) for selexipag
Blood will be collected by direct venipuncture or via an intravenous catheter placed in an arm vein after 4.5 days' treatment with 1600 μg selexipag b.i.d. during Treatments A and B. Selexipag will be quantified in plasma samples using a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) assay. The measured individual plasma concentrations of selexipag will be used to directly obtain tmax,ss.
Measured: 23 days
Trough plasma concentration at the end of one dose interval (Ctrough) for selexipag
Blood will be collected by direct venipuncture or via an intravenous catheter placed in an arm vein after 4.5 days' treatment with 1600 μg selexipag b.i.d. during Treatments A and B. Selexipag will be quantified in plasma samples using a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) assay. The measured individual plasma concentrations of selexipag will be used to directly obtain Ctrough.
Measured: 23 days
Trough plasma concentration at the end of one dose interval (Ctrough) for ACT-333679
Blood will be collected by direct venipuncture or via an intravenous catheter placed in an arm vein after 4.5 days' treatment with 1600 μg selexipag b.i.d. during Treatments A and B. ACT-333679 will be quantified in plasma samples using a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) assay. The measured individual plasma concentrations of ACT-333679 will be used to directly obtain Ctrough.
Measured: 23 days
Trough plasma concentration at steady state (Ctrough,ss) for selexipag
Blood will be collected by direct venipuncture or via an intravenous catheter placed in an arm vein after 4.5 days' treatment with 1600 μg selexipag b.i.d. during Treatments A and B. Selexipag will be quantified in plasma samples using a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) assay. The measured individual plasma concentrations of selexipag will be used to directly obtain Ctrough,ss.
Measured: 23 days
Trough plasma concentration (Ctrough,ss) for ACT-333679
Blood will be collected by direct venipuncture or via an intravenous catheter placed in an arm vein after 4.5 days' treatment with 1600 μg selexipag b.i.d. during Treatments A and B. ACT-333679 will be quantified in plasma samples using a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) assay. The measured individual plasma concentrations of ACT-333679 will be used to directly obtain Ctrough,ss.
Measured: 23 days
Change in systolic blood pressure from baseline up to end of study
Blood pressure and pulse rate will be measured using an automatic oscillometric device, always on the dominant arm (i.e., dominant arm right = writing with right hand).
Measured: up to 28 days
Change in diastolic blood pressure from baseline up to end of study
Blood pressure and pulse rate will be measured using an automatic oscillometric device, always on the dominant arm (i.e., dominant arm right = writing with right hand).
Measured: up to 28 days
Change in pulse rate from baseline up to end of study
Blood pressure and pulse rate will be measured using an automatic oscillometric device, always on the dominant arm (i.e., dominant arm right = writing with right hand).
Measured: up to 28 days
Change in body weight from baseline up to end of study
Blood pressure and pulse rate will be measured using an automatic oscillometric device, always on the dominant arm (i.e., dominant arm right = writing with right hand).
Measured: up to 28 days
Change in heart rate from baseline up to end of study
Heart rate will be measured using standard 12-lead electrocardiography recorded at rest with the subject in the supine position for a 5 minute period.
Measured: up to 28 days
Change in PQ/PR interval (time interval from the beginning of the P wave to the beginning of the QRS complex) from baseline up to end of study
PQ/PR interval will be measured using standard 12-lead electrocardiography recorded at rest with the subject in the supine position for a 5 minute period.
Measured: up to 28 days
Change in QRS interval (time interval from the beginning of the Q wave to the end of the S wave) from baseline up to end of study
QRS interval will be measured using standard 12-lead electrocardiography recorded at rest with the subject in the supine position for a 5 minute period.
Measured: up to 28 days
Change in QT interval (time interval from beginning of the Q wave until end of the T wave) from baseline up to end of study
QT interval will be measured using standard 12-lead electrocardiography recorded at rest with the subject in the supine position for a 5 minute period.
Measured: up to 28 days
Change in QTcB interval (time interval from beginning of the Q wave until end of the T wave, according to Bazett's correction) from baseline up to end of study
QT interval will be measured using standard 12-lead electrocardiography recorded at rest with the subject in the supine position for a 5 minute period. QTcB will be calculated according to the following formula (QTcB = QT/RR^0.5 where RR is 60/heart rate).
Measured: up to 28 days
Change in QTcF interval (time interval from beginning of the Q wave until end of the T wave, according to Fridericia's correction) from baseline up to end of study
QT interval will be measured using standard 12-lead electrocardiography recorded at rest with the subject in the supine position for a 5 minute period. QTcF will be calculated according to the following formula (QTcF = QT/RR^0.33 where RR is 60/heart rate).
Measured: up to 28 days
Number of treatment-emergent electrocardiogram abnormalities from baseline up to end of study
Electrocardiogram abnormalities will be measured using standard 12-lead electrocardiography recorded at rest with the subject in the supine position for a 5 minute period.
Measured: up to 28 days
Number of participants with adverse events leading to discontinuation of study treatment
Adverse events will be considered as any adverse change from the subject's baseline condition that occurred during the course of the study. The subjects will be required to report any adverse events spontaneously. In addition, each subject will be assessed by the investigator at any measurement timepoint as well as at the end of observation and whenever necessary as deemed by the investigator.
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2014 (estimated)
- Study startSep 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioequivalenceStudies 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actelion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniela Baldoni, PhD, PharmD, Study director, Actelion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02206295
- Sponsor's protocol ID
- AC-065-108
- Status last verified
- Jan 2025
- First submitted
- 30 Jul 2014
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
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
- A Single-center, Open-label, Randomized, Two-period, Two-treatment, Crossover Study in Healthy Male Subjects to Demonstrate Bioequivalence of 1600 μg Selexipag Administered as Eight Tablets of 200 μg (Reference Drug) or as Single Tablet of 1600 μg (Test Drug)
- ClinicalTrials.gov ID
- NCT02206295
- Acronym / sponsor ID
- AC-065-108
- Conditions
- Bioequivalence
- Keywords
- selexipag, ACT-333679
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- ActelionIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 1 Aug 2014 (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.
The primary aim of this study is to demonstrate bioequivalence in the rate and extent of absorption between 1600 μg selexipag test drug (administered orally as film-coated tablets of 1600 μg, twice a day (b.i.d.) and 1600 μg selexipag reference drug (administered orally as 8 film-coated tablets of 200 μg b.i.d.) at steady-state in healthy male subjects following a multiple-dose up-titration scheme.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence AB | Experimental | Drug: selexipagSubjects will receive Treatment A in Period 1 followed by Treatment B in Period 2. There will be a washout period lasting at least 6 days between treatments. Treatment A: up-titration from Day 1-18 will performed in 200 μg steps every fourth day with multiples of 200 μg film-coated tablets starting with 400 μg selexipag b.i.d. The up-titration will be followed by treatment with 8 film-coated tablets, 200 μg each, b.i.d. from Day 19 to the morning dose of Day 23. Treatment B: up-titration from Day 1-18 will be performed in 200 μg steps every fourth day with multiples of 200 μg film-coated tablets starting with 400 μg selexipag b.i.d. The up-titration will be followed by treatment with one single film-coated tablet, 1600 μg, b.i.d. from Day 19 to the morning dose of Day 23. |
| Treatment Sequence BA | Experimental | Drug: selexipagSubjects will receive Treatment B in Period 1 followed by Treatment A in Period 2. There will be a washout period lasting at least 6 days between treatments. Treatment A: up-titration from Day 1-18 will performed in 200 μg steps every fourth day with multiples of 200 μg film-coated tablets starting with 400 μg selexipag b.i.d. The up-titration will be followed by treatment with 8 film-coated tablets, 200 μg each, b.i.d. from Day 19 to the morning dose of Day 23. Treatment B: up-titration from Day 1-18 will be performed in 200 μg steps every fourth day with multiples of 200 μg film-coated tablets starting with 400 μg selexipag b.i.d. The up-titration will be followed by treatment with one single film-coated tablet, 1600 μg, b.i.d. from Day 19 to the morning dose of Day 23. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Signed informed consent in the local language prior to any study-mandated procedure.
- Healthy male subjects aged between 18 and 55 years (inclusive) at Screening.
- No clinically significant findings on the physical examination at Screening.
- Body mass index of 18.0 to 30.0 kg/m^2 (inclusive) at Screening.
- Systolic blood pressure 100-145 mmHg, diastolic blood pressure 50-90 mmHg, and pulse rate 45-90 beats per minute (all inclusive), measured at Screening.
Key exclusion criteria (14 listed)
- Known allergic reactions or hypersensitivity to selexipag or any excipient of the drug formulation used in this study.
- 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 selexipag.
- Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions.
- Veins unsuitable for intravenous puncture on either arm (e.g., veins that are difficult to locate, access or puncture; veins with a tendency to rupture during or after puncture).
- Treatment with selexipag or another investigational drug within 1 month prior to Screening or 5 half-lives, whichever is longer.
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 | Drug | Treatment Sequence AB, Treatment Sequence BA |
Primary outcome
Area under the plasma concentration-time curve (AUCt) for selexipag
Time frame: 23 days
Blood will be collected by direct venipuncture or via an intravenous catheter placed in an arm vein after 4.5 days' treatment with 1600 μg selexipag b.i.d. during Treatments A and B. Selexipag will be quantified in plasma samples using a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) assay. AUCt will be calculated according to the linear trapezoidal rule using the measured concentration-time values above the limit of quantification during one dosing interval.
Maximum plasma concentration at steady state (Cmax,ss) for selexipag
Time frame: 23 days
Blood will be collected by direct venipuncture or via an intravenous catheter placed in an arm vein after 4.5 days' treatment with 1600 μg selexipag b.i.d. during Treatments A and B. Selexipag will be quantified in plasma samples using a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) assay. The measured individual plasma concentrations of selexipag will be used to directly obtain Cmax,ss.
19 secondary outcomes
Area under the plasma concentration-time curve (AUCt) for ACT-333679
Time frame: 23 days
Maximum plasma concentration at steady state (Cmax,ss) for ACT-333679
Time frame: 23 days
Time to reach maximum plasma concentration at steady state (tmax,ss) for selexipag
Time frame: 23 days
Trough plasma concentration at the end of one dose interval (Ctrough) for selexipag
Time frame: 23 days
Trough plasma concentration at the end of one dose interval (Ctrough) for ACT-333679
Time frame: 23 days
Trough plasma concentration at steady state (Ctrough,ss) for selexipag
Time frame: 23 days
Trough plasma concentration (Ctrough,ss) for ACT-333679
Time frame: 23 days
Change in systolic blood pressure from baseline up to end of study
Time frame: up to 28 days
Change in diastolic blood pressure from baseline up to end of study
Time frame: up to 28 days
Change in pulse rate from baseline up to end of study
Time frame: up to 28 days
Change in body weight from baseline up to end of study
Time frame: up to 28 days
Change in heart rate from baseline up to end of study
Time frame: up to 28 days
Change in PQ/PR interval (time interval from the beginning of the P wave to the beginning of the QRS complex) from baseline up to end of study
Time frame: up to 28 days
Change in QRS interval (time interval from the beginning of the Q wave to the end of the S wave) from baseline up to end of study
Time frame: up to 28 days
Change in QT interval (time interval from beginning of the Q wave until end of the T wave) from baseline up to end of study
Time frame: up to 28 days
Change in QTcB interval (time interval from beginning of the Q wave until end of the T wave, according to Bazett's correction) from baseline up to end of study
Time frame: up to 28 days
Change in QTcF interval (time interval from beginning of the Q wave until end of the T wave, according to Fridericia's correction) from baseline up to end of study
Time frame: up to 28 days
Number of treatment-emergent electrocardiogram abnormalities from baseline up to end of study
Time frame: up to 28 days
Number of participants with adverse events leading to discontinuation of study treatment
Time frame: up to 28 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 3 Feb 2025.
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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.
Daniela Baldoni, PhD, PharmD study director
Actelion
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing selexipag in people with Bioequivalence, 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 9 inclusion and 14 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 the plasma concentration-time curve (AUCt) for selexipag (time frame: 23 days). 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?
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.