Healthy SubjectsPhase 1NCT02791815
Potential Pharmacokinetic Interaction Between Selexipag and Midazolam in Healthy Male Subjects
A Phase 1 study testing Midazolam and Selexipag in people with Healthy Subjects, run by Actelion at 1 site in France.
Trial summary
The primary purpose of this study is to evaluate the effect of repeated doses of selexipag on the pharmacokinetics of a single oral dose of midazolam (i.e., how long and how much midazolam is present in the blood) 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?
- Midazolam and Selexipag
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2016to Sep 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
- Signed informed consent form
- Age from 18 to 45 years (inclusive) at screening
- Body mass index (BMI) from 18.0 to 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Open-label, Randomized, Two-treatment Crossover Study to Investigate the Effect of Selexipag on the Pharmacokinetics of Midazolam and Its Metabolite 1-hydroxymidazolam in Healthy Male Subjects
The primary purpose of this study is to evaluate the effect of repeated doses of selexipag on the pharmacokinetics of a single oral dose of midazolam (i.e., how long and how much midazolam is present in the blood)
Read the detailed description
In order to exclude an inductive effect of selexipag in the gastrointestinal tract, this study aims at investigating the effect of selexipag on the PK of midazolam, a sensitive substrate of both hepatic and intestinal cytochrome P450 3A4 (CYP3A4).
- Conditions
- Healthy Subjects
- Being tested
- Midazolam, Selexipag
- Keywords
- selexipag, pharmacokinetics, midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
Single oral dose of 7.5 mg midazolam (tablet)
SelexipagDrug
Also called ACT-293987
Oral administration of selexipag (200 µg film-coated tablet) for 12 consecutive days (with a titration scheme from 400 to 1600 μg b.i.d. )
| Study group | Role | What they receive |
|---|---|---|
| Sequence AB | Experimental | Subjects participate in two study periods: During the first period, they receive a single oral dose of midazolam on Day 1. During the second period, they receive oral selexipag alone from Day 1 to Day 11 and selexipag + midazolam on Day 12. There is a washout period of 14 to 21 days between the two periods. Receives: Drug: Midazolam; Drug: Selexipag |
| Sequence BA | Experimental | Subjects participate in two study periods: During the first period, they receive oral selexipag alone from Day 1 to Day 11 and selexipag + midazolam on Day 12. During the second period, they receive a single oral dose of midazolam on Day 1. There is a washout period of 14 to 21 days between the two periods. Receives: Drug: Midazolam; Drug: Selexipag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of midazolam following administration of midazolam alone and in combination with selexipag
Cmax is the maximum observed plasma concentration and is directly derived from the individual plasma concentration time curves of midazolam
Measured: From pre-dose up to 24 hours after midazolam admisnitration for each treatment period
AUC(0-inf) of midazolam following administration of midazolam alone and in combination with selexipag
AUC(0-inf) is the area under the plasma concentration-time curves of midazolam, calculated from time 0 (pre-dose) to the extrapolated infinite time
Measured: From pre-dose up to 24 hours after midazolam admisnitration for each treatment period
Secondary outcomes (5)
Cmax of 1-hydroxymidazolam following administration of midazolam alone and in combination with selexipag
Measured: From pre-dose up to 24 hours after midazolam admisnitration
AUC(0-inf) of 1-hydroxymidazolam following administration of midazolam alone and in combination with selexipag
Measured: From pre-dose up to 24 hours after midazolam admisnitration
tmax of midazolam and 1-hydroxymidazolam following administration of midazolam alone and in combination with selexipag
tmax is the time to reach Cmax of midazolam and its metabolite (1-hydroxymidazolam), respectively
Measured: From pre-dose up to 24 hours after midazolam admisnitration
t½ of midazolam and 1-hydroxymidazolam following administration of midazolam alone and in combination with selexipag.
t½ is the terminla half-life of midazolam and its metabolite (1-hydroxymidazolam), and corresponds to the period of time required for the concentration levels of midazolam and its metabolite to be reduced by one-half, respectively
Measured: From pre-dose up to 24 hours after midazolam admisnitration
Trough concentration of selexipag and its metabolite ACT-333679 at steady-state
Trough concentrations are measured before morning administration of selexipag
Measured: Days 1, 4, 7, 10,12 and 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 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
- Pierre-Eric Juif, PhD, Study director, Actelion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02791815
- Sponsor's protocol ID
- AC-065-114
- Other IDs
- 2016-000856-83, 2016
- Status last verified
- Oct 2016
- First submitted
- 2 Jun 2016
- Last updated
- 13 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open-label, Randomized, Two-treatment Crossover Study to Investigate the Effect of Selexipag on the Pharmacokinetics of Midazolam and Its Metabolite 1-hydroxymidazolam in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02791815
- Acronym / sponsor ID
- AC-065-114
- Conditions
- Healthy Subjects
- Keywords
- selexipag, pharmacokinetics, midazolam
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- ActelionIndustry (pharma, biotech, devices)
- Study start
- Jul 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 7 Jun 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.
The primary purpose of this study is to evaluate the effect of repeated doses of selexipag on the pharmacokinetics of a single oral dose of midazolam (i.e., how long and how much midazolam is present in the blood)
Detailed description
In order to exclude an inductive effect of selexipag in the gastrointestinal tract, this study aims at investigating the effect of selexipag on the PK of midazolam, a sensitive substrate of both hepatic and intestinal cytochrome P450 3A4 (CYP3A4).
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence AB | Experimental | Drug: Midazolam, Drug: SelexipagSubjects participate in two study periods: During the first period, they receive a single oral dose of midazolam on Day 1. During the second period, they receive oral selexipag alone from Day 1 to Day 11 and selexipag + midazolam on Day 12. There is a washout period of 14 to 21 days between the two periods. |
| Sequence BA | Experimental | Drug: Midazolam, Drug: SelexipagSubjects participate in two study periods: During the first period, they receive oral selexipag alone from Day 1 to Day 11 and selexipag + midazolam on Day 12. During the second period, they receive a single oral dose of midazolam on Day 1. There is a washout period of 14 to 21 days between the two periods. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Signed informed consent form
- Age from 18 to 45 years (inclusive) at screening
- Body mass index (BMI) from 18.0 to 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 |
|---|---|---|
| MidazolamSingle oral dose of 7.5 mg midazolam (tablet) | Drug | Sequence AB, Sequence BA |
| SelexipagAlso: ACT-293987Oral administration of selexipag (200 µg film-coated tablet) for 12 consecutive days (with a titration scheme from 400 to 1600 μg b.i.d. ) | Drug | Sequence AB, Sequence BA |
Primary outcome
Cmax of midazolam following administration of midazolam alone and in combination with selexipag
Time frame: From pre-dose up to 24 hours after midazolam admisnitration for each treatment period
Cmax is the maximum observed plasma concentration and is directly derived from the individual plasma concentration time curves of midazolam
AUC(0-inf) of midazolam following administration of midazolam alone and in combination with selexipag
Time frame: From pre-dose up to 24 hours after midazolam admisnitration for each treatment period
AUC(0-inf) is the area under the plasma concentration-time curves of midazolam, calculated from time 0 (pre-dose) to the extrapolated infinite time
5 secondary outcomes
Cmax of 1-hydroxymidazolam following administration of midazolam alone and in combination with selexipag
Time frame: From pre-dose up to 24 hours after midazolam admisnitration
AUC(0-inf) of 1-hydroxymidazolam following administration of midazolam alone and in combination with selexipag
Time frame: From pre-dose up to 24 hours after midazolam admisnitration
tmax of midazolam and 1-hydroxymidazolam following administration of midazolam alone and in combination with selexipag
Time frame: From pre-dose up to 24 hours after midazolam admisnitration
t½ of midazolam and 1-hydroxymidazolam following administration of midazolam alone and in combination with selexipag.
Time frame: From pre-dose up to 24 hours after midazolam admisnitration
Trough concentration of selexipag and its metabolite ACT-333679 at steady-state
Time frame: Days 1, 4, 7, 10,12 and 13
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 13 Oct 2016.
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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.
Pierre-Eric Juif, PhD study director
Actelion
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 Midazolam and Selexipag in people with Healthy Subjects, run by Actelion at 1 site in France.
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 13 Oct 2016. 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 France. 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?
Cmax of midazolam following administration of midazolam alone and in combination with selexipag (time frame: From pre-dose up to 24 hours after midazolam admisnitration 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?
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 13 Oct 2016; AzTrials last refreshed its copy on 8 Nov 2026.