Healthy SubjectsPhase 1NCT02841761
A Study to Investigate the Effect of ACT-132577 on the Pharmacokinetics of Midazolam and 1-hydroxy Midazolam in Healthy Male Subjects
A Phase 1 study testing Midalozam and Aprocitentan in people with Healthy Subjects, run by Idorsia Pharmaceuticals Ltd. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effect of ACT-132577 on the pharmacokinetics of midazolam and 1-hydroxy midazolam and to evaluate the safety and tolerability of ACT-132577 when administered alone and in combination with midazolam. 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?
- Midalozam and Aprocitentan
- 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 siteUnited States
- Study dates
- 1 Jul 2016to 1 Oct 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 in the local language prior to any study-mandated procedure
- Body mass index (BMI) of 18.0 to 30.0 kg/m2 (inclusive) at screening
- Healthy on the basis of medical history, physical examination, cardiovascular assessments and serology and laboratory tests
Who cannot join
- Any circumstances or conditions, which, in the opinion of the investigator, may affect 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, Two-treatment Study to Investigate the Effect of ACT-132577 at Steady State on the Pharmacokinetics of Midazolam and Its Metabolite 1-hydroxy Midazolam in Healthy Male Subjects
The purpose of this study is to evaluate the effect of ACT-132577 on the pharmacokinetics of midazolam and 1-hydroxy midazolam and to evaluate the safety and tolerability of ACT-132577 when administered alone and in combination with midazolam.
- Conditions
- Healthy Subjects
- Being tested
- Midalozam, Aprocitentan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidalozamDrug
Syrup for oral use
AprocitentanDrug
Also called ACT-132577
Capsules for oral use
| Study group | Role | What they receive |
|---|---|---|
| Treatment A (Midazolam) | Experimental | Single dose of Midazolam 8 mg on Day 1 Receives: Drug: Midalozam |
| Treatment B1 (ACT-132577) | Experimental | Single dose of ACT-132577 150 mg on Day 2; single dose of ACT-132577 50 mg on Day 3, Day 4, and Day 5. Receives: Drug: Aprocitentan |
| Treatment B2 (Midazolam + ACT-132577) | Experimental | Single dose of Midazolam 8 mg and single dose of ACT-132577 50 mg on Day 6 Receives: Drug: Midalozam; Drug: Aprocitentan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plama concentration (Cmax)
Cmax of midazolam and 1-hydroxy midazolam following administration of midazolam alone and in combination with ACT-132577
Measured: Midazolam PK sampling on Days 1, 2, 6 and 7
Area under the plasma concentration-time curve from zero to infinity (AUC0-∞)
AUC0-∞ of midazolam and 1-hydroxy midazolam following administration of midazolam alone and in combination with ACT-132577
Measured: Midazolam PK sampling on Days 1, 2, 6 and 7
Time to reach Cmax (tmax)
Tmax of midazolam and 1-hydroxy midazolam following administration of midazolam alone and in combination with ACT-132577
Measured: Midazolam PK sampling on Days 1, 2, 6 and 7
Terminal half-life (t1/2)
T1/2 of midazolam and 1-hydroxy midazolam following administration of midazolam alone and in combination with ACT-132577
Measured: Midazolam PK sampling on Days 1, 2, 6 and 7
Secondary outcomes (2)
Number of subjects with adverse events
Measured: From Day 1 to Follow-up (for up to 38 days)
Number of subjects with serious adverse events
Measured: From Screening to Follow-up (for up to 59 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study start1 Jul 2016
- Primary completion1 Sep 2016
- Study completion1 Oct 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
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial, Study director, Idorsia Pharmaceuticals Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02841761
- Sponsor's protocol ID
- AC-080-103
- Status last verified
- Nov 2022
- First submitted
- 20 Jul 2016
- Last updated
- 29 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open-label, Two-treatment Study to Investigate the Effect of ACT-132577 at Steady State on the Pharmacokinetics of Midazolam and Its Metabolite 1-hydroxy Midazolam in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02841761
- Acronym / sponsor ID
- AC-080-103
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2016
- Primary completion
- 1 Sep 2016 (actual)
- Study completion
- 1 Oct 2016 (actual)
- First posted
- 22 Jul 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 purpose of this study is to evaluate the effect of ACT-132577 on the pharmacokinetics of midazolam and 1-hydroxy midazolam and to evaluate the safety and tolerability of ACT-132577 when administered alone and in combination with midazolam.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A (Midazolam) | Experimental | Drug: MidalozamSingle dose of Midazolam 8 mg on Day 1 |
| Treatment B1 (ACT-132577) | Experimental | Drug: AprocitentanSingle dose of ACT-132577 150 mg on Day 2; single dose of ACT-132577 50 mg on Day 3, Day 4, and Day 5. |
| Treatment B2 (Midazolam + ACT-132577) | Experimental | Drug: Midalozam, Drug: AprocitentanSingle dose of Midazolam 8 mg and single dose of ACT-132577 50 mg on Day 6 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Signed informed consent in the local language prior to any study-mandated procedure
- Body mass index (BMI) of 18.0 to 30.0 kg/m2 (inclusive) at screening
- Healthy on the basis of medical history, physical examination, cardiovascular assessments and serology and laboratory tests
Key exclusion criteria (1 listed)
- Any circumstances or conditions, which, in the opinion of the investigator, may affect 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 |
|---|---|---|
| MidalozamSyrup for oral use | Drug | Treatment A (Midazolam), Treatment B2 (Midazolam + ACT-132577) |
| AprocitentanAlso: ACT-132577Capsules for oral use | Drug | Treatment B1 (ACT-132577), Treatment B2 (Midazolam + ACT-132577) |
Primary outcome
Maximum observed plama concentration (Cmax)
Time frame: Midazolam PK sampling on Days 1, 2, 6 and 7
Cmax of midazolam and 1-hydroxy midazolam following administration of midazolam alone and in combination with ACT-132577
Area under the plasma concentration-time curve from zero to infinity (AUC0-∞)
Time frame: Midazolam PK sampling on Days 1, 2, 6 and 7
AUC0-∞ of midazolam and 1-hydroxy midazolam following administration of midazolam alone and in combination with ACT-132577
Time to reach Cmax (tmax)
Time frame: Midazolam PK sampling on Days 1, 2, 6 and 7
Tmax of midazolam and 1-hydroxy midazolam following administration of midazolam alone and in combination with ACT-132577
Terminal half-life (t1/2)
Time frame: Midazolam PK sampling on Days 1, 2, 6 and 7
T1/2 of midazolam and 1-hydroxy midazolam following administration of midazolam alone and in combination with ACT-132577
2 secondary outcomes
Number of subjects with adverse events
Time frame: From Day 1 to Follow-up (for up to 38 days)
Number of subjects with serious adverse events
Time frame: From Screening to Follow-up (for up to 59 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 29 Nov 2022.
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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.
Clinical Trial study director
Idorsia Pharmaceuticals Ltd.
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 Midalozam and Aprocitentan in people with Healthy Subjects, run by Idorsia Pharmaceuticals Ltd. at 1 site in United States.
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 3 inclusion and 1 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 29 Nov 2022. 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 United States. 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 plama concentration (Cmax) (time frame: Midazolam PK sampling on Days 1, 2, 6 and 7). 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 29 Nov 2022.