Healthy SubjectsPhase 1NCT02708004
Clinical Study to Assess Body Fluid Homeostasis After Administration of ACT-132577 in Healthy Subjects
A Phase 1 study testing Aprocitentan in people with Healthy Subjects, run by Idorsia Pharmaceuticals Ltd. at 1 site in Switzerland.
Trial summary
This clinical study will be conducted to evaluate the effect of ACT-132577 on fluid homeostasis in healthy subjects. 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?
- Aprocitentan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2016to 1 Dec 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
- Healthy on the basis of medical history, physical examination, cardiovascular assessments and hematology, clinical chemistry, and urinalysis tests
- Body mass index between 20.0 and 25.0 kg/m2 (inclusive) at screening
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, Double-blind, Randomized, Placebo-controlled, Two-way Crossover Study to Assess Body Fluid Homeostasis After Administration of ACT-132577 in Healthy Subjects
This clinical study will be conducted to evaluate the effect of ACT-132577 on fluid homeostasis in healthy subjects.
- Conditions
- Healthy Subjects
- Being tested
- Aprocitentan, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AprocitentanDrug
Also called ACT-132577
Formulated in capsules in 2 different strengths; 2 capsules per day
PlaceboOther
Matching active drug
| Study group | Role | What they receive |
|---|---|---|
| ACT-132577 | Experimental | 3 different dose levels Receives: Drug: Aprocitentan |
| Placebo | Placebo comparator | Matching active drug Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Change from baseline
Measured: from Day 1 to Day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study start1 Jun 2016
- Primary completion1 Dec 2016
- Study completion1 Dec 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
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 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
- NCT02708004
- Sponsor's protocol ID
- AC-080-102
- Status last verified
- Nov 2022
- First submitted
- 24 Feb 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, Double-blind, Randomized, Placebo-controlled, Two-way Crossover Study to Assess Body Fluid Homeostasis After Administration of ACT-132577 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02708004
- Acronym / sponsor ID
- AC-080-102
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2016
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 15 Mar 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.
This clinical study will be conducted to evaluate the effect of ACT-132577 on fluid homeostasis in healthy subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACT-132577 | Experimental | Drug: Aprocitentan3 different dose levels |
| Placebo | Placebo comparator | Other: PlaceboMatching active drug |
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
- Healthy on the basis of medical history, physical examination, cardiovascular assessments and hematology, clinical chemistry, and urinalysis tests
- Body mass index between 20.0 and 25.0 kg/m2 (inclusive) at screening
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 |
|---|---|---|
| AprocitentanAlso: ACT-132577Formulated in capsules in 2 different strengths; 2 capsules per day | Drug | ACT-132577 |
| PlaceboMatching active drug | Other | Placebo |
Primary outcome
Body weight
Time frame: from Day 1 to Day 9
Change from baseline
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 Aprocitentan in people with Healthy Subjects, run by Idorsia Pharmaceuticals Ltd. at 1 site in Switzerland.
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 Switzerland. 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. Some participants in this study may receive a placebo. 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?
Body weight (time frame: from Day 1 to Day 9). 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.