Healthy SubjectsPhase 1NCT03100591
A Study to Evaluate ACT-132577 in Healthy Male Subjects
A Phase 1 study testing 14C-radiolabeled ACT-132577 in people with Healthy Subjects, run by Idorsia Pharmaceuticals Ltd. at 1 site in Netherlands.
Trial summary
The primary purpose of this study is to investigate the rate and routes (urine and feces) of elimination of ACT-132577, and the mass balance in urine and feces Read more about this study
- Who is it for?
- Ages 45 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- 14C-radiolabeled ACT-132577
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteNetherlands
- Study dates
- 28 Mar 2017to 18 Apr 2017
- 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 45 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed informed consent in a language understandable to the subject prior to any study-mandated procedure;
- Healthy male subjects aged between 45 and 65 years (inclusive) at screening;
- Body mass index of 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
- Values of hepatic aminotransferase (alanine aminotransferase and/or aspartate aminotransferase) > 3 × upper limit of normal range at screening;
- Hemoglobin < 100 g/L at screening;
- Known hypersensitivity to ACT-132577 or drugs of the same class, or any excipient of the ACT-132577 drug formulation;
- Known hypersensitivity or allergy to natural rubber latex;
- Previous exposure to ACT-132577;
- Treatment with another investigational drug within 3 months prior to screening or participation in more than 4 investigational drug studies within 1 year prior to screening;
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol;
- A radiation burden of > 0.1 milliSievert (mSv) and ≤ 1.0 mSv in the period of 1 year prior to screening; a radiation burden of ≥ 1.1 mSv and ≤ 2.0 mSv in the period of 2 years prior to screening, etc. (add 1 year per 1 mSv).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-center, Open-label Study With 14C-radiolabeled ACT-132577 to Investigate the Mass Balance, Pharmacokinetics, and Metabolism Following Single Oral Administration to Healthy Male Subjects
The primary purpose of this study is to investigate the rate and routes (urine and feces) of elimination of ACT-132577, and the mass balance in urine and feces
- Conditions
- Healthy Subjects
- Being tested
- 14C-radiolabeled ACT-132577
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
14C-radiolabeled ACT-132577Drug
Also called Aprocitentan
Single oral dose of 3.7 megabecquerel (MBq) (100 microcurie [μCi]) 14C-radiolabeled ACT-132577 administered as 1 capsule of 25 mg
| Study group | Role | What they receive |
|---|---|---|
| 14C-radiolabelled ACT-132577 | Experimental | On Day 1, subjects will receive a single oral dose of 25 mg 14C-radiolabeled ACT-132577, administered as an oral formulation in the fasted state Receives: Drug: 14C-radiolabeled ACT-132577 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative excretion of radioactivity in urine and feces
14C-radioactivity will be measured daily in urine and feces samples for determination of total radioactivity recovery
Measured: From study treatment administration up to day 15
Secondary outcomes (9)
Number of subjects with treatment-emergent adverse events and serious adverse events
Collection of any adverse event at each dose level
Measured: From study treatment administration up to day 32
Maximum plasma concentration (Cmax) of 14C-radiolabeled ACT-132577
Cmax is directly derived from the observed plasma concentrations of ACT-132577 and its metabolites
Measured: From study treatment administration up to day 15
Time to reach Cmax (tmax) of 14C-radiolabeled ACT-132577
tmax is directly derived from the observed plasma concentrations of ACT-132577 and its metabolites
Measured: From study treatment administration up to day 15
Terminal half-life (t1/2) of 14C-radiolabeled ACT-132577
t1/2 is calculated from the terminal rate constant obtained from the plasma concentrations-time curves of ACT-132577 and its metabolites
Measured: From study treatment administration up to day 15
Area under the plasma concentration-time curve (AUC) of 14C-radiolabeled ACT-132577
AUC is defined for the time intervals from zero to time t of the last measured concentration above the limit of quantification and from zero to infinity
Measured: From study treatment administration up to day 15
Maximum plasma concentration (Cmax) of ACT-132577 and its metabolites
Cmax is directly derived from the observed plasma concentrations of ACT-132577 and its metabolites
Measured: From study treatment administration up to day 15
Time to reach Cmax (tmax) of ACT-132577 and its metabolites
tmax is directly derived from the observed plasma concentrations of ACT-132577 and its metabolites
Measured: From study treatment administration up to day 15
Terminal half-life (t1/2) of ACT-132577 and its metabolites
t1/2 is calculated from the terminal rate constant obtained from the plasma concentrations-time curves of ACT-132577 and its metabolites
Measured: From study treatment administration up to day 15
Area under the plasma concentration-time curve (AUC) ACT-132577 and its metabolites
AUC is defined for the time intervals from zero to time t of the last measured concentration above the limit of quantification and from zero to infinity
Measured: From study treatment administration up to day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start28 Mar 2017
- Primary completion18 Apr 2017
- Study completion18 Apr 2017
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Idorsia Pharmaceuticals Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03100591
- Sponsor's protocol ID
- AC-080-104
- Status last verified
- Nov 2022
- First submitted
- 29 Mar 2017
- Last updated
- 29 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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
- Single-center, Open-label Study With 14C-radiolabeled ACT-132577 to Investigate the Mass Balance, Pharmacokinetics, and Metabolism Following Single Oral Administration to Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03100591
- Acronym / sponsor ID
- AC-080-104
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Mar 2017 (actual)
- Primary completion
- 18 Apr 2017 (actual)
- Study completion
- 18 Apr 2017 (actual)
- First posted
- 4 Apr 2017 (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 primary purpose of this study is to investigate the rate and routes (urine and feces) of elimination of ACT-132577, and the mass balance in urine and feces
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 14C-radiolabelled ACT-132577 | Experimental | Drug: 14C-radiolabeled ACT-132577On Day 1, subjects will receive a single oral dose of 25 mg 14C-radiolabeled ACT-132577, administered as an oral formulation in the fasted state |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed informed consent in a language understandable to the subject prior to any study-mandated procedure;
- Healthy male subjects aged between 45 and 65 years (inclusive) at screening;
- Body mass index of 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 (8 listed)
- Values of hepatic aminotransferase (alanine aminotransferase and/or aspartate aminotransferase) > 3 × upper limit of normal range at screening;
- Hemoglobin < 100 g/L at screening;
- Known hypersensitivity to ACT-132577 or drugs of the same class, or any excipient of the ACT-132577 drug formulation;
- Known hypersensitivity or allergy to natural rubber latex;
- Previous exposure to ACT-132577;
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 |
|---|---|---|
| 14C-radiolabeled ACT-132577Also: AprocitentanSingle oral dose of 3.7 megabecquerel (MBq) (100 microcurie [μCi]) 14C-radiolabeled ACT-132577 administered as 1 capsule of 25 mg | Drug | 14C-radiolabelled ACT-132577 |
Primary outcome
Cumulative excretion of radioactivity in urine and feces
Time frame: From study treatment administration up to day 15
14C-radioactivity will be measured daily in urine and feces samples for determination of total radioactivity recovery
9 secondary outcomes
Number of subjects with treatment-emergent adverse events and serious adverse events
Time frame: From study treatment administration up to day 32
Maximum plasma concentration (Cmax) of 14C-radiolabeled ACT-132577
Time frame: From study treatment administration up to day 15
Time to reach Cmax (tmax) of 14C-radiolabeled ACT-132577
Time frame: From study treatment administration up to day 15
Terminal half-life (t1/2) of 14C-radiolabeled ACT-132577
Time frame: From study treatment administration up to day 15
Area under the plasma concentration-time curve (AUC) of 14C-radiolabeled ACT-132577
Time frame: From study treatment administration up to day 15
Maximum plasma concentration (Cmax) of ACT-132577 and its metabolites
Time frame: From study treatment administration up to day 15
Time to reach Cmax (tmax) of ACT-132577 and its metabolites
Time frame: From study treatment administration up to day 15
Terminal half-life (t1/2) of ACT-132577 and its metabolites
Time frame: From study treatment administration up to day 15
Area under the plasma concentration-time curve (AUC) ACT-132577 and its metabolites
Time frame: From study treatment administration up to day 15
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.
Related trials for Healthy Subjects
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
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 Trials 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 14C-radiolabeled ACT-132577 in people with Healthy Subjects, run by Idorsia Pharmaceuticals Ltd. at 1 site in Netherlands.
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 8 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 Netherlands. 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?
Cumulative excretion of radioactivity in urine and feces (time frame: From study treatment administration up to day 15). 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.