Healthy SubjectsPhase 1NCT05196399
Bioequivalence Study of Different Aprocitentan Tablet Formulations
A Phase 1 study testing Aprocitentan (Formulation A) and Aprocitentan (Formulation B) in people with Healthy Subjects, run by Idorsia Pharmaceuticals Ltd. at 1 site in Czechia.
Trial summary
The main purpose is to study the pharmacokinetics of aprocitentan (ACT-132577) using 2 different tablet formulations. The clinical pharmacology data will be used to determine bioequivalence of 2 different tablet formulations. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Aprocitentan (Formulation A) and Aprocitentan (Formulation B)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteCzechia
- Study dates
- 2 Feb 2022to 7 Apr 2022
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed informed consent in a language understandable to the participant prior to any study-mandated procedure.
- Healthy male or female participant aged between 18 and 55 years (inclusive) at Screening.
- Body Mass Index of 18.0 to 30.0 kg/m2 (inclusive) at Screening.
- Systolic blood pressure (SBP) 100-140 mmHg, Diastolic blood pressure (DBP) 60-90 mmHg, and pulse rate 60-100 bpm (inclusive), measured on the dominant arm, after 5 min in the supine position at Screening and on Day 1 pre-dose of the first period.
- Woman of Childbearing Potential who has a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1 of the first period. She must agree to consistently and correctly use (from Screening, during the entire study, and for at least 30 days after the last study treatment administration) a highly effective method of contraception with a failure rate of less than 1% per year.
- Woman of non-childbearing potential, i.e., postmenopausal (defined as 12 consecutive months with no menses without an alternative medical cause; in addition, an FSH test must be performed at Screening to further support postmenopausal status), with previous bilateral salpingectomy, bilateral salpingo oophorectomy or hysterectomy, or with premature ovarian failure (confirmed by a specialist), XY genotype, uterine agenesis.
Who cannot join
- Pregnant or lactating woman.
- Previous administration of aprocitentan.
- Known hypersensitivity to endothelin receptor antagonists or to excipients used in any of the formulations.
- History of major medical or surgical disorders which, in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatments (appendectomy and herniotomy allowed, cholecystectomy not allowed).
- Acute, ongoing, recurrent, or chronic systemic disease able to interfere with the evaluation of the study results.
- Clinically relevant findings on the physical examination at Screening and on Day -1 of the first period.
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- Clinically relevant findings in clinical laboratory tests (hematology and clinical chemistry) at Screening and on Day -1 of the first period.
- Previous treatment with any prescribed medications (including vaccines) or over-the-counter medications (including herbal medicines such as St John's Wort, homeopathic preparations, vitamins, and minerals) within 3 weeks or 5 terminal elimination half-lives (t½; whichever is longer) prior to first study treatment administration.
- Legal incapacity or limited legal capacity at Screening.
- Positive COVID-19 test, if performed (subject to current epidemiological regulations in the Czech Republic) during the screening period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Open-label, Randomized, Two-way Crossover Phase 1 Study to Compare the Single-dose Pharmacokinetics of Different Tablet Formulations of Aprocitentan in Healthy Subjects
The main purpose is to study the pharmacokinetics of aprocitentan (ACT-132577) using 2 different tablet formulations. The clinical pharmacology data will be used to determine bioequivalence of 2 different tablet formulations.
- Conditions
- Healthy Subjects
- Being tested
- Aprocitentan (Formulation A), Aprocitentan (Formulation B)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aprocitentan (Formulation A)Drug
Also called ACT-132577
A single oral dose of 25 mg.
Aprocitentan (Formulation B)Drug
Also called ACT-132577
A single oral dose of 25 mg.
| Study group | Role | What they receive |
|---|---|---|
| Aprocitentan (reference product) | Experimental | 25 mg film-coated tablet Receives: Drug: Aprocitentan (Formulation A) |
| Aprocitentan (test product) | Experimental | 25 mg film-coated tablet Receives: Drug: Aprocitentan (Formulation B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax) of aprocitentan
Measured: Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 10.
The area under the plasma concentration-time curve from zero to time t of the last measured concentration above the limit of quantification (AUC0-t) of aprocitentan
Measured: Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 10.
Area under the plasma concentration-time curve from zero to infinity (AUC0-inf) of aprocitentan
Measured: Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 10.
Secondary outcomes (1)
Treatment-emergent adverse events
Measured: From study treatment administration on Day 1 up to last assessment at End of Period (Day 10).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start2 Feb 2022
- Primary completion27 Mar 2022
- Study completion7 Apr 2022
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
- None (open label)
- Enrolment
- 36 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
- NCT05196399
- Sponsor's protocol ID
- ID-080-110
- Other IDs
- 2021-005090-11
- Status last verified
- Nov 2022
- First submitted
- 5 Jan 2022
- Last updated
- 23 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open-label, Randomized, Two-way Crossover Phase 1 Study to Compare the Single-dose Pharmacokinetics of Different Tablet Formulations of Aprocitentan in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05196399
- Acronym / sponsor ID
- ID-080-110
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 27 Mar 2022 (actual)
- Study completion
- 7 Apr 2022 (actual)
- First posted
- 19 Jan 2022 (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 main purpose is to study the pharmacokinetics of aprocitentan (ACT-132577) using 2 different tablet formulations. The clinical pharmacology data will be used to determine bioequivalence of 2 different tablet formulations.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aprocitentan (reference product) | Experimental | Drug: Aprocitentan (Formulation A)25 mg film-coated tablet |
| Aprocitentan (test product) | Experimental | Drug: Aprocitentan (Formulation B)25 mg film-coated tablet |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Signed informed consent in a language understandable to the participant prior to any study-mandated procedure.
- Healthy male or female participant aged between 18 and 55 years (inclusive) at Screening.
- Body Mass Index of 18.0 to 30.0 kg/m2 (inclusive) at Screening.
- Systolic blood pressure (SBP) 100-140 mmHg, Diastolic blood pressure (DBP) 60-90 mmHg, and pulse rate 60-100 bpm (inclusive), measured on the dominant arm, after 5 min in the supine position at Screening and on Day 1 pre-dose of the first period.
- Woman of Childbearing Potential who has a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1 of the first period. She must agree to consistently and correctly use (from Screening, during the entire study, and for at least 30 days after the last study treatment administration) a highly effective method of contraception with a failure rate of less than 1% per year.
Key exclusion criteria (10 listed)
- Pregnant or lactating woman.
- Previous administration of aprocitentan.
- Known hypersensitivity to endothelin receptor antagonists or to excipients used in any of the formulations.
- History of major medical or surgical disorders which, in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatments (appendectomy and herniotomy allowed, cholecystectomy not allowed).
- Acute, ongoing, recurrent, or chronic systemic disease able to interfere with the evaluation of the study results.
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 |
|---|---|---|
| Aprocitentan (Formulation A)Also: ACT-132577A single oral dose of 25 mg. | Drug | Aprocitentan (reference product) |
| Aprocitentan (Formulation B)Also: ACT-132577A single oral dose of 25 mg. | Drug | Aprocitentan (test product) |
Primary outcome
Maximum plasma concentration (Cmax) of aprocitentan
Time frame: Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 10.
The area under the plasma concentration-time curve from zero to time t of the last measured concentration above the limit of quantification (AUC0-t) of aprocitentan
Time frame: Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 10.
Area under the plasma concentration-time curve from zero to infinity (AUC0-inf) of aprocitentan
Time frame: Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 10.
1 secondary outcome
Treatment-emergent adverse events
Time frame: From study treatment administration on Day 1 up to last assessment at End of Period (Day 10).
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 23 Nov 2022.
- Individual participant dataSharing planned: No
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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 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 Aprocitentan (Formulation A) and Aprocitentan (Formulation B) in people with Healthy Subjects, run by Idorsia Pharmaceuticals Ltd. at 1 site in Czechia.
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 6 inclusion and 10 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 23 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 Czechia. 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 plasma concentration (Cmax) of aprocitentan (time frame: Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 10.). The study lists 3 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 23 Nov 2022.