Healthy SubjectsPhase 1NCT03586570
A Study to Evaluate How Aprocitentan is Safe and How it is Absorbed and Broken Down in the Body of Japanese and Caucasian Subjects
A Phase 1 study testing Aprocitentan 25mg in people with Healthy Subjects, run by Idorsia Pharmaceuticals Ltd. at 1 site in United States.
Trial summary
The objective of this study is to evaluate the tolerability, safety, and pharmacokinetics after multiple-dose administration of aprocitentan (25 mg) in healthy Japanese and Caucasian subjects. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Aprocitentan 25mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2018to 10 Sep 2018
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must be of Caucasian or Japanese ethnicity
- Signed informed consent in a language understandable to the subject prior to any study-mandated procedure
- Body mass index (BMI) of 18.0 to 28.0 kg/m2 (inclusive) at Screening
- Systolic blood pressure 100-145 mmHg, diastolic blood pressure 50-90 mmHg, and pulse rate 45-90 bpm (inclusive), measured on the same arm, after 5 min in the supine position at Screening
- A woman of childbearing potential is eligible only if the following applies:
- Negative serum pregnancy test at Screening,
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- Negative urine pregnancy test on Day -1,
- Agreement to consistently and correctly use a reliable method of contraception from Screening up to at least 30 days after last study treatment administration
- Japanese subjects only
- Subjects must be of native Japanese descent (all parents/grandparents of Japanese descent).
- Subjects must not have been away from Japan for more than 10 years (at Screening visit).
- Subject's lifestyle should not have changed significantly since relocation from Japan
Who cannot join
- Previous exposure to aprocitentan and/or macitentan.
- Known hypersensitivity to aprocitentan or treatments of the same class, or any of the excipients
- Pregnant or lactating women
- 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, Placebo-controlled, Randomized Study to Investigate the Tolerability, Safety, and Pharmacokinetics After Multiple-dose Administration of 25 mg Aprocitentan in Healthy Japanese and Caucasian Subjects
The objective of this study is to evaluate the tolerability, safety, and pharmacokinetics after multiple-dose administration of aprocitentan (25 mg) in healthy Japanese and Caucasian subjects.
- Conditions
- Healthy Subjects
- Being tested
- Aprocitentan 25mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aprocitentan 25mgDrug
Oral tablets in strength of 25 mg
PlaceboDrug
Oral tablets matching aprocitentan tablets
| Study group | Role | What they receive |
|---|---|---|
| Aprocitentan | Experimental | Not described Receives: Drug: Aprocitentan 25mg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax during the first and last dosing interval
Measured: From study treatment administration to 216 hours after last administration
Time to reach Cmax (tmax) during the first and last dosing interval
Measured: From study treatment administration to 216 hours after last administration
AUCτ on the first and last day of study treatment intake
Measured: From study treatment administration to 216 hours after last administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2018
- Study start17 Jul 2018
- Primary completion10 Sep 2018
- Study completion10 Sep 2018
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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Janssen Biotech, Inc.
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Idorsia Pharmaceuticals Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03586570
- Sponsor's protocol ID
- ID-080-107
- Status last verified
- Nov 2022
- First submitted
- 2 Jul 2018
- Last updated
- 23 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- 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, Double-blind, Placebo-controlled, Randomized Study to Investigate the Tolerability, Safety, and Pharmacokinetics After Multiple-dose Administration of 25 mg Aprocitentan in Healthy Japanese and Caucasian Subjects
- ClinicalTrials.gov ID
- NCT03586570
- Acronym / sponsor ID
- ID-080-107
- 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)
- Collaborators
- Janssen Biotech, Inc.
- Study start
- 17 Jul 2018 (actual)
- Primary completion
- 10 Sep 2018 (actual)
- Study completion
- 10 Sep 2018 (actual)
- First posted
- 13 Jul 2018 (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 objective of this study is to evaluate the tolerability, safety, and pharmacokinetics after multiple-dose administration of aprocitentan (25 mg) in healthy Japanese and Caucasian subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aprocitentan | Experimental | Drug: Aprocitentan 25mg |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Subjects must be of Caucasian or Japanese ethnicity
- Signed informed consent in a language understandable to the subject prior to any study-mandated procedure
- Body mass index (BMI) of 18.0 to 28.0 kg/m2 (inclusive) at Screening
- Systolic blood pressure 100-145 mmHg, diastolic blood pressure 50-90 mmHg, and pulse rate 45-90 bpm (inclusive), measured on the same arm, after 5 min in the supine position at Screening
- A woman of childbearing potential is eligible only if the following applies:
Key exclusion criteria (4 listed)
- Previous exposure to aprocitentan and/or macitentan.
- Known hypersensitivity to aprocitentan or treatments of the same class, or any of the excipients
- Pregnant or lactating women
- 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 |
|---|---|---|
| Aprocitentan 25mgOral tablets in strength of 25 mg | Drug | Aprocitentan |
| PlaceboOral tablets matching aprocitentan tablets | Drug | Placebo |
Primary outcome
Cmax during the first and last dosing interval
Time frame: From study treatment administration to 216 hours after last administration
Time to reach Cmax (tmax) during the first and last dosing interval
Time frame: From study treatment administration to 216 hours after last administration
AUCτ on the first and last day of study treatment intake
Time frame: From study treatment administration to 216 hours after last administration
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.
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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 25mg 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 12 inclusion and 4 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 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. 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?
Cmax during the first and last dosing interval (time frame: From study treatment administration to 216 hours after last administration). 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.