Healthy SubjectsPhase 1NCT03245229
A Study in Healthy Male Subjects to Investigate Whether Administration of ACT-132577 Can Affect Rosuvastatin's Fate in the Body (Amount and Time of Presence in the Blood)
A Phase 1 study testing Aprocitentan and Rosuvastatin in people with Healthy Subjects, run by Idorsia Pharmaceuticals Ltd. at 1 site in Czechia.
Trial summary
The primary purpose of this study is to investigate the effect of Aprocitentan (ACT-132577) at steady state on the pharmacokinetics of single-dose rosuvastatin in healthy male 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 and Rosuvastatin
- 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 siteCzechia
- Study dates
- 10 Aug 2017to 18 Sep 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 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;
- Healthy male subjects aged 18 to 45 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;
- Hemoglobin ≥ 135 g/L at screening.
Who cannot join
- Known allergic reactions or hypersensitivity to ACT-132577, rosuvastatin, any drug of the same classes, or any of their excipients;
- Any contraindication for rosuvastatin treatment;
- History or clinical evidence of myopathy;
- Asian or Indian-Asian ethnicity;
- Known hypersensitivity or allergy to natural rubber latex;
- Previous exposure to ACT-132577;
- Treatment with rosuvastatin within 3 months 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Open-label, One-sequence, Two-treatment Study to Investigate the Effect of ACT-132577 at Steady State on the Pharmacokinetics of Rosuvastatin in Healthy Male Subjects
The primary purpose of this study is to investigate the effect of Aprocitentan (ACT-132577) at steady state on the pharmacokinetics of single-dose rosuvastatin in healthy male subjects
- Conditions
- Healthy Subjects
- Being tested
- Aprocitentan, Rosuvastatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AprocitentanDrug
Also called ACT-132577
Capsule for oral administration
RosuvastatinDrug
Tablet for oral administration
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | In the morning of Day 1, a single dose of 10 mg rosuvastatin will be administered in the fasted state followed by an observation period of 96 h Receives: Drug: Rosuvastatin |
| Treatment B1 | Experimental | 25 mg ACT-132577 will be administered o.d. from Day 5 to Day 12 Receives: Drug: Aprocitentan |
| Treatment B2 | Experimental | In the morning of Day 13, a single dose of 10 mg rosuvastatin will be administered in the fasted state, concomitantly with 25 mg ACT-132577, followed by an observation period of 120 h.
Doses of 25 mg ACT-132577 will be administered o.d. from Day 14 to Day 17. Receives: Drug: Aprocitentan; Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax) of rosuvastatin
Cmax of rosuvastatin will be derived by non-compartmental analysis of the plasma concentration-time profiles
Measured: Up to Day 29
Time to reach Cmax (tmax) of rosuvastatin
tmax of rosuvastatin will be derived by non-compartmental analysis of the plasma concentration-time profiles
Measured: Up to Day 29
Terminal half-life (t1/2) of rosuvastatin
t1/2 of rosuvastatin will be derived by non-compartmental analysis of the plasma concentration-time profiles
Measured: Up to Day 29
Area under the plasma concentration-time curves during a dosing interval [AUC(0-t)] of rosuvastatin
AUC(0-t) of rosuvastatin will be derived by non-compartmental analysis of the plasma concentration-time profiles
Measured: Up to Day 29
Area under the plasma concentration-time curves from time 0 to inf [AUC(0-inf)] of rosuvastatin
AUC(0-inf) of rosuvastatin will be derived by non-compartmental analysis of the plasma concentration-time profile
Measured: Up to Day 29
Trough (pre-dose) plasma concentrations (Ctrough) of ACT-132577
Ctrough of ACT-132577 will be derived by non-compartmental analysis of the plasma concentration-time profile
Measured: Up to Day 29
Secondary outcomes (4)
Number of participants with adverse events (AEs)
Treatment emergent adverse events and treatment emergent serious adverse events will be evaluated throughout the study
Measured: Up to Day 29
Changes from baseline in electrocardiogram (ECG) variables
ECG variables are to be recorded at rest using a standard 12-lead ECG
Measured: Up to Day 29
Changes from baseline in blood pressure
Blood pressure (mmHg) measured using an automatic oscillometric device
Measured: Up to Day 29
Changes from baseline in pulse rate
Pulse rate (bpm) measured using an automatic oscillometric device
Measured: Up to Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2017
- Study start10 Aug 2017
- Primary completion18 Sep 2017
- Study completion18 Sep 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
- Non-randomised
- Intervention model
- Single group
- 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
- NCT03245229
- Sponsor's protocol ID
- AC-080-106
- Status last verified
- Nov 2022
- First submitted
- 8 Aug 2017
- Last updated
- 29 Nov 2022
- Results posted
- No
- Data monitoring committee
- 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
- A Single-center, Open-label, One-sequence, Two-treatment Study to Investigate the Effect of ACT-132577 at Steady State on the Pharmacokinetics of Rosuvastatin in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03245229
- Acronym / sponsor ID
- AC-080-106
- 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
- 10 Aug 2017 (actual)
- Primary completion
- 18 Sep 2017 (actual)
- Study completion
- 18 Sep 2017 (actual)
- First posted
- 10 Aug 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 effect of Aprocitentan (ACT-132577) at steady state on the pharmacokinetics of single-dose rosuvastatin in healthy male subjects
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: RosuvastatinIn the morning of Day 1, a single dose of 10 mg rosuvastatin will be administered in the fasted state followed by an observation period of 96 h |
| Treatment B1 | Experimental | Drug: Aprocitentan25 mg ACT-132577 will be administered o.d. from Day 5 to Day 12 |
| Treatment B2 | Experimental | Drug: Aprocitentan, Drug: RosuvastatinIn the morning of Day 13, a single dose of 10 mg rosuvastatin will be administered in the fasted state, concomitantly with 25 mg ACT-132577, followed by an observation period of 120 h. Doses of 25 mg ACT-132577 will be administered o.d. from Day 14 to Day 17. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Signed informed consent in the local language prior to any study mandated procedure;
- Healthy male subjects aged 18 to 45 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;
- Hemoglobin ≥ 135 g/L at screening.
Key exclusion criteria (8 listed)
- Known allergic reactions or hypersensitivity to ACT-132577, rosuvastatin, any drug of the same classes, or any of their excipients;
- Any contraindication for rosuvastatin treatment;
- History or clinical evidence of myopathy;
- Asian or Indian-Asian ethnicity;
- Known hypersensitivity or allergy to natural rubber latex;
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-132577Capsule for oral administration | Drug | Treatment B1, Treatment B2 |
| RosuvastatinTablet for oral administration | Drug | Treatment A, Treatment B2 |
Primary outcome
Maximum plasma concentration (Cmax) of rosuvastatin
Time frame: Up to Day 29
Cmax of rosuvastatin will be derived by non-compartmental analysis of the plasma concentration-time profiles
Time to reach Cmax (tmax) of rosuvastatin
Time frame: Up to Day 29
tmax of rosuvastatin will be derived by non-compartmental analysis of the plasma concentration-time profiles
Terminal half-life (t1/2) of rosuvastatin
Time frame: Up to Day 29
t1/2 of rosuvastatin will be derived by non-compartmental analysis of the plasma concentration-time profiles
Area under the plasma concentration-time curves during a dosing interval [AUC(0-t)] of rosuvastatin
Time frame: Up to Day 29
AUC(0-t) of rosuvastatin will be derived by non-compartmental analysis of the plasma concentration-time profiles
Area under the plasma concentration-time curves from time 0 to inf [AUC(0-inf)] of rosuvastatin
Time frame: Up to Day 29
AUC(0-inf) of rosuvastatin will be derived by non-compartmental analysis of the plasma concentration-time profile
Trough (pre-dose) plasma concentrations (Ctrough) of ACT-132577
Time frame: Up to Day 29
Ctrough of ACT-132577 will be derived by non-compartmental analysis of the plasma concentration-time profile
4 secondary outcomes
Number of participants with adverse events (AEs)
Time frame: Up to Day 29
Changes from baseline in electrocardiogram (ECG) variables
Time frame: Up to Day 29
Changes from baseline in blood pressure
Time frame: Up to Day 29
Changes from baseline in pulse rate
Time frame: Up to Day 29
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 and Rosuvastatin 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 5 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 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 rosuvastatin (time frame: Up to Day 29). The study lists 6 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.