Severe Renal ImpairmentPhase 1NCT03165071
A Study to Evaluate ACT-132577 in Healthy Subjects and in People With Severe Kidney Disease
A Phase 1 study testing ACT-132577 in people with Severe Renal Impairment and Healthy Subjects, run by Idorsia Pharmaceuticals Ltd. at 1 site in Czechia.
Trial summary
The primary purpose of this study is to investigate the fate of ACT-132577 in healthy subjects and in people with severe kidney disease Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Severe Renal Impairment, Healthy Subjects
- What is being tested?
- ACT-132577
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCzechia
- Study dates
- 3 Jun 2017to 27 Oct 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ALL SUBJECTS:
- Signed informed consent in the local language prior to any study-mandated procedure;
- Male/female aged 18 to 65 years (inclusive) at screening;
- Body mass index of 18.0 to 32.0 kg/m2 (inclusive) at screening. Body weight at least 50 kg;
- Women of childbearing potential must have a negative serum pregnancy test and use reliable birth controls up to 30 days after the end of study treatment.
- HEALTHY SUBJECTS:
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- Normal renal function confirmed by the estimated glomerular filtration rate (eGFR) determined at screening;
- Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests.
- SEVERE RENAL FUNCTION IMPAIRMENT SUBJECTS:
- Severe renal function impairment is defined by eGFR estimated at screening between 15 mL/min/1.73 m2 and 29 mL/min/1.73 m2 (inclusive).
Who cannot join
- ALL SUBJECTS:
- Pregnant or lactating women;
- Known hypersensitivity to ACT-132577 or drugs of the same class, or any of their excipients;
- Known hypersensitivity or allergy to natural rubber latex;
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
- SEVERE RENAL FUNCTION IMPAIRMENT SUBJECTS:
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- End-stage renal disease that requires dialysis;
- Hemoglobin concentration < 9 g/dL;
- History of severe renal stenosis;
- Serum potassium concentration > 5.5 mmol/L;
- Presence of severe cardiac disease;
- History of clinically relevant bleeding disorder;
- Presence of any organ disorder, with the exception of renal function impairment, or use of any medication which might interfere with the pharmacokinetics of ACT-132577;
- Known life-threatening disease with a life expectancy of less than 1 year;
- Presence of unstable diabetes mellitus.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Open Label, Single-dose Study to Investigate the Effect of Severe Renal Impairment on the Pharmacokinetics of ACT-132577
The primary purpose of this study is to investigate the fate of ACT-132577 in healthy subjects and in people with severe kidney disease
- Conditions
- Severe Renal Impairment, Healthy Subjects
- Being tested
- ACT-132577
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT-132577Drug
Also called Aprocitentan
Capsule
| Study group | Role | What they receive |
|---|---|---|
| ACT-132577 (50 mg) | Experimental | 8 healthy subjects and 8 subjects with severe renal function impairment will receive a single oral dose of 50 mg ACT-132577 administered as capsule following an overnight fast Receives: Drug: ACT-132577 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax) of ACT-132577
Cmax of ACT-132577 will be derived by non-compartmental analysis of the plasma concentration-time profiles
Measured: From baseline to up to 16 days
Area under the plasma concentration-time curves during a dosing interval [AUC(0-t)] of ACT-132577
AUC(0-T) of ACT-132577 will be derived by non-compartmental analysis of the plasma concentration-time profiles
Measured: From baseline to up to 16 days
Area under the plasma concentration-time curves from time 0 to inf [AUC(0-inf)]
AUC(0-inf) of ACT-132577 will be derived by non-compartmental analysis of the plasma concentration-time profiles
Measured: From baseline to up to 16 days
Secondary outcomes (5)
Time to reach Cmax (tmax) of ACT-132577
tmax of ACT-132577 will be derived by non-compartmental analysis of the plasma concentration-time profiles
Measured: From baseline to up to 16 days
Terminal half-life [t(1/2)]
t1/2 of ACT-132577 will be derived by non-compartmental analysis of the plasma concentration-time profiles
Measured: From baseline to up to 16 days
Incidence of treatment-emergent adverse events
The percentage of subjects with treatment-emergent adverse events will be reported
Measured: From baseline to up to 16 days
Incidence of adverse events leading to premature discontinuation of study treatment
The number of subjects who prematurely discontinued the study treatment due to an adverse event will be reported
Measured: From baseline to up to 16 days
Incidence of any clinical relevant findings in ECG variables
The number of subjects with any treatment-emergent electrocardiogram (ECG) abnormalities will be reported
Measured: From baseline to up to 16 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study start3 Jun 2017
- Primary completion27 Oct 2017
- Study completion27 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe Renal ImpairmentStudies 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
- 16 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
- NCT03165071
- Sponsor's protocol ID
- AC-080-105
- Other IDs
- 2016-005077-12, 2016
- Status last verified
- Nov 2022
- First submitted
- 23 May 2017
- Last updated
- 23 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sidharta PN, Ulc I, Dingemanse J. Single-Dose Pharmacokinetics and Tolerability of Aprocitentan, a Dual Endothelin Receptor Antagonist, in Subjects with Severe Renal Function Impairment. Clin Drug Investig. 2019 Nov;39(11):1117-1123. doi: 10.1007/s40261-019-00837-x.
PubMed 31435905
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, Single-dose Study to Investigate the Effect of Severe Renal Impairment on the Pharmacokinetics of ACT-132577
- ClinicalTrials.gov ID
- NCT03165071
- Acronym / sponsor ID
- AC-080-105
- Conditions
- Severe Renal Impairment, Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Jun 2017 (actual)
- Primary completion
- 27 Oct 2017 (actual)
- Study completion
- 27 Oct 2017 (actual)
- First posted
- 24 May 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 fate of ACT-132577 in healthy subjects and in people with severe kidney disease
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACT-132577 (50 mg) | Experimental | Drug: ACT-1325778 healthy subjects and 8 subjects with severe renal function impairment will receive a single oral dose of 50 mg ACT-132577 administered as capsule following an overnight fast |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed informed consent in the local language prior to any study-mandated procedure;
- Male/female aged 18 to 65 years (inclusive) at screening;
- Body mass index of 18.0 to 32.0 kg/m2 (inclusive) at screening. Body weight at least 50 kg;
- Women of childbearing potential must have a negative serum pregnancy test and use reliable birth controls up to 30 days after the end of study treatment.
- Normal renal function confirmed by the estimated glomerular filtration rate (eGFR) determined at screening;
Key exclusion criteria (15 listed)
- Pregnant or lactating women;
- Known hypersensitivity to ACT-132577 or drugs of the same class, or any of their excipients;
- Known hypersensitivity or allergy to natural rubber latex;
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
- End-stage renal disease that requires dialysis;
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 |
|---|---|---|
| ACT-132577Also: AprocitentanCapsule | Drug | ACT-132577 (50 mg) |
Primary outcome
Maximum plasma concentration (Cmax) of ACT-132577
Time frame: From baseline to up to 16 days
Cmax of ACT-132577 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 ACT-132577
Time frame: From baseline to up to 16 days
AUC(0-T) of ACT-132577 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)]
Time frame: From baseline to up to 16 days
AUC(0-inf) of ACT-132577 will be derived by non-compartmental analysis of the plasma concentration-time profiles
5 secondary outcomes
Time to reach Cmax (tmax) of ACT-132577
Time frame: From baseline to up to 16 days
Terminal half-life [t(1/2)]
Time frame: From baseline to up to 16 days
Incidence of treatment-emergent adverse events
Time frame: From baseline to up to 16 days
Incidence of adverse events leading to premature discontinuation of study treatment
Time frame: From baseline to up to 16 days
Incidence of any clinical relevant findings in ECG variables
Time frame: From baseline to up to 16 days
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.
- Background: PubMed 31435905Sidharta PN, Ulc I, Dingemanse J. Single-Dose Pharmacokinetics and Tolerability of Aprocitentan, a Dual Endothelin Receptor Antagonist, in Subjects with Severe Renal Function Impairment. Clin Drug Investig. 2019 Nov;39(11):1117-1123. doi: 10.1007/s40261-019-00837-x.
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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 ACT-132577 in people with Severe Renal Impairment and 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 10 inclusion and 15 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 ACT-132577 (time frame: From baseline to up to 16 days). 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?
On the ClinicalTrials.gov record for NCT03165071, which also lists 1 linked publication.
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.