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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-005077-12 | EudraCT Number |
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The primary purpose of this study is to investigate the fate of ACT-132577 in healthy subjects and in people with severe kidney disease
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACT-132577 | Drug | Capsule |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) of ACT-132577 | Cmax of ACT-132577 will be derived by non-compartmental analysis of the plasma concentration-time profiles | 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 | 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 | From baseline to up to 16 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From baseline to up to 16 days |
| Terminal half-life [t(1/2)] |
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Inclusion Criteria:
ALL SUBJECTS:
HEALTHY SUBJECTS:
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).
Exclusion Criteria:
ALL SUBJECTS:
SEVERE RENAL FUNCTION IMPAIRMENT SUBJECTS:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Idorsia Pharmaceuticals Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CEPHA | Pilsen | 32300 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31435905 | Background | 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. |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C572762 | aprocitentan |
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t1/2 of ACT-132577 will be derived by non-compartmental analysis of the plasma concentration-time profiles
| 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 | 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 | 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 | From baseline to up to 16 days |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |