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An open-label, single-dose study to investigate the pharmacokinetics of ACT-1014-6470 in subjects with severe renal impairment compared to control subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (subjects with severe renal impairment) | Experimental |
| |
| Group B (control subjects) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACT-1014-6470 40 mg | Drug | ACT-1014-6470 will be available as soft gelatin capsules for oral administration formulated at a dose strength of 20 mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| PK of ACT-1014-6470 - Cmax | For both Group A (subjects with severe renal impairment) and Group B (control subjects) | Blood samples for PK analysis will be drawn at various time points (total duration: up to 6 days in Group A, up to 4 days in Group B). |
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| Measure | Description | Time Frame |
|---|---|---|
| PK of ACT-1014-6470 - Tmax | For both Group A (subjects with severe renal impairment) and Group B (control subjects) | Blood samples for PK analysis will be drawn at various time points (total duration: up to 6 days in Group A, up to 4 days in Group B). |
| Group B (control subjects): PK of ACT-1014-6470 - AUC0-inf |
Inclusion Criteria:
Additional inclusion criteria for subjects with severe renal impairment (Group A).
- Severe renal function impairment as confirmed at Screening based on an estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula of < 30 mL/min (not on dialysis).
Additional inclusion criteria for control subjects (Group B):
Exclusion Criteria:
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| APEX GmbH | Munich | 81241 | Germany |
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| ID | Term |
|---|---|
| C000726455 | ACT-1014-6470 |
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This is a prospective, open-label, single-dose, parallel-group, Phase 1 study.
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For both Group A (subjects with severe renal impairment) and Group B (control subjects) |
| Blood samples for PK analysis will be drawn at various time points (total duration: up to 6 days in Group A, up to 4 days in Group B). |
| Group B (control subjects): PK of ACT-1014-6470 - T1/2 | For both Group A (subjects with severe renal impairment) and Group B (control subjects) | Blood samples for PK analysis will be drawn at various time points (total duration: up to 6 days in Group A, up to 4 days in Group B). |