Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective of this study is to evaluate the pharmacokinetics (PK), tolerabilty and safety of a single dose of ID-085 in subjects with mild, moderate, and severe renal function impairment compared to healthy subjects
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ID-085 single dose | Experimental | Administration of the study treatment 200 mg to renally impaired subjects will be done by severity, starting with group A (mild), and followed by group B (moderate), C (severe) and D (healthy subjects). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ID-085 | Drug | Hard capsules for oral administration formulated at a strength of 200 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve (AUC) from time zero to time t of the last measured concentration above the limit of quantification (AUC0-t) | Will be derived by non-compartmental analysis of the plasma concentration-time profiles | Up to Day 3 after treatment administration |
| The plasma AUC from zero to infinity (AUC0-inf), calculated with the apparent λz | Will be derived by non-compartmental analysis of the plasma concentration-time profiles | Up to Day 3 after treatment administration |
| The maximum plasma concentration (Cmax) | Will be derived by non-compartmental analysis of the plasma concentration-time profiles | Up to Day 3 after treatment administration |
| The time to reach Cmax (tmax) | Will be derived by non-compartmental analysis of the plasma concentration-time profiles | Up to Day 3 after treatment administration |
| Apparent total body clearance (CL/F) | Will be derived by non-compartmental analysis of the plasma concentration-time profiles | Up to Day 3 after treatment administration |
| Apparent volume of distribution (Vz/F) | Will be derived by non-compartmental analysis of the plasma concentration-time profiles | Up to Day 3 after treatment administration |
Not provided
Not provided
Inclusion Criteria:
All subjects:
Renal function impairment subjects:
• At screening and on Day -1, the stage of renal function impairment will be defined by Creatinine Clearance (CLcr) by the Cockcroft-Gault (C-G) equation:
The stage of renal impairment will need to be confirmed at Day -1 and the CLcr values on Day -1 will need to remain within ± 25% of the screening value.
Healthy subjects:
• Normal renal function confirmed by a CLcr ≥ 90 mL/min. Normal renal function will need to be confirmed at Day -1 and the CLcr value on Day -1 will need to remain within ± 25% of the screening value.
Exclusion Criteria:
All subjects:
Renal function impairment subjects:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Idorsia Pharmaceuticals Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRS Clinical Research Services Kiel GmbH | Kiel | 24105 | Germany |
Not provided
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
Single-center, open-label, single-dose study is conducted in male and female subjects with renal function impairment and in healthy subjects. Groups A (mild), B (moderate), C (severe) and D (healthy subjects) will be studied in a staggered way, starting with the group with mild renal function impairment
Not provided
Not provided
Not provided
Not provided
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |