Renal Impairment
Conditions
Brief summary
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
Interventions
DRUGID-085
Hard capsules for oral administration formulated at a strength of 200 mg
Sponsors
Idorsia Pharmaceuticals Ltd.
Study design
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
Yes
Inclusion criteria
All subjects: * Signed informed consent in a language understandable to the subject prior to any study-mandated procedure. * Male and female subjects aged between 18 and 79 years (inclusive) at screening. * Body mass index (BMI) of 18.0 to 34.0 kg/m2 (inclusive) at screening. Body weight of at least 50 kg. * Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day-1. They must consistently and correctly use (from at least first dosing, during the entire study, and for at least 30 days after last study treatment intake) a highly effective method of contraception with a failure rate of \< 1% per year and must use condoms, diaphragm or cervical cap with spermicide, or be sexually abstinent. Hormonal contraceptive must be initiated at least 1 month before study treatment administration. 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: * Mild renal function impairment: CLcr 60-89 mL/min (Group A). * Moderate renal function impairment: CLcr 30-59 mL/min (Group B). * Severe renal function impairment: CLcr \<30 mL/min (Group C). 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: * Pregnant or lactating women. * Known hypersensitivity to ID-085 or treatments of the same class, or any of its 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. Renal function impairment subjects: * Subjects on dialysis. * Hemoglobin concentration \< 9 g/dL. * Serum potassium concentration \> 6 mmol/L. * Platelet count \< 100 × 10\^6/mL. * History of severe renal stenosis. * History of clinically relevant bleeding disorder. * Gastrointestinal bleeding within 2 weeks prior to screening. * Presence of unstable diabetes mellitus.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Up to Day 3 after treatment administration | Will be derived by non-compartmental analysis of the plasma concentration-time profiles |
| The plasma AUC from zero to infinity (AUC0-inf), calculated with the apparent λz | Up to Day 3 after treatment administration | Will be derived by non-compartmental analysis of the plasma concentration-time profiles |
| The maximum plasma concentration (Cmax) | Up to Day 3 after treatment administration | Will be derived by non-compartmental analysis of the plasma concentration-time profiles |
| The time to reach Cmax (tmax) | Up to Day 3 after treatment administration | Will be derived by non-compartmental analysis of the plasma concentration-time profiles |
| Apparent total body clearance (CL/F) | Up to Day 3 after treatment administration | Will be derived by non-compartmental analysis of the plasma concentration-time profiles |
| Apparent volume of distribution (Vz/F) | Up to Day 3 after treatment administration | Will be derived by non-compartmental analysis of the plasma concentration-time profiles |
Countries
Germany
Outcome results
None listed