A Study to Evaluate ID-085 in People With Mild, Moderate, and Severe Kidney Disease

• Status: Completed
• Trial end date: 2019-08-22
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Idorsia Pharmaceuticals Ltd.

Criteria

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.