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

Phase 1

Completed

• Conditions: Renal Impairment
• Interventions: Drug: ID-085

• Registration Number: NCT03913000
• Lead Sponsor: Idorsia Pharmaceuticals Ltd.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-10
• Study First Submitted QC: 2019-04-10
• Study First Posted: 2019-04-12
• Study Start: 2019-04-29
• Primary Completion: 2019-08-22
• Study Completion: 2019-08-22
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-20
• Last Update Posted: 2019-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
ID-085 single dose	ID-085	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).

Primary Outcome Measures

Name	Time	Method
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
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 maximum plasma concentration (Cmax)	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
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
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

Trial Locations

Locations (1)

CRS Clinical Research Services Kiel GmbH; 🇩🇪 Kiel, Germany