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

Study Overview
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Brief Summary
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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

Official Title
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Open-label, Phase 1 Study to Investigate the Effects of Mild, Moderate, and Severe Renal Function Impairment on the Pharmacokinetics, Safety, and Tolerability of a Single Dose of ID-085

Conditions
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Renal Impairment

Intervention / Treatment
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* Drug: ID-085


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Sequential Assignment
Interventional 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ID-085 single dose<br>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). | Drug: ID-085<br>* Hard capsules for oral administration formulated at a strength of 200 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |