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

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

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

Study Overview

• Status: Completed
• Conditions: Renal Impairment
• Intervention / Treatment: Drug: ID-085

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Kiel, Germany, 24105
    • CRS Clinical Research Services Kiel GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ID-085 single dose; 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; Hard capsules for oral administration formulated at a strength of 200 mg

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Idorsia Pharmaceuticals Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2019
• Primary Completion (Actual): August 22, 2019
• Study Completion (Actual): August 22, 2019

Study Registration Dates

• First Submitted: April 10, 2019
• First Submitted That Met QC Criteria: April 10, 2019
• First Posted (Actual): April 12, 2019

Study Record Updates

• Last Update Posted (Actual): November 22, 2019
• Last Update Submitted That Met QC Criteria: November 20, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency
• Other Study ID Numbers: ID-085-103

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No