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

NCT ID: NCT03913000

Last Updated: 2019-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-29
• Study Completion Date: 2019-08-22

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

Conditions

Renal Impairment

Study Design

• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

ID-085

Intervention Type: DRUG

Hard capsules for oral administration formulated at a strength of 200 mg

Interventions

ID-085

Hard capsules for oral administration formulated at a strength of 200 mg

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Idorsia Pharmaceuticals Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Idorsia Pharmaceuticals Ltd.

Locations

CRS Clinical Research Services Kiel GmbH

Kiel, , Germany

Countries

Germany

Other Identifiers

ID-085-103

Identifier Type: -

Identifier Source: org_study_id