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

Renal Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03913000
• Other study ID #: ID-085-103
• Status: Completed
• Phase: Phase 1
• Start date: April 29, 2019
• Est. completion date: August 22, 2019

Study information

• Verified date: November 2019
• Source: Idorsia Pharmaceuticals Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 22, 2019
• Est. primary completion date: August 22, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Renal Impairment
• Renal Insufficiency

Intervention

Drug:
• ID-085
Hard capsules for oral administration formulated at a strength of 200 mg

Locations

Country	Name	City	State
Germany	CRS Clinical Research Services Kiel GmbH	Kiel

Sponsors (1)

Lead Sponsor	Collaborator
Idorsia Pharmaceuticals Ltd.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	The plasma AUC from zero to infinity (AUC0-inf), calculated with the apparent ?z	Will be derived by non-compartmental analysis of the plasma concentration-time profiles	Up to Day 3 after treatment administration
Primary	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
Primary	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
Primary	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
Primary	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