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COMPLETEDPHASE1

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

NCT03913000•Idorsia Pharmaceuticals Ltd.

View on ClinicalTrials.gov

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

Eligibility

Age

18 - 79 years

Sex

ALL

Healthy Volunteers

Yes

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).
+3 more criteria

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.
+4 more criteria

Locations (1)

CRS Clinical Research Services Kiel GmbH

Kiel, Germany

Key Dates

Start Date

April 29, 2019

Primary Completion Date

August 22, 2019

Completion Date

August 22, 2019

Last Updated

November 22, 2019

Enrollment

ACTUAL participants

Conditions

Renal Impairment

Interventions

ID-085

DRUG

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Renal Impairment

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ACTIVE_NOT_RECRUITINGPHASE1

A Study of Pharmacokinetics and Safety of LY3537031 in Participants With Normal Renal Function and Participants With Renal Impairment

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Renal ImpairmentHealthy+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 22, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Investigation of the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Opemalirsen (AZD2373)

A Study of Pharmacokinetics and Safety of LY3537031 in Participants With Normal Renal Function and Participants With Renal Impairment

A Study to Test How BI 456906 is Taken up in the Blood of People With and Without Kidney Problems

A Study of RG002C0106 Injection in Adult Participants With Normal Renal Function and Mild-to-Moderate Renal Impairment

A Study to Investigate the Pharmacokinetics, Safety and Tolerability of AZD5462 in Participants With Renal Impairment

DESIR. Evaluation of the Pre-therapeutic Activity of Dihydropyrimidine dEShydrogenase (DPD) in Patients With Cancer and/or Renal Failure