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

Primary Purpose

Renal Impairment

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

ID-085

About this trial

This is an interventional other trial for Renal Impairment

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

CRS Clinical Research Services Kiel GmbH

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ID-085 single dose

Arm Description

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).

Outcomes

Primary Outcome Measures

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

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

The maximum plasma concentration (Cmax)

Will be derived by non-compartmental analysis of the plasma concentration-time profiles

The time to reach Cmax (tmax)

Will be derived by non-compartmental analysis of the plasma concentration-time profiles

Apparent total body clearance (CL/F)

Will be derived by non-compartmental analysis of the plasma concentration-time profiles

Apparent volume of distribution (Vz/F)

Will be derived by non-compartmental analysis of the plasma concentration-time profiles

Secondary Outcome Measures

Full Information

NCT ID

NCT03913000

First Posted

April 10, 2019

Last Updated

November 20, 2019

Sponsor

Idorsia Pharmaceuticals Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03913000

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

April 29, 2019 (Actual)

Primary Completion Date

August 22, 2019 (Actual)

Study Completion Date

August 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Idorsia Pharmaceuticals Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Impairment

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

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)

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ID-085 single dose

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

ID-085

Intervention Description

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

Primary Outcome Measure Information:

Title

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)

Description

Will be derived by non-compartmental analysis of the plasma concentration-time profiles

Time Frame

Up to Day 3 after treatment administration

Title

The plasma AUC from zero to infinity (AUC0-inf), calculated with the apparent λz

Description

Will be derived by non-compartmental analysis of the plasma concentration-time profiles

Time Frame

Up to Day 3 after treatment administration

Title

The maximum plasma concentration (Cmax)

Description

Will be derived by non-compartmental analysis of the plasma concentration-time profiles

Time Frame

Up to Day 3 after treatment administration

Title

The time to reach Cmax (tmax)

Description

Will be derived by non-compartmental analysis of the plasma concentration-time profiles

Time Frame

Up to Day 3 after treatment administration

Title

Apparent total body clearance (CL/F)

Description

Will be derived by non-compartmental analysis of the plasma concentration-time profiles

Time Frame

Up to Day 3 after treatment administration

Title

Apparent volume of distribution (Vz/F)

Description

Will be derived by non-compartmental analysis of the plasma concentration-time profiles

Time Frame

Up to Day 3 after treatment administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Idorsia Pharmaceuticals Ltd.

Official's Role

Study Director

Facility Information:

Facility Name

CRS Clinical Research Services Kiel GmbH

City

Kiel

ZIP/Postal Code

24105

Country

Germany

12. IPD Sharing Statement

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

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