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

• ClinicalTrials.gov Identifier: NCT03913000
• Recruitment Status: Completed
• First Posted: April 12, 2019
• Last Update Posted: November 22, 2019
• Sponsor: Idorsia Pharmaceuticals Ltd.
• Information provided by (Responsible Party): Idorsia Pharmaceuticals Ltd.

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

Condition or disease	Intervention/treatment	Phase
Renal Impairment	Drug: ID-085	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 32 participants
• Intervention Model: Sequential Assignment
• Intervention 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)
• Primary Purpose: Other
• 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
• Actual Study Start Date: April 29, 2019
• Actual Primary Completion Date: August 22, 2019
• Actual Study Completion Date: August 22, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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) [ Time Frame: Up to Day 3 after treatment administration ]
   Will be derived by non-compartmental analysis of the plasma concentration-time profiles
2. The plasma AUC from zero to infinity (AUC0-inf), calculated with the apparent λz [ Time Frame: Up to Day 3 after treatment administration ]
   Will be derived by non-compartmental analysis of the plasma concentration-time profiles
3. The maximum plasma concentration (Cmax) [ Time Frame: Up to Day 3 after treatment administration ]
   Will be derived by non-compartmental analysis of the plasma concentration-time profiles
4. The time to reach Cmax (tmax) [ Time Frame: Up to Day 3 after treatment administration ]
   Will be derived by non-compartmental analysis of the plasma concentration-time profiles
5. Apparent total body clearance (CL/F) [ Time Frame: Up to Day 3 after treatment administration ]
   Will be derived by non-compartmental analysis of the plasma concentration-time profiles
6. Apparent volume of distribution (Vz/F) [ Time Frame: Up to Day 3 after treatment administration ]
   Will be derived by non-compartmental analysis of the plasma concentration-time profiles

Eligibility Criteria

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

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.

Contacts and Locations

Locations

Germany

CRS Clinical Research Services Kiel GmbH

Kiel, Germany, 24105

Sponsors and Collaborators

Idorsia Pharmaceuticals Ltd.

Investigators

• Study Director: Clinical Trials; Idorsia Pharmaceuticals Ltd.

More Information

• Responsible Party: Idorsia Pharmaceuticals Ltd.
• ClinicalTrials.gov Identifier: NCT03913000
• Other Study ID Numbers: ID-085-103
• First Posted: April 12, 2019
• Last Update Posted: November 22, 2019
• Last Verified: November 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Renal Insufficiency; Kidney Diseases; Urologic Diseases