Clinical trial NCT03913000: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Impairment
Lead sponsor: Idorsia Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2019-04-12
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: SEQUENTIAL
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
Primary purpose: OTHER

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


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.

Primary outcomes:
measure: 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)
timeFrame: Up to Day 3 after treatment administration
measure: The plasma AUC from zero to infinity (AUC0-inf), calculated with the apparent λz
timeFrame: Up to Day 3 after treatment administration
measure: The maximum plasma concentration (Cmax)
timeFrame: Up to Day 3 after treatment administration
measure: The time to reach Cmax (tmax)
timeFrame: Up to Day 3 after treatment administration
measure: Apparent total body clearance (CL/F)
timeFrame: Up to Day 3 after treatment administration
measure: Apparent volume of distribution (Vz/F)
timeFrame: Up to Day 3 after treatment administration
Secondary outcomes:
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: CRS Clinical Research Services Kiel GmbH
Study officials:
affiliation: Idorsia Pharmaceuticals Ltd.
name: Clinical Trials
role: STUDY_DIRECTOR
References: