A Study of Effect of Selpercatinib (LY3527723) in Participants With Normal and Impaired Renal Function

• Status: Completed
• Trial end date: 2019-08-07
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to assess the amount of study drug that reaches the bloodstream and the time it takes for the body to get rid of it when given to participants with renal (kidney) impairment compared to healthy participants. The study will last up to 9 days, excluding screening.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eli Lilly and Company
• Collaborator: Loxo Oncology, Inc.

Criteria

Inclusion Criteria:

For all participants:

• Body mass index (BMI) ≥ 18.0 and ≤ 40.0 kilograms per meter squared (kg/m²) and had a minimum weight of at least 50 kg at screening

• Have normal blood pressure, pulse rate, electrocardiogram (ECG), and blood and urine laboratory test results that are acceptable for the study

• Female of non childbearing potential: must have undergone sterilization procedures at least 6 months prior to the Screening

• Males who are capable of fathering a child must agree to use contraception from the time of the dose administration through 6 months after the last dose

For renal participants:

• Participant has stable renal disease status and function at least 1 month prior to LOXO-292 administration.

• Participant is not currently or has not previously being on hemodialysis

• Baseline estimated glomerular filtration rate (eGFR) based on the Modification of Diet in Renal Disease (MDRD) equation at screening as follows:

• Severe Renal Impairment (RI): < 30 milliliter per minute (mL/min)/1.73m²

• Moderate RI: ≥ 30 and < 60 mL/min/1.73m²

• Mild RI: ≥ 60 and < 90 mL/min/1.73m²

The MDRD equation is as follows (for females multiply result by 0.742, if African American multiply result by 1.212):

eGFR = 175 x [serum creatinine in milligrams per deciliter (mg/dL) measured with a standardized assay]^-1.154 x (Age)^-0.203

Exclusion Criteria:

For renal participants:

• Has rapidly fluctuating renal function, as determined by historical measurements; or has demonstrated or suspected renal artery stenosis. Rapidly fluctuating renal function is defined as creatinine clearance or eGFR that differs by more than 20% within at least 3 months of the screening creatinine clearance or eGFR. If historical measurements are not available, then the 2 screening measurements will be used to demonstrate stability.

• Participants who have had a renal transplant, a nephrectomy, or participants with a known history of nephrotic syndrome.

• Participants who have required new medication for renal disease within 30 days prior to Check-in