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

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy; Renal Insufficiency

Treatments: Drug: Selpercatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT05469100

17484

J2G-OX-JZJE (Other Identifier)

LOXO-RET-18023 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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37 participants in 4 patient groups

Selpercatinib (Control; Normal Renal Function)

Experimental group

Description:

Participants with normal renal function (estimated glomerular filtration rate greater than or equal to \[eGFR ≥ 90 milliliters per minute (mL/min) per 1.73 square meters (m²)\] received a single 160 milligrams (mg) oral dose of Selpercatinib on Day 1, administered in a fasted state.

Treatment:

Drug: Selpercatinib

Selpercatinib (Mild Renal Impairment)

Experimental group

Description:

Participants with mild renal impairment (eGFR between 60 and 90 mL/min/1.73 m²) received a single 160 mg oral dose of Selpercatinib on Day 1, administered in a fasted state.

Treatment:

Drug: Selpercatinib

Selpercatinib (Moderate Renal Impairment)

Experimental group

Description:

Participants with moderate renal impairment (eGFR between 30 and 60 mL/min/1.73 m²) received a single 160 mg oral dose of Selpercatinib on Day 1, administered in a fasted state.

Treatment:

Drug: Selpercatinib

Selpercatinib (Severe Renal Impairment)

Experimental group

Description:

Participants with severe renal impairment (eGFR less than (\<) 30 mL/min/1.73 m² and not requiring hemodialysis) received a single 160 mg oral dose of Selpercatinib on Day 1, administered in a fasted state.

Treatment:

Drug: Selpercatinib