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

NCT ID: NCT05469100

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-19
• Study Completion Date: 2019-08-07

Brief 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.

Conditions

Healthy; Renal Insufficiency

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Selpercatinib (Control; Normal Renal Function)

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.

Group Type: EXPERIMENTAL

Selpercatinib

Intervention Type: DRUG

Administered orally

Selpercatinib (Mild Renal Impairment)

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.

Group Type: EXPERIMENTAL

Selpercatinib

Intervention Type: DRUG

Administered orally

Selpercatinib (Moderate Renal Impairment)

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.

Group Type: EXPERIMENTAL

Selpercatinib

Intervention Type: DRUG

Administered orally

Selpercatinib (Severe Renal Impairment)

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.

Group Type: EXPERIMENTAL

Selpercatinib

Intervention Type: DRUG

Administered orally

Interventions

Selpercatinib

Administered orally

Intervention Type: DRUG

Other Intervention Names

LY3527723; LOXO-292

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Loxo Oncology, Inc.

INDUSTRY

Sponsor Role: collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

Anaheim Regional Center

Anaheim, California, United States

Stanford Health Care, Valley Care Program

Pleasanton, California, United States

Orange County Research Center

Tustin, California, United States

Riverside Clinical Research

Edgewater, Florida, United States

Clinical Pharmacology of Miami

Miami, Florida, United States

Orlando Clinical Research Center

Orlando, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

J2G-OX-JZJE

Identifier Type: OTHER

Identifier Source: secondary_id

LOXO-RET-18023

Identifier Type: OTHER

Identifier Source: secondary_id

17484

Identifier Type: -

Identifier Source: org_study_id