A Phase 1, Open-Label, Parallel-Cohort, Single-Dose Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of LOXO-292

Eli Lilly and Company6 sites in 1 country37 target enrollmentDecember 19, 2018

ConditionsHealthy Renal Insufficiency

InterventionsSelpercatinib

DrugsSelpercatinib

Overview

Phase: Phase 1
Intervention: Selpercatinib
Conditions: Healthy
Sponsor: Eli Lilly and Company
Enrollment: 37
Locations: 6
Primary Endpoint: Pharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to the Last Observed Non-zero Concentration (AUC0-t) of Selpercatinib in Plasma
Status: Completed
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 19, 2018

End Date

August 7, 2019

Last Updated

7 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Responsible Party

Sponsor

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

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

Arms & Interventions

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.

Intervention: Selpercatinib

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.

Intervention: Selpercatinib

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.

Intervention: Selpercatinib

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.

Intervention: Selpercatinib

Outcomes

Primary Outcomes

Pharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to the Last Observed Non-zero Concentration (AUC0-t) of Selpercatinib in Plasma