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

Primary Purpose

Healthy, Renal Insufficiency

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Selpercatinib

About this trial

This is an interventional basic science trial for Healthy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Anaheim Regional Center
Stanford Health Care, Valley Care Program
Orange County Research Center
Riverside Clinical Research
Clinical Pharmacology of Miami
Orlando Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Cohort 1: Selpercatinib (Healthy participants)

Cohort 2: Selpercatinib (Participants with mild renal impairment)

Cohort 3: Selpercatinib (Participants with moderate renal impairment)

Cohort 4: Selpercatinib (Participants with severe renal impairment)

Arm Description

Single oral dose of Selpercatinib administered in a fasted state to participants with normal renal function.

Single oral dose of Selpercatinib administered in a fasted state to participants with mild renal impairment.

Single oral dose of Selpercatinib administered in a fasted state to participants with moderate renal impairment.

Single oral dose of Selpercatinib administered in a fasted state to participants with severe renal impairment and not on dialysis.

Outcomes

Primary Outcome Measures

Pharmacokinetics (PK): Area under the concentration-time curve, from time 0 to the last observed non-zero concentration (AUC0-t) of Selpercatinib

PK: AUC0-t of Selpercatinib

PK: Area under the concentration-time curve, from time 0 to Hour 24 (AUC0-24) of Selpercatinib

PK: AUC0-24 of Selpercatinib

PK: Area under the concentration-time curve, from time 0 extrapolated to infinity (AUC0-inf) of Selpercatinib

PK: AUC0-inf of Selpercatinib

PK: Percent of AUC0-inf extrapolated (AUC%extrap) of Selpercatinib

PK: AUC%extrap of Selpercatinib

PK: Apparent total plasma clearance after oral (extravascular) administration (CL/F) of Selpercatinib

PK: CL/F of Selpercatinib

PK: Maximum observed concentration (Cmax) of Selpercatinib

PK: Cmax of Selpercatinib

PK: Time to reach Cmax (Tmax) of Selpercatinib

PK: Tmax of Selpercatinib

PK: Apparent first order terminal elimination rate constant (Kel) of Selpercatinib

PK: Kel of Selpercatinib

PK: Apparent first-order terminal elimination half-life (t½) of Selpercatinib

PK: t½ of Selpercatinib

PK: Apparent volume of distribution during the terminal elimination phase after oral (extravascular) administration (Vz/F) of Selpercatinib

PK: Vz/F of Selpercatinib

PK: Total amount of drug excreted in the urine over the entire period of sample collection (Ae) of Selpercatinib

PK: Ae of Selpercatinib

PK: Fraction of drug excretion during each collection interval (Fe) of Selpercatinib

PK: Fe of Selpercatinib

PK: Renal clearance (CLr) of Selpercatinib

PK: CLr of Selpercatinib

Secondary Outcome Measures

Full Information

NCT ID

NCT05469100

First Posted

July 20, 2022

Last Updated

July 20, 2022

Sponsor

Eli Lilly and Company

Collaborators

Loxo Oncology, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05469100

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

December 19, 2018 (Actual)

Primary Completion Date

August 7, 2019 (Actual)

Study Completion Date

August 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

Collaborators

Loxo Oncology, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy, Renal Insufficiency

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

37 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1: Selpercatinib (Healthy participants)

Arm Type

Experimental

Arm Description

Single oral dose of Selpercatinib administered in a fasted state to participants with normal renal function.

Arm Title

Cohort 2: Selpercatinib (Participants with mild renal impairment)

Arm Type

Experimental

Arm Description

Single oral dose of Selpercatinib administered in a fasted state to participants with mild renal impairment.

Arm Title

Cohort 3: Selpercatinib (Participants with moderate renal impairment)

Arm Type

Experimental

Arm Description

Single oral dose of Selpercatinib administered in a fasted state to participants with moderate renal impairment.

Arm Title

Cohort 4: Selpercatinib (Participants with severe renal impairment)

Arm Type

Experimental

Arm Description

Single oral dose of Selpercatinib administered in a fasted state to participants with severe renal impairment and not on dialysis.

Intervention Type

Drug

Intervention Name(s)

Selpercatinib

Other Intervention Name(s)

LY3527723, LOXO-292

Intervention Description

Administered orally

Primary Outcome Measure Information:

Title

Pharmacokinetics (PK): Area under the concentration-time curve, from time 0 to the last observed non-zero concentration (AUC0-t) of Selpercatinib

Description

PK: AUC0-t of Selpercatinib

Time Frame