A Study of Effects of Selpercatinib in Hepatically Impaired Participants and Healthy Participants

NCT ID: NCT05436912

Last Updated: 2025-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-10
• Study Completion Date: 2019-10-30

Brief Summary

The main purpose of this study is to assess how selpercatinib gets into the blood stream and how long it takes the body to remove it when administered to participants with impaired hepatic function compared to healthy participants. Information about safety and tolerability will be collected. The study will last up to about 7 weeks, inclusive of screening period.

Conditions

Healthy; Hepatic Impairment

Study Design

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

Study Groups

160 milligram (mg) Selpercatinib: Normal Hepatic Function

160 mg selpercatinib administered orally to healthy participants after at least a 2-hour fast on Day 1.

Group Type: EXPERIMENTAL

Selpercatinib

Intervention Type: DRUG

Administered orally.

160 mg Selpercatinib: Mild Hepatic Impairment

160 mg selpercatinib administered orally to participants with mild hepatic impairment per Child-Pugh \[CP\] classification (CP Class A, score of 5 or 6) after at least a 2-hour fast on Day 1.

Group Type: EXPERIMENTAL

Selpercatinib

Intervention Type: DRUG

Administered orally.

160 mg Selpercatinib: Moderate Hepatic Impairment

160 mg selpercatinib administered orally to participants with moderate hepatic impairment per CP classification (CP Class B, score of 7 to 9) after at least a 2-hour fast on Day 1.

Group Type: EXPERIMENTAL

Selpercatinib

Intervention Type: DRUG

Administered orally.

160 mg Selpercatinib: Severe Hepatic Impairment

160 mg Selpercatinib administered orally to participants with severe hepatic impairment per CP classification (CP Class C, score of 10 to 15) after at least a 2-hour fast on Day 1.

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

• Female participants of non-childbearing potential who are agreeable to take birth control measures until study completion
• Males who are capable of fathering a child must agree to use one of the following methods of contraception from the time of the dose administration through 6 months after dose administration:

• Male sterilization, with documented confirmation of surgical success. Male subjects will be surgically sterile for at least 90 days prior to Check-in (Day -1). If documentation is not available, male subjects must follow one of the contraception methods below:
• Male condom with spermicide, or
• For a female partner of male study participant:
• Intrauterine device (IUD) (hormonal IUD; eg, Mirena®). Copper IUDs are acceptable (eg, ParaGard®);
• Established use of oral, implanted, transdermal, or hormonal method of contraception associated with inhibition of ovulation; or
• Bilateral tubal ligation.
• Body mass index (BMI) ≥ 18.0 and ≤ 32.0 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

Exclusion Criteria

• Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
• Have previously participated or withdrawn from this study
• Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
• Had blood loss of more than 500 milliliters (mL) within the previous 30 days of study screening
• Require treatment with inducers or inhibitors of cytochrome P450 (CYP) CYP3A within 14 days before the first dose of study drug through the end of treatment or early termination

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 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

Orange County Research Institute

Anaheim, California, United States

National Institute of Clinical Research

Monterey Park, 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

The Texas Liver Institute

San Antonio, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

J2G-OX-JZJD

Identifier Type: OTHER

Identifier Source: secondary_id

LOXO-RET-18022

Identifier Type: OTHER

Identifier Source: secondary_id

17483

Identifier Type: -

Identifier Source: org_study_id