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

Lilly

Status and phase: Completed; Phase 1

Conditions: Hepatic Impairment; Healthy

Treatments: Drug: Selpercatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT05436912

LOXO-RET-18022 (Other Identifier)

17483 (Other Identifier)

J2G-OX-JZJD (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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• Have previously participated or withdrawn from this study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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 4 patient groups

160 milligram (mg) Selpercatinib: Normal Hepatic Function

Experimental group

Description:

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

Treatment:

Drug: Selpercatinib

160 mg Selpercatinib: Mild Hepatic Impairment

Experimental group

Description:

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.

Treatment:

Drug: Selpercatinib

160 mg Selpercatinib: Moderate Hepatic Impairment

Experimental group

Description:

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.

Treatment:

Drug: Selpercatinib

160 mg Selpercatinib: Severe Hepatic Impairment

Experimental group

Description:

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.

Treatment:

Drug: Selpercatinib