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

Healthy Clinical Trial

Official title:

Open-label, Nonrandomized, Single-dose, Parallel-group, Safety, Tolerance, and Pharmacokinetic Study of LOXO-292 Administered to Fasted Hepatically Impaired Male and Female Subjects and Fasted Matched-control Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05436912
• Other study ID #: 17483
• Secondary ID: J2G-OX-JZJDLOXO-
• Status: Completed
• Phase: Phase 1
• Start date: December 10, 2018
• Est. completion date: October 30, 2019

Study information

• Verified date: April 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 30, 2019
• Est. primary completion date: October 4, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Hepatic Impairment

Intervention

Drug:
• Selpercatinib
Administered orally.

Locations

Country	Name	City	State
United States	Orange County Research Institute	Anaheim	California
United States	Riverside Clinical Research	Edgewater	Florida
United States	Clinical Pharmacology of Miami	Miami	Florida
United States	National Institute of Clinical Research	Monterey Park	California
United States	Orlando Clinical Research Center	Orlando	Florida
United States	The Texas Liver Institute	San Antonio	Texas
United States	Orange County Research Center	Tustin	California

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	Loxo Oncology, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Maximum observed concentration (Cmax) of Selpercatinib	Cmax of Selpercatinib	Pre-dose up to 240 hour post-dose (Days 1-11)
Primary	PK: Time to reach Cmax (Tmax) of Selpercatinib	Tmax of Selpercatinib	Pre-dose up to 240 hour post-dose (Days 1-11)
Primary	PK: Area under the concentration-time curve (AUC), from time 0 to the last observed non-zero concentration (AUC0-t) of Selpercatinib	AUC0-t of Selpercatinib	Pre-dose up to 240 hour post-dose (Days 1-11)
Primary	PK: AUC extrapolated to infinity (AUC0-8) of Selpercatinib	AUC0-8 of Selpercatinib	Pre-dose up to 240 hour post-dose (Days 1-11)
Primary	PK: Percentage extrapolation for AUC (%AUCextrap) of Selpercatinib	%AUCextrap of Selpercatinib	Pre-dose up to 240 hour post-dose (Days 1-11)
Primary	PK: Apparent terminal elimination rate constant (?z) of Selpercatinib	?z of Selpercatinib	Pre-dose up to 240 hour post-dose (Days 1-11)
Primary	PK: Apparent terminal elimination half-life (t1/2) of Selpercatinib	t1/2 of Selpercatinib	Pre-dose up to 240 hour post-dose (Days 1-11)
Primary	PK: Apparent systemic clearance (CL/F) of Selpercatinib	CL/F of Selpercatinib	Pre-dose up to 240 hour post-dose (Days 1-11)
Primary	PK: Apparent volume of distribution during the terminal phase (Vd/F) of Selpercatinib	Vd/F of Selpercatinib	Pre-dose up to 240 hour post-dose (Days 1-11)
Primary	PK: Mean residence time (MRT) of Selpercatinib	MRT of Selpercatinib	Pre-dose up to 240 hour post-dose (Days 1-11)
Primary	Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.	Baseline through Week 7