A Study of Selpercatinib (LY3527723) in Healthy Participants

Healthy Clinical Trial

Official title:

A Phase I, Single-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LOXO-292 in Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05338515
• Other study ID #: 17485
• Secondary ID: J2G-OX-JZJFLOXO-
• Status: Completed
• Phase: Phase 1
• Start date: February 12, 2019
• Est. completion date: March 26, 2019

Study information

• Verified date: April 2022
• 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 determine how safe and how well tolerated selpercatinib is when given as oral doses to healthy participants. The study will also assess how fast selpercatinib gets into the blood stream and how long it takes the body to remove it. The study will last up to about 6 weeks, inclusive of screening period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 26, 2019
• Est. primary completion date: March 12, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Female participants of non-childbearing potential who are agreeable to take birth control measures until study completion

• 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• Have previously participated or withdrawn from this study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 Period 2

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Selpercatinib
Administered orally.

Locations

Country	Name	City	State
United States	Celerion	Tempe	Arizona

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	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 Day 8
Secondary	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	Pre-dose up to 168 hour post-dose
Secondary	PK: Area under the concentration-time curve, from time 0 to Hour 24 (AUC0-24) of Selpercatinib	PK: AUC0-24 of Selpercatinib	Pre-dose up to 168 hour post-dose
Secondary	PK: Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf) of Selpercatinib	PK: AUC0-inf of Selpercatinib	Pre-dose up to 168 hour post-dose
Secondary	PK: Percent of AUC0-inf extrapolated (AUC%extrap) of Selpercatinib	PK: AUC%extrap of Selpercatinib	Pre-dose up to 168 hour post-dose
Secondary	PK: Apparent total plasma clearance after oral (extravascular) administration (CL/F) of Selpercatinib	PK: CL/F of Selpercatinib	Pre-dose up to 168 hour post-dose
Secondary	PK: Maximum observed concentration (Cmax) of Selpercatinib	PK: Cmax of Selpercatinib	Pre-dose up to 168 hour post-dose
Secondary	PK: Time to reach Cmax (Tmax) of Selpercatinib	PK: Tmax of Selpercatinib	Pre-dose up to 168 hour post-dose
Secondary	PK: Apparent first-order terminal elimination rate constant (Kel) of Selpercatinib	PK: Kel of Selpercatinib	Pre-dose up to 168 hour post-dose
Secondary	PK: Apparent volume of distribution during the terminal elimination phase (Vz/F) of Selpercatinib	PK: Vz/F of Selpercatinib	Pre-dose up to 168 hour post-dose