A Study of the Effects of Itraconazole or Carbamazepine on LY3537982 in Healthy Participants

Healthy Clinical Trial

Official title:

A Phase 1 Study to Evaluate the Effects of Multiple Doses of Itraconazole or Carbamazepine on the Single-Dose Pharmacokinetics of LY3537982 in Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05860933
• Other study ID #: LOXO-RAS-22002
• Secondary ID: J3M-OX-JZQD
• Status: Completed
• Phase: Phase 1
• Start date: May 8, 2023
• Est. completion date: August 28, 2023

Study information

• Verified date: January 2024
• 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 evaluate the effect of itraconazole and carbamazepine on LY3537982 when administered as multiple doses by conducting the blood tests to measure how much LY3537982 is in the bloodstream and how the body handles and eliminates LY3537982 in adult healthy participants. The study will also evaluate the safety and tolerability of LY3537982. The study is conducted in two parts. Participants will stay in the research center during the study, which will last about 11 and 15 days for part 1 and part 2, respectively, not including screening.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 28, 2023
• Est. primary completion date: August 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy status as defined by the absence of evidence of any clinically significant active or chronic disease

• Body mass index (BMI): 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive

Exclusion Criteria:

• Females who are lactating or of childbearing potential

• Clinically significant history of any drug sensitivity, drug allergy, or food allergy

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3537982
Administered orally.
• Itraconazole
Administered orally.
• Carbamazepine
Administered orally.

Locations

Country	Name	City	State
United States	ICON Early Development Services	Salt Lake City	Utah
United States	ICON Early Development Services	San Antonio	Texas

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 LY3537982 administered with or without itraconazole	PK: Cmax of LY3537982 administered with or without itraconazole	Predose on day 1 up to 72 hours postdose on day 9
Primary	PK: Area Under the Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC[0-inf]) of LY3537982 administered with or without itraconazole	PK: AUC[0-inf] of LY3537982 administered with or without itraconazole	Predose on day 1 up to 72 hours postdose on day 9
Primary	PK: AUC from Time 0 to time of the last measurable concentration (AUClast) of LY3537982 administered with or without itraconazole	PK: AUClast of LY3537982 administered with or without itraconazole	Predose on day 1 up to 72 hours postdose on day 9
Primary	PK: Cmax of LY3537982 administered with or without carbamazepine	PK: Cmax of LY3537982 administered with or without carbamazepine	Predose on day 1 up to 72 hours postdose on day 13
Primary	PK: AUC[0-inf] of LY3537982 administered with or without carbamazepine	PK: AUC[0-inf] of LY3537982 administered with or without carbamazepine	Predose on day 1 up to 72 hours postdose on day 13
Primary	PK: AUClast of LY3537982 administered with or without carbamazepine	PK: AUClast of LY3537982 administered with or without carbamazepine	Predose on day 1 up to 72 hours postdose on day 13