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

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Carbamazepine; Drug: Itraconazole; Drug: LY3537982

Study type: Interventional

Funder types: Industry

Identifiers

NCT05860933

J3M-OX-JZQD (Other Identifier)

LOXO-RAS-22002

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

LY3537982 + Itraconazole (Part 1)

Experimental group

Description:

LY3537982 administered orally alone followed by LY3537982 administered in combination with itraconazole orally.

Treatment:

Drug: LY3537982

Drug: Itraconazole

LY3537982 + Carbamazepine (Part 2)

Experimental group

Description:

LY3537982 administered orally alone followed by LY3537982 administered in combination with carbamazepine orally.

Treatment:

Drug: LY3537982

Drug: Carbamazepine