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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY3537982; Drug: Itraconazole; Drug: Carbamazepine

• Registration Number: NCT05860933
• Lead Sponsor: Eli Lilly and Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-08
• Study First Submitted: 2023-05-08
• Study First Submitted QC: 2023-05-08
• Study First Posted: 2023-05-16
• Primary Completion: 2023-08-28
• Study Completion: 2023-08-28
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-07
• Last Update Posted: 2024-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3537982 + Itraconazole (Part 1)	LY3537982	LY3537982 administered orally alone followed by LY3537982 administered in combination with itraconazole orally.
LY3537982 + Itraconazole (Part 1)	Itraconazole	LY3537982 administered orally alone followed by LY3537982 administered in combination with itraconazole orally.
LY3537982 + Carbamazepine (Part 2)	LY3537982	LY3537982 administered orally alone followed by LY3537982 administered in combination with carbamazepine orally.
LY3537982 + Carbamazepine (Part 2)	Carbamazepine	LY3537982 administered orally alone followed by LY3537982 administered in combination with carbamazepine orally.

Primary Outcome Measures

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

Trial Locations

Locations (1)

ICON Early Development Services; 🇺🇸 Salt Lake City, Utah, United States