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

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05860933

Collaborator

Loxo Oncology, Inc. (Industry)

Enrollment

Location

Arms

3.3

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: LY3537982 Drug: Itraconazole Drug: Carbamazepine	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

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

Actual Study Start Date :

May 8, 2023

Anticipated Primary Completion Date :

Aug 10, 2023

Anticipated Study Completion Date :

Aug 17, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LY3537982 + Itraconazole (Part 1) LY3537982 administered orally alone followed by LY3537982 administered in combination with itraconazole orally.	Drug: LY3537982 Administered orally. Drug: Itraconazole Administered orally.
Experimental: LY3537982 + Carbamazepine (Part 2) LY3537982 administered orally alone followed by LY3537982 administered in combination with carbamazepine orally.	Drug: LY3537982 Administered orally. Drug: Carbamazepine Administered orally.

Arm

Intervention/Treatment

Experimental: LY3537982 + Itraconazole (Part 1)

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

Drug: LY3537982

Administered orally.

Drug: Itraconazole

Administered orally.

Experimental: LY3537982 + Carbamazepine (Part 2)

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

Drug: LY3537982

Administered orally.

Drug: Carbamazepine

Administered orally.

Outcome Measures

Primary Outcome Measures

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 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
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ICON Early Development Services	San Antonio	Texas	United States	78209

Sponsors and Collaborators

Eli Lilly and Company
Loxo Oncology, Inc.

Investigators

Study Director: Yingying Guo-Avrutin, MD, PhD, Loxo Oncology, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT05860933

Other Study ID Numbers:

LOXO-RAS-22002
J3M-OX-JZQD

First Posted:

May 16, 2023

Last Update Posted:

May 16, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Itraconazole

Carbamazepine

Study Results

No Results Posted as of May 16, 2023