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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Itraconazole; Drug: Carbamazepine; Drug: LY3537982

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Patient Advocacy; Phone Number: 855-569-6305; Email: clinicaltrials@loxooncology.com

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78209
      • ICON Early Development Services
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • ICON Early Development Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Collaborators: Loxo Oncology, Inc.
• Investigators: Study Director: Yingying Guo-Avrutin, MD, PhD, Loxo Oncology, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2023
• Primary Completion (Actual): August 28, 2023
• Study Completion (Actual): August 28, 2023

Study Registration Dates

• First Submitted: May 8, 2023
• First Submitted That Met QC Criteria: May 8, 2023
• First Posted (Actual): May 16, 2023

Study Record Updates

• Last Update Posted (Estimated): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Hormones, Hormone Substitutes, and Hormone Antagonists; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Anticonvulsants; Sodium Channel Blockers; Antimanic Agents; Hormone Antagonists; Cytochrome P-450 Enzyme Inducers; Antifungal Agents; Steroid Synthesis Inhibitors; Cytochrome P-450 CYP3A Inducers; 14-alpha Demethylase Inhibitors; Itraconazole; Carbamazepine
• Other Study ID Numbers: LOXO-RAS-22002; J3M-OX-JZQD (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No