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

NCT05860933 | Completed Phase 1 FDA Drug

• 2 other identifiers: LOXO-RAS-22002J3M-OX-JZQD
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

LY3537982 + Itraconazole (Part 1)

EXPERIMENTAL

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

Drug: LY3537982; Drug: Itraconazole

LY3537982 + Carbamazepine (Part 2)

EXPERIMENTAL

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

Drug: LY3537982; Drug: Carbamazepine

Interventions

LY3537982 DRUG

Administered orally.

Also known as: Olomorasib

LY3537982 + Carbamazepine (Part 2); LY3537982 + Itraconazole (Part 1)

Itraconazole DRUG

Administered orally.

LY3537982 + Itraconazole (Part 1)

Carbamazepine DRUG

Administered orally.

LY3537982 + Carbamazepine (Part 2)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Females who are lactating or of childbearing potential
• Clinically significant history of any drug sensitivity, drug allergy, or food allergy

Sponsors & Collaborators

• Eli Lilly and Company: lead
• Loxo Oncology, Inc.: collaborator

Study Sites (2)

ICON Early Development Services

San Antonio, Texas, 78209, United States

Location

ICON Early Development Services

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Interventions

Itraconazole; Carbamazepine

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Yingying Guo-Avrutin, MD, PhD

  Loxo Oncology, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: May 16, 2023
• Study Start: May 8, 2023
• Primary Completion: August 28, 2023
• Study Completion: August 28, 2023
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)