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

NCT ID: NCT05860933

Last Updated: 2024-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-08

Study Completion Date

2023-08-28

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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LY3537982 + Itraconazole (Part 1)

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

Group Type EXPERIMENTAL

LY3537982

Intervention Type DRUG

Administered orally.

Itraconazole

Intervention Type DRUG

Administered orally.

LY3537982 + Carbamazepine (Part 2)

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

Group Type EXPERIMENTAL

LY3537982

Intervention Type DRUG

Administered orally.

Carbamazepine

Intervention Type DRUG

Administered orally.

Interventions

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LY3537982

Administered orally.

Intervention Type DRUG

Itraconazole

Administered orally.

Intervention Type DRUG

Carbamazepine

Administered orally.

Intervention Type DRUG

Other Intervention Names

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Olomorasib

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Loxo Oncology, Inc.

INDUSTRY

Sponsor Role collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yingying Guo-Avrutin, MD, PhD

Role: STUDY_DIRECTOR

Loxo Oncology, Inc.

Locations

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ICON Early Development Services

San Antonio, Texas, United States

Site Status

ICON Early Development Services

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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J3M-OX-JZQD

Identifier Type: OTHER

Identifier Source: secondary_id

LOXO-RAS-22002

Identifier Type: -

Identifier Source: org_study_id

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