A Drug Interaction Study of Clarithromycin and LY3502970 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: LY3502970; Drug: Clarithromycin

Study type: Interventional

Funder types: Industry

Identifiers

NCT05469126

J2A-MC-GZGM (Other Identifier)

18507

Details and patient eligibility

About

The main purpose of this study is to determine the levels of study drug called LY3502970 in the blood stream when administered alone and in combination with clarithromycin in healthy participants. This study will last up to approximately 85 days for each participant.

Enrollment: 26 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants who are overtly healthy as determined by medical evaluation
• Participants with a body weight of 45 kilograms (kg) or more and body mass index (BMI) within the range of 18.5 to 35.0 kilograms per meter squared (kg/m²)
• Participants who have a hemoglobin level of at least 11.4 grams/deciliter (g/dL) for female participants and at least 12.5 g/dL for male participants
• Male participants who agree to use highly effective/effective methods of contraception and female participants not of childbearing potential

Exclusion criteria

• Participants who have a significant history of or current cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
• Participants who regularly use known drugs of abuse
• Women who are lactating and who are of child-bearing potential
• Participants who have known allergies to LY3502970, related compounds, or any components of the formulation

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

LY3502970 alone (Period 1)

Experimental group

Description:

LY3502970 administered orally.

Treatment:

Drug: LY3502970

Clarithromycin + LY3502970 (Period 2)

Experimental group

Description:

Clarithromycin administered orally in combination with LY3502970 given orally.

Treatment:

Drug: Clarithromycin

Drug: LY3502970