A Drug Interaction Study of Clarithromycin and LY3502970 in Healthy Participants

Eli Lilly and Company26 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

LY3502970DRUG

Administered orally.

ClarithromycinDRUG

Administered orally.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Lilly Centre for Clinical Pharmacology

Singapore, Singapore

Outcomes

Primary Outcomes

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Time Zero to Infinity AUC(0-∞) of LY3502970

PK: AUC(0-∞) of LY3502970 is reported.

Time frame: Period 1: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours Day 1 postdose; Period 2: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 240 hours Day 21 postdose

PK: Area Under the Concentration Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [ AUC(0-tlast)] of LY3502970

PK: AUC(0-tlast) of LY3502970 is reported.

PK: Maximum Observed Concentration (Cmax) of LY3502970

PK: Cmax of LY3502970 is reported.

Data from ClinicalTrials.gov

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