A Drug Interaction Study of Clarithromycin and LY3502970 in Healthy Participants

NCT ID: NCT05469126

Last Updated: 2022-11-25

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

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2022-11-03

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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LY3502970 alone (Period 1)

LY3502970 administered orally.

Group Type EXPERIMENTAL

LY3502970

Intervention Type DRUG

Administered orally.

Clarithromycin + LY3502970 (Period 2)

Clarithromycin administered orally in combination with LY3502970 given orally.

Group Type EXPERIMENTAL

LY3502970

Intervention Type DRUG

Administered orally.

Clarithromycin

Intervention Type DRUG

Administered orally.

Interventions

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LY3502970

Administered orally.

Intervention Type DRUG

Clarithromycin

Administered orally.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Lilly Centre for Clinical Pharmacology

Singapore, , Singapore

Site Status

Countries

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Singapore

Other Identifiers

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J2A-MC-GZGM

Identifier Type: OTHER

Identifier Source: secondary_id

18507

Identifier Type: -

Identifier Source: org_study_id

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