A Drug Interaction Study of Clarithromycin and LY3502970 in Healthy Participants
A Phase 1, Open-label, Drug Interaction Study to Investigate the Effect of Multiple Doses of Clarithromycin on the Pharmacokinetics of LY3502970 in Healthy Participants
2 other identifiers
interventional
26
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Aug 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2022
CompletedFirst Posted
Study publicly available on registry
July 21, 2022
CompletedStudy Start
First participant enrolled
August 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 3, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 3, 2022
CompletedNovember 25, 2022
November 15, 2022
3 months
July 20, 2022
November 23, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3502970
PK: AUC of LY3502970
Predose up to 120 hours postdose
PK: Maximum Observed Concentration (Cmax) of LY3502970
PK: Cmax of LY3502970
Predose up to 120 hours postdose
Study Arms (2)
LY3502970 alone (Period 1)
EXPERIMENTALLY3502970 administered orally.
Clarithromycin + LY3502970 (Period 2)
EXPERIMENTALClarithromycin administered orally in combination with LY3502970 given orally.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lilly Centre for Clinical Pharmacology
Singapore, 138623, Singapore
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2022
First Posted
July 21, 2022
Study Start
August 1, 2022
Primary Completion
November 3, 2022
Study Completion
November 3, 2022
Last Updated
November 25, 2022
Record last verified: 2022-11-15
Data Sharing
- IPD Sharing
- Will not share