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OpenTrials
Completed

NCT Number: NCT05469126

A Drug Interaction Study of Clarithromycin and LY3502970 in Healthy Participants

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.

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Key information

Conditions

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Lilly Centre for Clinical Pharmacology

Singapore, 138623

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3502970

Drug

Administered orally.

Clarithromycin

Drug

Administered orally.

Primary outcomes

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

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

  2. 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

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

  3. PK: Maximum Observed Concentration (Cmax) of LY3502970

    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: Cmax of LY3502970 is reported.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 21, 2022
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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