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OpenTrials
Completed

NCT Number: NCT06085482

A Phase I Study of LY3502970 in Healthy Participants

The main purpose of this study is to evaluate how much of the study drug (LY3502970) and the radioactive substance 14C incorporated LY3502970 gets into the bloodstream, how its broken down, and how long it takes the body to get rid of it. The study will last up to approximately 9 weeks for each participant.

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Key information

Conditions

Healthy

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Inc

Madison, Wisconsin, 53704, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Are overtly healthy as determined by medical evaluation
  • Participants with body weight of 45 kilograms (kg) or more and body mass index within the range 18.5 to 35.0 kilograms per meter squared (kg/m²), inclusive
  • Males who agree to use highly effective or effective methods of contraception and women not of childbearing potential may participate in this study

Exclusion criteria

  • Participants who have known allergies to LY3502970, related compounds, or any components of the formulation
  • Women who are lactating and women of child bearing potential (WOCBP) are excluded from the study
  • Participants who regularly use known drugs of abuse or show positive findings on drug screen

Treatment and study plan

LY3502970

Drug

Administered orally

[14C]-LY3502970

Drug

Administered IV

Primary outcomes

  1. Pharmacokinetics (PK): Absolute Bioavailability of LY3502970

    Time frame: Pre-oral dose, 0.5, 1, 2, 4, 6, 6.5, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 hours post-oral dose; 0 (immediately after IV dosing), 2, 5, 10, 15 minutes and 0.5, 1, 2, 4, 6, 10, 18, 30, 42, 66, 90, 114, 138, 162, 186 hours post-IV dose.

    Absolute bioavailability of LY3502970, expressed in percentage, was estimated using the AUC(0-∞) values from each individual participant based on IV dosed [14C]-LY3502970 compared to oral dosed LY3502970, using formula: [AUC0-∞(oral) x Dose (IV) divided by AUC0-∞(IV) x Dose (oral)] x100. The sampling time points from pre-oral dose through 186 hours post-IV dose were used to assess this outcome.

Secondary outcomes

  1. PK: Area Under the Curve Concentration Versus Time Curve From Zero to Infinity (AUC [0-∞]) of Total Radioactivity in Plasma

    Time frame: 0 (immediately after IV dosing), 2, 5, 10, 15 minutes and 0.5, 1, 2, 4, 6, 10, 18, 30, 42, 66, 90, 114, 138 hours post-IV dose

    PK: AUC [0-∞] of Total Radioactivity in Plasma.

  2. PK: AUC [0-∞] of [14C]-LY3502970 in Plasma

    Time frame: 0 (immediately after IV dosing), 2, 5, 10, 15 minutes and 0.5, 1, 2, 4, 6, 10, 18, 30, 42, 66, 90, 114, 138, 162, 186 hours post-IV dose

    PK: AUC [0-∞] of [14C]-LY3502970 in Plasma.

  3. PK: AUC [0-∞] of LY3502970 in Plasma

    Time frame: Pre-oral dose, 0.5, 1, 2, 4, 6, 6.5, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 hours post-oral dose

    PK: AUC [0-∞] of LY3502970 in Plasma.

  4. PK: Maximum Concentration (Cmax) of Total Radioactivity in Plasma

    Time frame: 0 (immediately after IV dosing), 2, 5, 10, 15 minutes and 0.5, 1, 2, 4, 6, 10, 18, 30, 42, 66, 90, 114, 138 hours post-IV dose

    PK: Cmax of Total Radioactivity in Plasma.

  5. PK: Cmax of [14C]-LY3502970 in Plasma

    Time frame: 0 (immediately after IV dosing), 2, 5, 10, 15 minutes and 0.5, 1, 2, 4, 6, 10, 18, 30, 42, 66, 90, 114, 138, 162, 186 hours post-IV dose

    PK: Cmax of [14C]-LY3502970 in Plasma.

  6. PK: Cmax of LY3502970 in Plasma

    Time frame: Pre-oral dose, 0.5, 1, 2, 4, 6, 6.5, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 hours post-oral dose

    PK: Cmax of LY3502970 in Plasma.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Single-Group, Open-Label, Single-Period, Phase 1 Study to Determine the Absolute Bioavailability of LY3502970 in Healthy Participants

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 17, 2023
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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