Skip to main content
OpenTrials
Completed

NCT Number: NCT05051566

A Multiple Dose Study of LY3502970 in Healthy Participants

The main purpose of this study is to assess how fast LY3502970 gets into the blood stream and how long it takes the body to remove it when administered in multiple oral doses as new formulation compared to that of reference LY3502970 formulation. Information about safety and tolerability will be collected. The study is open to healthy participants. The study is conducted in two parts and it will last up to about 6 months, inclusive of screening period.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Clinical Ltd

Nottingham, NG11 6JS, United Kingdom

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.
  • Body mass index (BMI) of 18.5 to 35 kilograms per meter squared (kg/m²).

Exclusion criteria

  • Have an abnormal blood pressure and/or pulse rate as determined by the investigator -minor deviations acceptable to investigator are allowed
  • Have known liver disease, obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or have elevations in aminotransferases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) greater than 2X ULN (Upper Limit of Normal)
  • Have an abnormality in the 12-lead ECG at screening that, in the opinion of the investigator, increases the risks associated with participating in the study
  • Are women of child-bearing potential
  • Are women who are lactating

Treatment and study plan

LY3502970

Drug

Administered orally.

Esomeprazole

Drug

Administered orally.

Primary outcomes

  1. Part A: PK: Maximum Observed Concentration (Cmax) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation

    Time frame: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)

    Part A: Cmax of LY3502970 following the multiple administrations (i.e., last/sixth dose) of prototype formulations and the reference formulation. This includes the following: 16 mg reference capsule on Day 24, 16 mg Prototype 1 tablet administered on Day 30 (last/sixth dose of Test Phase 1) and Day 36 (last/sixth dose of Test Phase 2), and 16 mg Prototype 2 tablet administered on Day 30 (last/sixth dose of Test Phase 1) and Day 36 (last/sixth dose of Test Phase 2).

  2. Part A: PK: Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours Post-Dose (AUC(0-24)) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation

    Time frame: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)

    Part A: AUC(0-24) of LY3502970 following the multiple administrations (i.e., last/sixth dose) of prototype formulations and the reference formulation. This includes the following: 16 mg reference capsule on Day 24, 16 mg Prototype 1 tablet administered on Day 30 (last/sixth dose of Test Phase 1) and Day 36 (last/sixth dose of Test Phase 2), and 16 mg Prototype 2 tablet administered on Day 30 (last/sixth dose of Test Phase 1) and Day 36 (last/sixth dose of Test Phase 2).

  3. Part A: PK: Time of Maximum Observed Concentration (Tmax) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation

    Time frame: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)

    Part A: Tmax of LY3502970 following the multiple administrations (i.e., last/sixth dose) of prototype formulations and the reference formulation. This includes the following: 16 mg reference capsule on Day 24, 16 mg Prototype 1 tablet administered on Day 30 (last/sixth dose of Test Phase 1) and Day 36 (last/sixth dose of Test Phase 2), and 16 mg Prototype 2 tablet administered on Day 30 (last/sixth dose of Test Phase 1) and Day 36 (last/sixth dose of Test Phase 2).

  4. Part B: PK: Maximum Observed Concentration (Cmax) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation

    Time frame: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)

    Part B: Cmax of LY3502970 following the multiple administrations (i.e., last/sixth dose) of prototype formulations and the reference formulation. This includes the following:16 mg prototype 2 tablet (Fasted) on Day 24, 16 mg prototype 2 tablet (Fed) administered on Day 30 and 16 mg Prototype 2 tablet + PPI (Fasted) administered on Day 36.

  5. Part B: PK: Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours Post-dose (AUC(0-24)) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation

    Time frame: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)

    Part B: AUC(0-24) of LY3502970 following the multiple administrations (i.e., last/sixth dose) of prototype formulations and the reference formulation. This includes the following:16 mg prototype 2 tablet (Fasted) on Day 24, 16 mg prototype 2 tablet (Fed) administered on Day 30 and 16 mg Prototype 2 tablet + PPI (Fasted) administered on Day 36.

  6. Part B: PK: Time of Maximum Observed Concentration (Tmax) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation

    Time frame: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)

    Part B: Tmax of LY3502970 following the multiple administrations (i.e., last/sixth dose) of prototype formulations and the reference formulation. This includes the following:16 mg prototype 2 tablet (Fasted) on Day 24, 16 mg prototype 2 tablet (Fed) administered on Day 30 and 16 mg Prototype 2 tablet + PPI (Fasted) administered on Day 36.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • Quotient Sciences

Registry information

Official study title

A Multiple Dose Study in Healthy Participants to Investigate the Safety, Tolerability, and Pharmacokinetics of LY3502970

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 21, 2021
Registry last updated
May 29, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.