A Multiple Dose Study of LY3502970 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY3502970; Drug: Esomeprazole

• Registration Number: NCT05051566
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-16
• Study First Submitted: 2021-09-16
• Study First Submitted QC: 2021-09-16
• Study First Posted: 2021-09-21
• Primary Completion: 2022-04-04
• Study Completion: 2022-04-04
• Status Verified: 2022-04-15
• Last Update Submitted: 2022-04-25
• Last Update Posted: 2022-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LY3502970 Reference (Part A)	LY3502970	Multiple doses of LY3502970 reference administered orally.
LY3502970 Prototype (Part A)	LY3502970	Multiple doses of LY3502970 prototype administered orally.
LY3502970 Prototype (Part B)	LY3502970	Multiple doses of LY3502970 prototype administered orally.
LY3502970 Reference (Part B)	LY3502970	Multiple doses of LY3502970 reference administered orally.
Esomeprazole (Part B)	Esomeprazole	Multiple doses of Esomeprazole (Proton Pump Inhibitor) administered orally.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970	Predose up to 24 hours postdose	PK: Cmax of LY3502970
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3502970	Predose up to 24 hours postdose	PK: AUC of LY3502970
PK: Time of Maximum Observed Concentration (Tmax) of LY3502970	Predose up to 24 hours postdose	PK: Tmax of LY3502970

Trial Locations

Locations (1)

Quotient Clinical Ltd; 🇬🇧 Nottingham, United Kingdom