A Multiple Dose Study of LY3502970 in Healthy Participants

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05051566
• Collaborator: Quotient Sciences (Industry)
• Enrollment: 26
• Location: 1
• Arms: 5
• Actual Duration (Months): 6.6
• Patients Per Site Per Month: 4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: LY3502970; Drug: Esomeprazole	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Official Title: A Multiple Dose Study in Healthy Participants to Investigate the Safety, Tolerability, and Pharmacokinetics of LY3502970
• Actual Study Start Date: Sep 16, 2021
• Actual Primary Completion Date: Apr 4, 2022
• Actual Study Completion Date: Apr 4, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LY3502970 Prototype (Part A) Multiple doses of LY3502970 prototype administered orally.	Drug: LY3502970; Administered orally.
Experimental: LY3502970 Reference (Part A) Multiple doses of LY3502970 reference administered orally.	Drug: LY3502970; Administered orally.
Experimental: LY3502970 Prototype (Part B) Multiple doses of LY3502970 prototype administered orally.	Drug: LY3502970; Administered orally.
Experimental: LY3502970 Reference (Part B) Multiple doses of LY3502970 reference administered orally.	Drug: LY3502970; Administered orally.
Active Comparator: Esomeprazole (Part B) Multiple doses of Esomeprazole (Proton Pump Inhibitor) administered orally.	Drug: Esomeprazole; Administered orally.

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970 [Predose up to 24 hours postdose]

   PK: Cmax of LY3502970

2. PK: Area Under the Concentration Versus Time Curve (AUC) of LY3502970 [Predose up to 24 hours postdose]

   PK: AUC of LY3502970

3. PK: Time of Maximum Observed Concentration (Tmax) of LY3502970 [Predose up to 24 hours postdose]

   PK: Tmax of LY3502970

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Quotient Clinical Ltd	Nottingham		United Kingdom	NG11 6JS

Sponsors and Collaborators

• Eli Lilly and Company
• Quotient Sciences

Investigators

• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT05051566
• Other Study ID Numbers: 17783; J2A-MC-GZGD; QSC202755; 2020-005750-15
• First Posted: Sep 21, 2021
• Last Update Posted: Apr 26, 2022
• Last Verified: Apr 15, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Esomeprazole

Study Results

No Results Posted as of Apr 26, 2022