A Multiple Dose Study of LY3502970 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Esomeprazole; Drug: LY3502970

Study type: Interventional

Funder types: Industry

Identifiers

NCT05051566

17783 (Other Identifier)

J2A-MC-GZGD (Other Identifier)

2020-005750-15 (EudraCT Number)

QSC202755 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

26 participants in 5 patient groups

LY3502970 Prototype (Part A)

Experimental group

Description:

Multiple doses of LY3502970 prototype administered orally.

Treatment:

Drug: LY3502970

LY3502970 Reference (Part A)

Experimental group

Description:

Multiple doses of LY3502970 reference administered orally.

Treatment:

Drug: LY3502970

LY3502970 Prototype (Part B)

Experimental group

Description:

Multiple doses of LY3502970 prototype administered orally.

Treatment:

Drug: LY3502970

LY3502970 Reference (Part B)

Experimental group

Description:

Multiple doses of LY3502970 reference administered orally.

Treatment:

Drug: LY3502970

Esomeprazole (Part B)

Active Comparator group

Description:

Multiple doses of Esomeprazole (Proton Pump Inhibitor) administered orally.

Treatment:

Drug: Esomeprazole