A Study of Two Different Formulations of LY3502970 in Healthy Participants

NCT ID: NCT05341089

Last Updated: 2022-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-17
• Study Completion Date: 2022-09-01

Brief Summary

The main purpose of this study is to conduct blood tests to measure how much LY3502970 is in the bloodstream when administered as two different formulations in healthy participants. The study will also evaluate the safety and tolerability of LY3502970. The study will last up to 13 weeks excluding the screening period.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

LY3502970 (Formulation 1)

LY3502970 administered orally.

Group Type: EXPERIMENTAL

LY3502970

Intervention Type: DRUG

Administered orally.

LY3502970 (Formulation 2)

LY3502970 administered orally.

Group Type: EXPERIMENTAL

LY3502970

Intervention Type: DRUG

Administered orally.

Interventions

LY3502970

Administered orally.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Are overtly healthy as determined by medical evaluation
• Participants who have a hemoglobin level of at least 11.4 grams per deciliter (g/dL) for female participants and at least 12.5 g/dL for male participants
• Participants with a body weight of at least 45 kilograms (kg) and body mass index (BMI) of 18.5 to 35.0 kilograms per meter squared (kg/m²)
• Male participants who agree to use highly effective/effective methods of contraception and female participants not of childbearing potential

Exclusion Criteria

• Participants who have any abnormality in the 12-lead electrocardiogram (ECG) at screening
• Participants who have an abnormal blood pressure, pulse rate, or both, which are deemed to be clinically significant by the investigator, at screening
• Participants who have known allergies to LY3502970, related compounds, or any components of the formulation
• Participants who have used or intend to use over-the-counter or prescription medication including herbal medications or traditional medications within 14 days prior to dosing
• Participants who show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies, or both. A negative test within 6 months of screening would not need to be repeated.
• Participants who show evidence of hepatitis C and/or positive hepatitis C antibody, or both. A negative test within 6 months of screening would not need to be repeated.
• Participants who show evidence of hepatitis B, positive hepatitis B surface antigen, and/or positive hepatitis B core antibody, or all. A negative test within 6 months of screening would not need to be repeated.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

Lilly Centre for Clinical Pharmacology

Singapore, , Singapore

Countries

Singapore

Other Identifiers

J2A-MC-GZGH

Identifier Type: OTHER

Identifier Source: secondary_id

17785

Identifier Type: -

Identifier Source: org_study_id