A Phase 1 Multiple-Dose Study to Investigate the Pharmacokinetics, Safety, and Tolerability of 2 Different Formulations of LY3502970 in Healthy Participants
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 39
- Locations
- 2
- Primary Endpoint
- Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970
Time Frame: Pre-dose on Day 1 up to 39 days post-dose
PK: Cmax of LY3502970
PK: Area Under the Plasma Concentration-Time Curve from 0 to 24 hours (AUC0-24) of LY3502970
Time Frame: Pre-dose on Day 1 up to 39 days post-dose
PK: AUC0-24 of LY3502970
PK: Time to Maximum Observed Concentration (Tmax) of LY3502970
Time Frame: Pre-dose on Day 1 up to 39 days post-dose
PK: Tmax of LY3502970
Secondary Outcomes
No secondary outcomes reported