Multiple-Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study With LY3556050 in Healthy Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Study Overview
Brief Summary
The main purpose of this study is to learn more about the safety of LY3556050 after it is given by mouth to healthy participants. Blood tests will be performed to check how much LY3556050 gets into the bloodstream and how long the body takes to get rid of it. Each enrolled participant will receive multiple doses of LY3556050 or placebo and will remain in the study for up to 31 days.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Masking Description
Part A - Double-blind. Part B - Open label.
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy males or females of nonchild bearing potential, as determined by medical history
- •Have safety laboratory results within normal references ranges
- •Weight at least 50 kilograms (kg)
Exclusion Criteria
- •Have known allergies to LY3556050, iodine, metformin and related compounds
- •Abnormal electrocardiogram (ECG) or blood pressure at screening
- •Significant history of current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or endocrine disorders
- •Show evidence of active renal disease with estimated glomerular filtration rate (GFR) <90 milliliters per minute per 1.73 meters squared
Arms & Interventions
Metformin (Part B)
Metformin given orally. (Part B is optional.)
Intervention: Metformin (Drug)
LY3556050 (Part A)
LY3556050 administered orally.
Intervention: LY3556050 (Drug)
Placebo (Part A)
Placebo administered orally.
Intervention: Placebo (Drug)
Iohexol (Part B)
Iohexol given intravenously (IV). (Part B is optional.)
Intervention: Iohexol (Drug)
LY3556050+ Iohexol (Part B)
Iohexol given intravenously (IV) coadministered with oral doses of LY3556050. (Part B is optional.)
Intervention: LY3556050 (Drug)
LY3556050+ Iohexol (Part B)
Iohexol given intravenously (IV) coadministered with oral doses of LY3556050. (Part B is optional.)
Intervention: Iohexol (Drug)
LY3556050 + Metformin (Part B)
Metformin given orally coadministered with oral doses of LY3556050. (Part B is optional.)
Intervention: LY3556050 (Drug)
LY3556050 + Metformin (Part B)
Metformin given orally coadministered with oral doses of LY3556050. (Part B is optional.)
Intervention: Metformin (Drug)
Outcomes
Primary Outcomes
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time Frame: Baseline through Final Follow-up (up to Week 9)]
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Secondary Outcomes
- Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3556050(Baseline through Day 17)
- PK: Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUCτ)(Baseline through Day 17)