A Study of LY3502970 in Healthy Male Participants

Lilly

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: [¹⁴C]-LY3502970

Drug: LY3502970

Study type

Interventional

Funder types

Industry

Identifiers

NCT04680767

17784

J2A-MC-GZGF (Other Identifier)

2020-003160-60 (EudraCT Number)

Details and patient eligibility

About

The main purpose of this study is to measure how much of the study drug gets into the bloodstream and how long it takes the body to eliminate it. This study will involve a single dose of ¹⁴C radiolabelled LY3502970. This means that a radioactive substance will be incorporated into the study drug. The purposes are to investigate the study drug and its breakdown products and to find out how much of these pass from blood into urine and feces. The study will last up to 8 weeks (maximum).

Enrollment

6 patients

Sex

Male

Ages

35 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Are overtly healthy males
Body weight within 50 and 100 kilograms (kg), inclusive, and body mass index within the range 18.0 and 32.0 kilograms per square meter (kg/m²) (inclusive)

Exclusion criteria

Females
Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product (IP); or of interfering with the interpretation of data
Have a history of Gilbert's syndrome or have total bilirubin level (TBL) above upper limit of normal (ULN) at screening
Have evidence of significant active neuropsychiatric disease, as determined by the investigator
Have had any exposure to LY3502970 or any other glucagon-like peptide-1 (GLP-1) analogs, or other related compounds within the prior 3 months, or any history of allergies to these medications
Are currently enrolled in a clinical study involving an investigational product (IP) or any other type of medical research judged not to be scientifically or medically compatible with this study
Have participated, within the last 3 months, in a clinical study involving an IP. If the previous IP has a long half-life, 5 half-lives or 3 months (whichever is longer) should have passed, prior to check-in
Have participated in any clinical trial involving a radiolabeled IP within 12 months prior to check-in
Show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies
Show evidence of hepatitis C and/or positive hepatitis C antibody
Show evidence of hepatitis B and/or positive hepatitis B surface antigen
Have had exposure to significant diagnostic, therapeutic, or employment-related radiation within 12 months prior to dosing (e.g., serial x-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring)