A Study of LY3337641 in Healthy Male Participants

Lilly

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: [¹⁴C]-LY3337641

Study type

Interventional

Funder types

Industry

Identifiers

NCT02914379

16297

I8K-MC-JPDE (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to measure how much LY3337641 gets into the bloodstream and how long it takes the body to get rid of it. In addition, the safety and tolerability of the study drug will be evaluated.

Participants will be admitted to a clinical research unit (CRU) the day before dosing. Participants remain confined to the CRU for at least 7 days. Participants may be discharged from the CRU any time after 7 days post-dose (Day 8), and up to a maximum of 21 days post-dose (Day 22).

This study will last approximately 30 days for each participant, not including screening. Screening is required within 28 days prior to the start of the study.

Enrollment

6 patients

Sex

Male

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Overtly healthy males, as determined by medical history and physical examination
Have a body mass index (BMI) between 18.5 and 32.0 kilograms per meter squared (kg/m²)
Have clinical laboratory test results within normal reference range for the population or investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
Have venous access sufficient to allow for blood sampling as per the protocol
Are able and willing to give signed informed consent
Generally have a minimum of 1 bowel movement per day

Exclusion criteria

Have participated, within the last 30 days, in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer, if known) should have passed
Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI) (cholecystectomy not acceptable), endocrine, hematological, dermatologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data
Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
Have used or intend to use over-the-counter or prescription medication, including herbal medications, within 14 days prior to dosing
Have donated blood of more than 500 milliliter (mL) within the month prior to screening
Have an average weekly alcohol intake that exceeds 21 units per week, and are unwilling to stop alcohol consumption for 48 hours prior to admission, and while resident in the clinical research unit (CRU)
In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study
Have had exposure to significant diagnostic, therapeutic, or employment related radiation within 12 months prior to dosing (serial x-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring)
Have participated in a [¹⁴C] study within the last 6 months prior to admission for this study. The total 12-month exposure from this study and a maximum of one other previous [¹⁴C]-study within 6 to 12 months of this study must be within the Code of Federal Regulations (CFR) recommended levels considered safe (per 21 CFR 361.1): less than 5000 Milli-rem (mrem) /year whole body annual exposure