Disposition of 14C-LY3009104 Following Oral Administration in Healthy Human Subjects

Lilly

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: LY3009104

Study type

Interventional

Funder types

Industry

Identifiers

NCT01299285

I4V-MC-JADG (Other Identifier)

14010

Details and patient eligibility

About

This is a single dose study of radiolabeled [14C]-LY3009104 in healthy male volunteers to study the absorption, distribution, metabolism, and elimination of LY3009104. This study requires minimum of 7 days and maximum of 22 days stay. This study is for research purposes only and is not intended to treat any medical condition.

Enrollment

6 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Overtly healthy males, as determined by medical history and physical examination
Will either be sterile or, if sexually active, agree to use a reliable method of birth control from check-in until 3 months after the end of the study
Body mass index (BMI) between 19 and 30 kilogram/square meter (kg/m²)
Experience on average 1 to 2 bowel movements per day
Clinical laboratory test results within the normal reference range for the clinical research unit (CRU) or, results with acceptable deviations which are judged to be not clinically significant by the investigator
Normal blood pressure and heart rate (sitting) as determined by the investigator
Venous access sufficient to allow blood sampling
Are reliable and willing to make themselves available for the duration of the study, and are willing to abide by the CRU policies and procedures, and study restrictions
Have given written informed consent approved by Lilly and the Institutional Review Board (IRB) governing the CRU

Exclusion criteria

Are currently enrolled in, have completed or discontinued, a clinical trial involving an investigational product or are concurrently enrolled in any other type of medical research judged not to be scientifically, or medically compatible with this study
Have known allergies to LY3009104, related compounds, or any components of the formulation
Have previously received the investigational product in this study, have completed or withdrawn from this study or any other study investigating LY3009104
History or presence of an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, is clinically significant
Current or recent history (<30 days prior to Screening and/or <45 days prior to Check-in) of a clinically significant bacterial, fungal, parasitic, viral (not including rhinopharyngitis), or mycobacterial infection
An Absolute Neutrophil Count (ANC) less than 2000 cells/microliter. For abnormal values a single repeat will be allowed
Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
Show evidence of significant active neuropsychiatric disease and in particular evidence of significant medical or psychiatric illness within the past 12 months
Have known substance dependence or abuse within 6 months prior to the study (according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition [DSM-IV] diagnosis), or regularly use known drugs of abuse and/or show positive findings on urinary drug screening
Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
Show evidence of hepatitis C and/or positive hepatitis C antibody
Evidence hepatitis B (active or surface antigen positive [HBsAg+]) or hepatitis B core antibody positive, hepatitis B surface antibody negative (HBcAb+, HBsAb-)
Use of prescription medication; over-the-counter medication; or herbal preparations containing St. John's Wort, kava, garlic, ginger, gingko biloba, or guarana within 14 days prior to admission
Consumption of grapefruit or grapefruit-containing foods or juices within 7 days prior to dosing or at any time during the study
Have an average weekly alcohol intake that exceeds 15 units per week, or are unwilling to stop alcohol consumption for the duration of the study (1 unit = 12 oz or 360 milliliter (mL) of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits)
Consume 5 or more cups of coffee (or other beverages of comparable caffeine content) per day, on a habitual basis, or any subjects unwilling to adhere to study caffeine restrictions (no caffeine 48 hours prior to admission until the end of study
Use of tobacco or nicotine-replacement products within the 6 months prior to study entry or at any time during the study
Have donated blood of more than 500 mL within the last month
Have participated in a 14C-study within the last 6 months prior to Check-in for this study. The total exposure from this study and the previous study must be within the Code of Federal Regulations (CFR) recommended levels considered safe (per 21 CFR 361.1), for example less than 5,000 millirem (mrem)/year whole body annual exposure
Exposure to significant radiation within 12 months prior to dose (for example, serial X-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring)