Clinical trial NCT01299285: Disposition of 14C-LY3009104 Following Oral Administration in Healthy Human Subjects
Official title: Disposition of 14C-LY3009104 Following Oral Administration in Healthy Human Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Absorption
Distribution
Metabolism
Excretion
Mass balance
Metabolic profile
Radiolabeled study
14C
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2011-02-18
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Percentage of the Total Radioactive Dose Administered Excreted From Urine and Feces
timeFrame: Baseline up to 120 hours
Secondary outcomes:
measure: Plasma Pharmacokinetics: LY3009104 Area Under the Concentration-Time Curve From Time Zero to Infinity [AUC(0-∞)]
timeFrame: Baseline up to 48 hours
measure: Plasma Pharmacokinetics: Radioactivity Area Under the Concentration-Time Curve From Time Zero to Infinity [AUC(0-∞)]
timeFrame: Baseline up to 48 hours
measure: Plasma Pharmacokinetics: Maximum Observed LY3009104 Concentration (Cmax)
timeFrame: Baseline up to 48 hours
measure: Plasma Pharmacokinetics: Maximum Observed Radioactivity Concentration (Cmax)
timeFrame: Baseline up to 48 hours
measure: Plasma Pharmacokinetics: LY3009104 and Radioactivity Time to Maximum Observed Concentration (Tmax)
timeFrame: Baseline up to 48 hours
measure: Percentage of Dose of LY3009104 and LY3009104 Metabolites in Urine
timeFrame: Baseline up to 48 hours
measure: Percentage of Dose of LY3009104 and LY3009104 Metabolites in Feces
timeFrame: Baseline up to 72 hours
measure: Percentage of Total Radioactivity of LY3009104 and LY3009104 Metabolites in Plasma
timeFrame: Baseline up to 24 hours
Other outcomes:
Locations:
city: Madison
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Mon - Fri, 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Wisconsin
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559, Mon - Fri, 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: