Disposition of 14C-LY2886721 Following Oral Administration in Healthy Human Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01367262
• Date of registration: 03/06/2011
• Primary sponsor: Eli Lilly and Company
• Public title: Disposition of 14C-LY2886721 Following Oral Administration in Healthy Human Subjects
• Scientific title: Disposition of [14C]-LY2886721 Following Oral Administration in Healthy Human Subjects
• Date of first enrolment: June 2011
• Target sample size: 8
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01367262
• Study type: Interventional
• Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Countries of recruitment

United States

Contacts

• Name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST)
• Affiliation: Eli Lilly and Company

Key inclusion & exclusion criteria

Inclusion Criteria:

- Healthy males as determined by medical history and physical examination

- Males will be sterile (including vasectomy) or if the subject is not sterile and is
sexually active, he will agree to use from Check-in until 3 months after
exit/discharge, 1 of the following approved methods of contraception: a male condom
with spermicide, a sterile sexual partner, use by female sexual partner of an
intrauterine device with spermicide, a female condom with spermicide, contraceptive
sponge with spermicide, a diaphragm with spermicide, a cervical cap with spermicide,
or oral, implantable, transdermal, intravaginal, or injectable contraceptives

- Have a body mass index of 19 to 30 kg/m2

- Have clinical laboratory test results within normal reference range for the
population or investigator 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

- Have normal blood pressure and heart rate (sitting)

- Experience a minimum of at least 1 bowel movement per day

- Are reliable and willing to make themselves available for the duration of the study
and are willing to follow study procedures

- Have given written informed consent approved by Lilly and the institutional review
board (IRB) governing the site

Exclusion Criteria:

- Are currently enrolled in, have completed, or discontinued within the last 30 days
from, a clinical trial involving an investigational product other than the
investigational product used in this study; 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 LY2886721, related compounds, or any components of the
formulation

- Are persons who have previously received the investigational product in this study,
have completed or withdrawn from this study or any other study investigating
LY2886721

- Have a Bazett's corrected QT (QTcB) interval value of >450 msec (males) or any
abnormality in the 12-lead Electrocardiograph(ECG) increases the risks associated
with participating in the study

- Have an abnormal blood pressure

- 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

- 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 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

- Intend to use prescription medication, over-the-counter medication, or herbal
preparations containing St. John's Wort, kava, garlic, ginger, ginko biloba, or
guarna within 14 days prior to admission

- Eating of grapefruit or grapefruit-containing foods, or drinking
grapefruit-containing juices within 7 days prior to dosing or any time during the
study

- Have used any tobacco- or nicotine-containing products (including, but not limited
to, cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges,
or nicotine gum) within 6 months prior to dosing

- Have donated blood of more than 500 mL within the last month

- Have an average weekly alcohol intake that exceeds 21 units per week (males up to age
65), or are unwilling to stop alcohol consumption from 48 hours prior to check-in
until end of study (1 unit = 12 oz or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz
or 45 mL of distilled spirits)

- Show evidence of significant active neuropsychiatric disease, in particular evidence
of significant medical or psychiatric illness within the past 12 months. Have any
other condition that would preclude participation in the study

- Have a history or presence of epilepsy, a history of seizures, any known brain
abnormalities, and a history of significant brain injury

- 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), less than 5,000 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)

- Have a history of clinically significant adverse drug reactions or "drug allergy" to
more than 3 types of systemically administered medications (all penicillins and
cephalosporins may be considered 1 type of medication for this purpose)

- Have a history of, or current, significant ophthalmological disease

- Have evidence of active renal disease (for example, diabetic renal disease,
polycystic kidney disease) or creatinine clearance of <80 mL/min (as calculated by
Cockcroft-Gault equation): Men: (140 - age) x (weight in kg)72 x (serum creatinine in
mg/dL)



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Healthy Subjects

Intervention(s)

Drug: LY2886721

Primary Outcome(s)

Percentage of Urinary and Fecal Excretion of LY2886721 Radioactivity Over Time [Time Frame: Baseline up to 9 days post dose]

Secondary Outcome(s)

Pharmacokinetics: Area under the concentration- time curve (AUC) of LY2886721 and radioactivity [Time Frame: Predose, up to 96 hours post dose]

Pharmacokinetics: Maximum concentration (Cmax) of LY2886721 and radioactivity [Time Frame: Predose, up to 96 hours post dose]

Proportion of LY2886721 and the metabolites of LY2886721 in urine, and feces [Time Frame: Baseline up to 9 days post dose]

Secondary ID(s)

13736

I4O-MC-BACD

Source(s) of Monetary Support

Please refer to primary and secondary sponsors