Disposition of 14C-LY2452473 Following Oral Administration in Healthy Human Subjects

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Completed

CT.gov ID

NCT01275157

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

5.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a single dose study of radiolabeled [14C]-LY2452473 in healthy male volunteers to study the absorption, distribution, metabolism, and elimination of LY2452473.

This study is for research purposes only and is not intended to treat any medical condition.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: LY2452473	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

6 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Official Title:

Disposition of [14C]-LY2452473 Following Oral Administration in Healthy Human Subjects

Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Feb 1, 2011

Actual Study Completion Date :

Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LY2452473 15 mg, containing 100 micro curies of 14C labeled LY2452473 taken once only	Drug: LY2452473 Administered orally as a liquid suspension

Arm

Intervention/Treatment

Experimental: LY2452473

15 mg, containing 100 micro curies of 14C labeled LY2452473 taken once only

Drug: LY2452473

Administered orally as a liquid suspension

Outcome Measures

Primary Outcome Measures

Urinary and fecal excretion of radioactivity over time expressed as a percentage of the total radioactive dose administered [baseline up to 22 days]

Secondary Outcome Measures

Plasma pharmacokinetics of LY2452473 and radioactivity maximum observed concentration (Cmax) [baseline up to 22 days]
Plasma pharmacokinetics of LY2452473 and radioactivity time of maximum observed concentration (tmax) [baseline up to 22 days]
Plasma pharmacokinetics of LY2452473 and radioactivity area under the concentration-time curve from time zero to the last timepoint with a measurable concentration (AUC 0 to tlast) [baseline up to 22 days]
Relative abundance of LY2452473 and the metabolites of LY2452473 in urine and feces [baseline up to 22 days]
Relative abundance of LY2452473 and the metabolites of LY2452473 in plasma [baseline up to 22 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Experience on average 1 to 2 bowel movements per day
Overtly healthy males, as determined by medical history and physical examination
Subjects 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 follow-up assessment
Are between the body mass index (BMI) of 19 and 29 kg^m2, inclusive
Clinical laboratory test results within the normal reference range for the clinical research unit laboratory or results with acceptable deviations which are judged to be not clinically significant by the investigator
Have venous access sufficient to allow blood sampling
Normal blood pressure and pulse rate (sitting) as determined by the investigator
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, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device other than the study drug 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 LY2452473 or related compounds
Within 30 days of the initial dose of study drug, have received treatment with a drug that has not received regulatory approval for any indication
Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study medication or interfering with the interpretation of data
Have any other condition that in the opinion of the investigator would preclude participation in the study
Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
Show evidence of human immunodeficiency virus (HIV) and/or positive human 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
Intended use of over-the-counter or herbal medication within 7 days or prescription medication within 14 days prior to dosing
Have donated more than 500 mL of blood within the last month
Have an average weekly alcohol intake that exceeds 14 units per week, or are unwilling to stop alcohol consumption for the duration of the 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)
Use of 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 any time during the study
Heavy caffeine drinkers defined by a regular intake of more than 5 cups (40-50 mg of caffeine per cup) of coffee (or equivalent in xanthine-containing beverages) per day or caffeine drinking subjects who have not had consistent daily caffeine consumption for 1 month prior to study entry or subjects not willing to maintain consistent caffeine consumption during the study
Have participated in a [14C]-study within the last 12 months. The previous radiolabeled study drug must have been received more than 6 months prior to Check-in for this study and the cumulative annual radiation exposure must be consistent with Food and Drug Administration (FDA) recommendations, for example whole body exposure less than 5,000 mrem/year
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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Madison	Wisconsin	United States

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director: 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), Eli Lilly and Company