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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01275157
• Other study ID #: 13276
• Secondary ID: I2N-MC-GPBF
• Status: Completed
• Phase: Phase 1
• First received: January 10, 2011
• Last updated: April 14, 2011
• Start date: January 2011
• Est. completion date: February 2011

Study information

• Verified date: April 2011
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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)

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• LY2452473
Administered orally as a liquid suspension

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary and fecal excretion of radioactivity over time expressed as a percentage of the total radioactive dose administered		baseline up to 22 days	No
Secondary	Plasma pharmacokinetics of LY2452473 and radioactivity maximum observed concentration (Cmax)		baseline up to 22 days	No
Secondary	Plasma pharmacokinetics of LY2452473 and radioactivity time of maximum observed concentration (tmax)		baseline up to 22 days	No
Secondary	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	No
Secondary	Relative abundance of LY2452473 and the metabolites of LY2452473 in urine and feces		baseline up to 22 days	No
Secondary	Relative abundance of LY2452473 and the metabolites of LY2452473 in plasma		baseline up to 22 days	No