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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01275157
First received: January 10, 2011
Last updated: April 14, 2011
Last verified: April 2011
  Purpose

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 Intervention Phase
Healthy Volunteers
Drug: LY2452473
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Disposition of [14C]-LY2452473 Following Oral Administration in Healthy Human Subjects

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Urinary and fecal excretion of radioactivity over time expressed as a percentage of the total radioactive dose administered [ Time Frame: baseline up to 22 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma pharmacokinetics of LY2452473 and radioactivity maximum observed concentration (Cmax) [ Time Frame: baseline up to 22 days ] [ Designated as safety issue: No ]
  • Plasma pharmacokinetics of LY2452473 and radioactivity time of maximum observed concentration (tmax) [ Time Frame: baseline up to 22 days ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: baseline up to 22 days ] [ Designated as safety issue: No ]
  • Relative abundance of LY2452473 and the metabolites of LY2452473 in urine and feces [ Time Frame: baseline up to 22 days ] [ Designated as safety issue: No ]
  • Relative abundance of LY2452473 and the metabolites of LY2452473 in plasma [ Time Frame: baseline up to 22 days ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: January 2011
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2452473
15 mg, containing 100 micro curies of 14C labeled LY2452473 taken once only
Drug: LY2452473
Administered orally as a liquid suspension

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01275157

Locations
United States, Wisconsin
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
  More Information

No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT01275157     History of Changes
Other Study ID Numbers: 13276, I2N-MC-GPBF
Study First Received: January 10, 2011
Last Updated: April 14, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Absorption
Distribution
Metabolism
Excretion
Mass balance
Metabolic profile
Radiolabeled study
14C

ClinicalTrials.gov processed this record on April 17, 2014