A Study of LY2784544 in Healthy Male Subjects

NCT01577355 | Completed Phase 1

• 2 other identifiers: 14484I3X-MC-JHTD
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single dose study of radiolabelled LY2784544 in healthy male subjects to study the absorption, distribution, metabolism and excretion of LY2784544. This study is for research purposes only and is not intended to treat any medical condition.

Conditions

Healthy Male Volunteers

Outcome Measures

Primary Outcomes (1)

• Urinary and fecal excretion of LY2784544 radioactivity over time expressed as a percentage of the total radioactive dose administered

  Predose up to 14 days post dose

Secondary Outcomes (6)

• Plasma pharmacokinetics of LY2784544 and radioactivity maximum observed concentration (Cmax)

  Predose up to 14 days post dose

• Plasma pharmacokinetics of LY27854544 and radioactivity time of maximum observed concentration (tmax)

  Predose up to 14 days post dose

• Plasma pharmacokinetics of LY2784544 and radioactivity area under the concentration-time curve from time zero to the last timepoint with a measurable concentration (AUC 0 to tlast)

  Predose up to 14 days post dose

• Relative abundance of LY2784544 and the metabolites of LY2784544 in urine and feces

  Predose up to 14 days post dose

• Relative abundance of LY2784544 and the metabolites of LY2784544 in plasma

  Predose up to 14 days post dose

Study Arms (1)

[C14]-LY2784544

EXPERIMENTAL

Single 30 mg oral dose containing 100 micro curies of LY2784544

Radiation: Drug

Interventions

Drug RADIATION

Single 30 mg oral dose containing 100 micro curies of LY2784544

[C14]-LY2784544

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 the day before dosing until 3 months after the end of the study
• Have a body mass index (BMI) of 19 to 29 kg/m\^2, inclusive
• Have 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 (BP) and heart rate (sitting) as determined by the investigator
• Have venous access sufficient to allow for blood sampling as per the study requirements
• 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

You may not qualify if:

• Are currently enrolled in, have completed, or discontinued within the last 30 days from a clinical study 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 LY2784544 or related compounds
• Have previously completed or withdrawn from this study or any other study investigating LY2784544
• 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
• Have a history or evidence of significant active neuropsychiatric disease and in particular evidence of significant medical or psychiatric illness within the past 12 months or have suicidal risk at the time of screening in the opinion of the investigator
• Have any other condition that in the opinion of the investigator would preclude participation in the study
• 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
• Show evidence of hepatitis B and/or positive hepatitis B surface antigen
• Use of herbal preparations containing St. John's Wort, kava, garlic, ginger, gingko biloba, or guarana within 14 days prior to admission or at any time during the study
• Intent to use over-the-counter (OTC) medication or prescription medication within 7 days prior to dosing or at any time during the study
• Consumption of grapefruit or grapefruit-containing foods or grapefruit-containing juices, Seville oranges or Seville orange juices, and star fruit or star fruit juices within 7 days prior to dosing or at any time during the study
• Have an average weekly alcohol intake that exceeds 21 units per week or are unwilling to stop alcohol consumption for the duration of 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 admission 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 5000 millirems (mrem)/year whole body annual exposure

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Interventions

Pharmaceutical Preparations

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2012
• First Posted: April 13, 2012
• Study Start: April 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: July 3, 2012

Record last verified: 2012-07

Locations

US (1)