A Study of LY2940680 in Healthy Participants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01746745
First received: December 7, 2012
Last updated: March 14, 2013
Last verified: March 2013
  Purpose

This is a single dose study of radiolabelled LY2940680 taken by mouth in healthy participants to study how the body absorbs and removes LY2940680 from the blood. This study is for research purposes only and is not intended to treat any medical condition.


Condition Intervention Phase
Healthy Volunteers
Drug: [C14]-LY2940680
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Disposition of [14C]-LY2940680 Following Oral Administration in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Fecal Excretion of LY2940680 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered [ Time Frame: Predose up to 14 days postdose ] [ Designated as safety issue: No ]
  • Urinary Excretion of LY2940680 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered [ Time Frame: Predose up to 14 days postdose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma Pharmacokinetics of LY2940680 and Radioactivity Maximum Observed Concentration (Cmax) [ Time Frame: Predose up to 14 days postdose ] [ Designated as safety issue: No ]
  • Plasma Pharmacokinetics of LY2940680 and Radioactivity Time of Maximum Observed Concentration (Tmax) [ Time Frame: Predose up to 14 days postdose ] [ Designated as safety issue: No ]
  • Plasma Pharmacokinetics of LY2940680 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: Predose up to 14 days postdose ] [ Designated as safety issue: No ]
  • Relative Abundance of LY2940680 and the Metabolites of LY2940680 in Urine [ Time Frame: Predose up to 14 days postdose ] [ Designated as safety issue: No ]
  • Relative Abundance of LY2940680 and the Metabolites of LY2940680 in Plasma [ Time Frame: Predose up to 14 days postdose ] [ Designated as safety issue: No ]
  • Relative Abundance of LY2940680 and the Metabolites of LY2940680 in Feces [ Time Frame: Predose up to 14 days postdose ] [ Designated as safety issue: No ]

Estimated Enrollment: 8
Study Start Date: January 2013
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: [C14]-LY2940680
Single 100 mg of LY2940680 containing 100 micro curies of radioactivity
Drug: [C14]-LY2940680
Administered as solution by mouth

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Generally healthy sterile males or surgically sterile females or postmenopausal females, as determined by medical history and laboratory assessments
  • Have a body mass index (BMI) of 18.5 to 32.0 kilograms per meter squared (kg/m^2), inclusive

Exclusion Criteria:

  • Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
  • Have consumed herbal supplements, grapefruit juice, grapefruits, grapefruit containing products, Seville orange juice, Seville oranges, star fruit, or star fruit juice within 7 days prior to dosing or intend to consume during the study have donated blood of more than 500 milliliters (mL) within the last month
  • Have participated in a [14C]-study within the last 6 months prior to admission for this study
  • 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 pattern less than once per 2 days to expel feces from the bowel through the rectum or acute constipation within 3 weeks of the day prior to dose
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01746745

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 from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Madison, Wisconsin, United States, 53704
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: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01746745     History of Changes
Other Study ID Numbers: 14892, I4J-MC-HHBF
Study First Received: December 7, 2012
Last Updated: March 14, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 15, 2014