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Trial record 3 of 5 for:    LY3202626

A Study of [¹⁴C]-LY3202626 in Healthy Male Participants

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ClinicalTrials.gov Identifier: NCT02555449
Recruitment Status : Completed
First Posted : September 21, 2015
Last Update Posted : December 16, 2015
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:

The purpose of this study is to measure how much of the specially prepared study drug, LY3202626, containing radiolabeled carbon [¹⁴C] gets into the blood stream and how long it takes the body to get rid of it.

Information about any side effects that may occur will also be collected.

Participants will stay at a clinical research unit (CRU). The study will last about 28 days (check in to follow-up) for each participant.

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


Condition or disease Intervention/treatment Phase
Healthy Drug: [¹⁴C]-LY3202626 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Disposition of [¹⁴C]-LY3202626 Following Oral Administration in Healthy Male Subjects
Study Start Date : September 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Arm Intervention/treatment
Experimental: [¹⁴C]-LY3202626
Single oral dose of LY3202626 containing 100 micro curies of radioactivity
Drug: [¹⁴C]-LY3202626
Administered as solution by mouth




Primary Outcome Measures :
  1. Fecal Excretion of LY3202626 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered [ Time Frame: Pre-dose up to 22 days post-dose ]
  2. Urinary Excretion of LY3202626 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered [ Time Frame: Pre-dose up to 22 days post-dose ]

Secondary Outcome Measures :
  1. Plasma Pharmacokinetics of LY3202626 and Radioactivity Maximum Observed Concentration (Cmax) [ Time Frame: Pre-dose up to 22 days post-dose ]
  2. Plasma Pharmacokinetics of LY3202626 and radioactivity area under the concentration-time curve from time zero to infinity (AUC 0 to infinity) [ Time Frame: Pre-dose up to 22 days post-dose ]
  3. Plasma pharmacokinetics of LY3202626 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: Pre-dose up to 22 days post-dose ]
  4. Total number of metabolites representing at least 10% of the total radioactivity in plasma, urine and/or feces [ Time Frame: Pre-dose up to 22 days post-dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Are overtly healthy males, as determined by physical examination, clinical laboratory tests, medical history and electrocardiogram (ECG)
  • Have a body mass index (BMI) of 18.5 to 32.0 kilograms per meter squared (kg/m²) inclusive at screening

Exclusion Criteria:

  • Have participated in a [¹⁴C]-study within the last 6 months prior to admission for this study
  • Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
  • Have consumed grapefruits or grapefruit-containing products, Seville oranges or Seville orange-containing products, star fruits or star fruit-containing products within 7 days prior to dosing or intend to consume during the study
  • Have a history of constipation or have had acute constipation within 3 weeks prior to admission
  • Are currently or have been smokers or users of tobacco or nicotine replacement products within the 3 months prior to admission and/or have positive cotinine at screening or check-in
  • Exposure to significant diagnostic, therapeutic, or employment-related radiation within 12 months prior to dosing (e.g., serial x-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02555449


Locations
United States, Wisconsin
Covance Clinical Research Unit Inc.
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

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02555449     History of Changes
Other Study ID Numbers: 15566
I7X-EW-LLCC ( Other Identifier: Eli Lilly and Company )
First Posted: September 21, 2015    Key Record Dates
Last Update Posted: December 16, 2015
Last Verified: December 2015