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Study of LY3154207 in Healthy Participants

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ClinicalTrials.gov Identifier: NCT03616795
Recruitment Status : Completed
First Posted : August 6, 2018
Last Update Posted : November 26, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The main purpose of this study is to measure how much of the study drug gets into the bloodstream and how long it takes the body to get rid of it. This study will involve a single dose of 14C radiolabelled LY3154207. This means that a radioactive substance C14 will be incorporated into the study drug, to investigate the study drug and its breakdown products, to find out how much of these pass from blood into urine, feces and expired air. The study will last about 4 weeks. Screening is required within 28 days prior to the start of the study and follow up is required approximately 7 days after discharge.

Condition or disease Intervention/treatment Phase
Healthy Drug: LY3154207 Drug: [14C]-LY3154207 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Disposition of [14C]-LY3154207 Following Oral Administration in Healthy Male Subjects
Actual Study Start Date : August 9, 2018
Actual Primary Completion Date : November 5, 2018
Actual Study Completion Date : November 5, 2018

Arm Intervention/treatment
Experimental: LY3154207 and [14C]-LY3154207
A single dose of LY3154207 and [14C]-LY3154207administered orally.
Drug: LY3154207
Administered orally

Drug: [14C]-LY3154207
Administered orally




Primary Outcome Measures :
  1. Urinary Excretion of LY3154207 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered [ Time Frame: Baseline through 552 hours after administration of study drug ]
    Urinary Excretion of LY3154207 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered

  2. Fecal Excretion of LY3154207 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered [ Time Frame: Baseline through 552 hours after administration of study drug ]
    Fecal Excretion of LY3154207 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered


Secondary Outcome Measures :
  1. Pharmacokinetics: Maximum Concentration (Cmax) of LY3154207 [ Time Frame: Predose through 144 hours after administration of study drug ]
    Pharmacokinetics: Cmax of LY3154207

  2. Pharmacokinetics: Area Under the Concentration Time Curve From Time Zero to Infinity (AUC[0-∞]) [ Time Frame: Predose through 144 hours after administration of study drug ]
    Pharmacokinetics: AUC(0-∞)

  3. Total Number of Metabolites [ Time Frame: Baseline through 552 hours after administration of study drug ]
    Total Number of Metabolites



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Have a body mass index (BMI) of 19 to 32.0 kilogram per meter square (kg/m²)
  • Are 18 to 50 years old, inclusive, at the time of screening

Exclusion Criteria:

  • 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
  • Are unwilling to refrain from consuming caffeine- or xanthine-containing food and drink from 48 hours prior to admission and while resident in the CRU
  • 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 participated in a [14C]-study within the last 4 to 6 months prior to admission for this study. The total 12-month exposure from this study and a maximum of 1 other previous [14C]-study within 6 to 12 months of this study (if the previous studies' radiation exposure is not known) or a maximum of 2 other previous [14C]-studies within 4 to 12 months of this study
  • Have a history of clinically significant adverse drug reactions or "drug allergy" to more than 3 types of systemically administered medications (all penicillins and cephalosporins may be considered 1 type of medication for this purpose)

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): NCT03616795


Locations
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United States, Wisconsin
Covance Clinical Research Inc
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03616795    
Other Study ID Numbers: 16303
I7S-MC-HBEE ( Other Identifier: Eli Lilly and Company )
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No