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MarketScreener Homepage  >  Equities  >  Nyse  >  Eli Lilly and Company    LLY

ELI LILLY AND COMPANY

(LLY)
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Disposition of -LY3214996 Following Oral Administration in Healthy Male Subjects: Clinical Trial Identifier NCT04033341

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08/14/2019 | 05:35pm EDT

2019 AUG 14 (NewsRx) -- By a News Reporter-Staff News Editor at Hepatitis Daily News -- Staff editors report on the newly launched clinical trial, NCT04033341, which has the following summary description: “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 LY3214996. This means that a radioactive substance, C14, will be incorporated into the study drug. The purposes are to investigate the study drug and its breakdown products and to find out how much of these pass from blood into urine and feces. The study will last up to six weeks.”

As a matter of record, on July 27, 2019, NewsRx staff editors report that the available information provided by Eli Lilly and Company on this trial include:

Tracking Information

Trial IdentifierNCT04033341
First Submitted DateJuly 24, 2019
First Posted DateJuly 26, 2019
Results First Submitted DateNot Provided
Results First Posted DateNot Provided
Last Update Submitted DateJuly 24, 2019
Last Update Posted DateJuly 26, 2019
Primary Completion DateOctober 28, 2019
Start DateAugust 1, 2019
Current Primary Outcome Measures•Urinary Excretion of LY3214996 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered [ Time Frame: Baseline through Day 8 after administration of study drug ] -- Urinary Excretion of LY3214996 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
•Fecal Excretion of LY3214996 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered [ Time Frame: Baseline through Day 8 after administration of study drug ] -- Fecal Excretion of LY3214996 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered
Current Secondary Outcome Measures•Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3214996 [ Time Frame: Predose through Day 8 after administration of study drug ] -- PK: Cmax of LY3214996
•PK: Area Under the Concentration Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3214996 [ Time Frame: Predose through Day 8 after administration of study drug ] -- PK: AUC(0-∞) of LY3214996
•Total Number of Metabolites of LY3214996 [ Time Frame: Baseline through 48 hours after administration of study drug ] -- Total Number of Metabolites of LY3214996
Other Outcome MeasuresNot Provided
Change HistoryComplete list of historical revisions of study NCT04033341

Descriptive Information

Brief TitleA Study of LY3214996 in Healthy Participants
Official TitleDisposition of [14C]-LY3214996 Following Oral Administration in Healthy Male Subjects
Brief SummaryThe 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 LY3214996. This means that a radioactive substance, C14, will be incorporated into the study drug. The purposes are to investigate the study drug and its breakdown products and to find out how much of these pass from blood into urine and feces. The study will last up to six weeks.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 1
Study DesignIntervention Model: Single Group Assignment
Primary Purpose: Basic Science
Masking: None (Open Label)
ConditionHealthy
Intervention•Drug: LY3214996
Administered orally
•Drug: [14C]-LY3214996
Administered orally
Study Arms•Experimental: LY3214996 + [14C]-LY3214996
A single dose of LY3214996 and [14C]-LY3214996 administered orally.
Interventions:
⚬Drug: LY3214996
⚬Drug: [14C]-LY3214996

Recruitment Information

Recruitment StatusNot yet recruiting
Estimated Enrollment8
Estimated Completion DateOctober 28, 2019
Primary Completion DateOctober 28, 2019 (Final data collection date for primary outcome measure)
EligibilityInclusion Criteria:
•Overtly health males
•Body mass index (BMI) of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive Exclusion Criteria:
•Females
•Male participants sexually active with a pregnant partner
•Are currently enrolled in a clinical study or have participated, within the last 30 days, in a clinical study
•Have participated in a radiolabeled drug study within the previous 4 months
•Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders
•Have a history of Gilbert’s syndrome
•Have history or presence of psychiatric disorders
•Show evidence of human immunodeficiency virus (HIV) infection
•Show evidence of hepatitis C
•Show evidence of hepatitis B
Sex/GenderSexes Eligible for Study: Male
Ages18 years to 65 years
Accepts Healthy VolunteersYes
ContactsPrimary contact: This is a single site clinical trial. 1-877-CTLILLY (1-877-285-4559) or, 1-317-615-4559, ClinicalTrials.gov@Lilly.com
Listed Location CountriesUnited States
Removed Location Countries

Administrative Information

NCT NumberNCT04033341
Other Study ID Numbers17199
I8S-MC-JUAD
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductStudies a U.S. FDA-Regulated Drug Product: Yes
Studies a U.S. FDA-Regulated Device Product: No
Plan to Share DataNo
Plan to Share Data (IPD) DescriptionNot Provided
Responsible PartyEli Lilly and Company
CollaboratorsNot Provided
InvestigatorsStudy 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
Information Provided ByEli Lilly and Company
Verification DateJuly 15, 2019

(Our reports deliver fact-based news of research and discoveries from around the world.)

Copyright © 2019 NewsRx LLC, Hepatitis Daily News, source Health Newsletters

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Sales 2019 22 276 M
EBIT 2019 6 192 M
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