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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03616795
Other study ID # 16303
Secondary ID I7S-MC-HBEE
Status Completed
Phase Phase 1
First received
Last updated
Start date August 9, 2018
Est. completion date November 5, 2018

Study information

Verified date November 2018
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date November 5, 2018
Est. primary completion date November 5, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 50 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
LY3154207
Administered orally
[14C]-LY3154207
Administered orally

Locations

Country Name City State
United States Covance Clinical Research Inc Madison Wisconsin

Sponsors (1)

Lead Sponsor Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Urinary Excretion of LY3154207 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered Urinary Excretion of LY3154207 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered Baseline through 552 hours after administration of study drug
Primary Fecal Excretion of LY3154207 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered Fecal Excretion of LY3154207 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered Baseline through 552 hours after administration of study drug
Secondary Pharmacokinetics: Maximum Concentration (Cmax) of LY3154207 Pharmacokinetics: Cmax of LY3154207 Predose through 144 hours after administration of study drug
Secondary Pharmacokinetics: Area Under the Concentration Time Curve From Time Zero to Infinity (AUC[0-8]) Pharmacokinetics: AUC(0-8) Predose through 144 hours after administration of study drug
Secondary Total Number of Metabolites Total Number of Metabolites Baseline through 552 hours after administration of study drug
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