A Study of [14C]-LY3023703 in Healthy Participants
Status: | Terminated |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 8/30/2018 |
Start Date: | October 2013 |
End Date: | October 2013 |
Disposition of [14C]-LY3023703 Following Oral Administration in Healthy Subjects
This type of study is called a radiolabeled study. For this study, LY3023703 (study drug) has
been specially prepared to contain radiolabeled carbon [14C]. [14C] is a naturally occurring
radioactive form of the element carbon. This study will help understand how the drug appears
in the blood, urine, and stool after it is administered to healthy men. Information about any
side effects that may occur will also be collected. This study will last up to 15 days for
each participant, not including screening. Screening is required within 28 days prior to the
start of the study.
been specially prepared to contain radiolabeled carbon [14C]. [14C] is a naturally occurring
radioactive form of the element carbon. This study will help understand how the drug appears
in the blood, urine, and stool after it is administered to healthy men. Information about any
side effects that may occur will also be collected. This study will last up to 15 days for
each participant, not including screening. Screening is required within 28 days prior to the
start of the study.
Inclusion Criteria:
- Participants will either be sterile or, if sexually active, agree to use approved
methods of contraception from the day before dosing until 3 months after the follow-up
assessment
- Participants will refrain from sperm donation from the day before dosing until 3
months after the follow-up assessment
- Have a body mass index (BMI) of 18.5 to 32.0 kilogram per meter square (kg/m^2)
- Have clinical laboratory test results within normal reference range for the population
or investigator site, or results with acceptable deviations that are judged to be not
clinically significant by the investigator
- Have given written informed consent approved by Lilly and the IRB governing the site
Exclusion Criteria:
- Are currently enrolled in, have participated, within the last 30 days, in a clinical
trial involving an investigational product, or are concurrently enrolled in any other
type of medical research judged not to be scientifically or medically compatible with
this study
- Are participants who have previously completed or withdrawn from this study or any
other study investigating LY3023703, and have previously received the investigational
product
- Have known allergies to LY3023703, related compounds or any components of the
formulation, or history of significant atopy
- Have recent or ongoing gastrointestinal (GI) symptoms or illnesses, have a history of
GI bleeding or perforation, related to previous nonsteroidal anti-inflammatory drug
(NSAID) or cyclooxygenase (COX)2 inhibitor therapy or have active or history of
recurrent peptic ulcer/hemorrhage (2 or more distinct episodes of proven ulceration or
bleeding)
- Have a history of intolerance to NSAIDs or aspirin
- Regularly use known drugs of abuse and/or show positive findings on urinary drug
screening
- Show evidence of alanine aminotransferase or aspartate aminotransferase levels above
the normal ranges, confirmed on repeat, or a history of elevated and abnormal liver
tests
- Have intended use of over-the-counter medications or prescription medication within 14
days prior to dosing. Also within 30 days prior to dosing, any drugs and dietary items
that are known inducers or inhibitors of cytochrome P450 (CYP) 3A or CYP2J2 or other
drugs that may affect the disposition of LY3023703 or increase risk for complications
from the study
- Have consumed herbal supplements within 14 days prior to admission or 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 milliliter (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)
- A positive alcohol breathalyzer test
- A positive cotinine test
- Are unwilling to refrain from consuming xanthine-containing food and drink from 48
hours prior to admission until discharge from the Clinical Research Unit (CRU)
- Have a defecation pattern less than once per 2 days or acute constipation within 3
weeks of the day before dosing
- In the opinion of the investigator or sponsor, are unsuitable for inclusion in the
study
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