A Study of [¹⁴C]-LY3023414 in Healthy Participants



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:October 2015
End Date:November 2015

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Disposition of [¹⁴C]-LY3023414 Following Oral Administration in Healthy Subjects

This type of study is called a radiolabeled study. For this study, LY3023414 has been
specially prepared to contain the radioactive carbon atom [¹⁴C]. [¹⁴C] is a naturally
occurring radioactive form of the element carbon. Adding a low dose of radiation to the
study drug does not change how the drug works but helps to identify when the drug appears in
the blood, urine, breath, and stool after it is given. The study will last about 15 days for
each participant, not including screening. Screening is required within 28 days prior to
enrollment. This study is for research purposes only and is not intended to treat any
medical condition.


Inclusion Criteria:

- Healthy men or women

- Male participants: Will be sterile (including vasectomy), confirmed by
documentation. Men who are sexually active with a pregnant partner agree to use
a condom for 91 days from the time of dosing

- Female participants: Women not of childbearing potential due to surgical
sterilization (at least 6 months after hysterectomy with or without bilateral
oophorectomy or at least 6 months after tubal ligation) confirmed by medical
history or menopause. Postmenopausal women include women with spontaneous
amenorrhea for at least 12 months, not induced by a medical condition such as
anorexia nervosa and not taking medications during the amenorrhea that induced
the amenorrhea (eg, oral contraceptives, hormones, gonadotropin releasing
hormone, anti-estrogens, selective estrogen receptor modulators, or
chemotherapy) and a follicle-stimulating hormone level greater than 40 milli
international units per milliliter (mIU/mL)

- Have a body mass index (BMI) of 18.5 to 32.0 kilograms per meter square (kg/m²)

- Have clinical laboratory test results within normal reference range for the
population or investigator site

- Have venous access sufficient to allow for blood sampling

Exclusion Criteria:

- Have participated in a [¹⁴C]-study within the last 6 months prior to admission for
this study. The total 12-month exposure from this study and a maximum of one other
previous [¹⁴C]-study within 6 to 12 months of this study must be within the Code of
Federal Regulations (CFR) recommended levels considered safe: Less than 5000 millirem
(mrem)/year whole body exposure.

- Exposure to significant diagnostic, therapeutic, or employment-related radiation
within 12 months prior to dosing (eg, serial x-ray or computed tomography scans,
barium meal, current employment in a job requiring radiation exposure monitoring)

- Are participants who have previously completed or withdrawn from this study or any
other study investigating LY3023414, and have previously received the investigational
product

- Have known allergies to LY3023414, related compounds, or any components of the
formulation

- Regularly use known drugs of abuse and/or show positive findings on urinary drug
testing

- Show evidence of human immunodeficiency virus (HIV) infection and/or positive human
HIV antibodies

- Show evidence of hepatitis C and/or positive hepatitis C antibody

- Show evidence of hepatitis B and/or positive hepatitis B surface antigen

- Intend to use over-the-counter or prescription medication within 7 days prior to
dosing

- Have donated blood of more than 500 milliliter (mL) within the last month

- Have an average weekly alcohol intake that exceeds 21 units per week, or are
unwilling to stop alcohol consumption from 48 hours prior to admission and while
resident in the Clinical Research Unit (CRU)

- Have consumed herbal supplements, grapefruits or grapefruit-containing products,
Seville oranges or Seville orange-containing products, star fruit or star
fruit-containing products within 7 days prior to dosing or intend to consume during
the study

- Are unwilling to refrain from consuming xanthine-containing food and drink from 48
hours prior to admission until discharge from the CRU

- Have a defecation pattern less than once per day or acute constipation within 3 weeks
prior to admission

- Have a history of clinically significant adverse drug reactions or "drug allergy" to
more than 3 types of systemically administered medications
We found this trial at
1
site
Madison, Wisconsin 53704
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mi
from
Madison, WI
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