A Study of LY3337641 in Healthy Male Participants
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 11/19/2016 |
| Start Date: | September 2016 |
| End Date: | November 2016 |
Disposition of [¹⁴C]-LY3337641 Following Oral Administration in Healthy Male Subjects
The purpose of this study is to measure how much LY3337641 gets into the bloodstream and how
long it takes the body to get rid of it. In addition, the safety and tolerability of the
study drug will be evaluated.
Participants will be admitted to a clinical research unit (CRU) the day before dosing.
Participants remain confined to the CRU for at least 7 days. Participants may be discharged
from the CRU any time after 7 days post-dose (Day 8), and up to a maximum of 21 days
post-dose (Day 22).
This study will last approximately 30 days for each participant, not including screening.
Screening is required within 28 days prior to the start of the study.
long it takes the body to get rid of it. In addition, the safety and tolerability of the
study drug will be evaluated.
Participants will be admitted to a clinical research unit (CRU) the day before dosing.
Participants remain confined to the CRU for at least 7 days. Participants may be discharged
from the CRU any time after 7 days post-dose (Day 8), and up to a maximum of 21 days
post-dose (Day 22).
This study will last approximately 30 days for each participant, not including screening.
Screening is required within 28 days prior to the start of the study.
Inclusion Criteria:
- Overtly healthy males, as determined by medical history and physical examination
- Have a body mass index (BMI) between 18.5 and 32.0 kilograms per meter squared
(kg/m²)
- Have clinical laboratory test results within normal reference range for the
population or investigative site, or results with acceptable deviations that are
judged to be not clinically significant by the investigator
- Have venous access sufficient to allow for blood sampling as per the protocol
- Are able and willing to give signed informed consent
- Generally have a minimum of 1 bowel movement per day
Exclusion Criteria:
- Have participated, within the last 30 days, in a clinical trial involving an
investigational product. If the previous investigational product has a long
half-life, 3 months or 5 half-lives (whichever is longer, if known) should have
passed
- Have a significant history of or current cardiovascular, respiratory, hepatic, renal,
gastrointestinal (GI) (cholecystectomy not acceptable), endocrine, hematological,
dermatologic, or neurological disorders capable of significantly altering the
absorption, metabolism, or elimination of drugs; of constituting a risk when taking
the investigational product; or of interfering with the interpretation of data
- Regularly use known drugs of abuse and/or show positive findings on urinary drug
screening
- Have used or intend to use over-the-counter or prescription medication, including
herbal medications, within 14 days prior to dosing
- Have donated blood of more than 500 milliliter (mL) within the month prior to
screening
- Have an average weekly alcohol intake that exceeds 21 units per week, and are
unwilling to stop alcohol consumption for 48 hours prior to admission, and while
resident in the clinical research unit (CRU)
- In the opinion of the investigator or sponsor, are unsuitable for inclusion in the
study
- Have had exposure to significant diagnostic, therapeutic, or employment related
radiation within 12 months prior to dosing (serial x-ray or computed tomography
scans, barium meal, current employment in a job requiring radiation exposure
monitoring)
- 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 (per 21 CFR 361.1): less
than 5000 Milli-rem (mrem) /year whole body annual exposure
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