A Study of Carbon-14-Labeled LY2835219 ([^14C]-LY2835219) in Healthy Participants
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 1/9/2019 |
| Start Date: | August 2013 |
| End Date: | October 2013 |
Disposition of [^14C]-LY2835219 Following Oral Administration in Healthy Subjects
This type of study is called a radiolabeled study. For this study, LY2835219 (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.
In addition, this study will also evaluate the safety and tolerability of a single dose of
LY2835219 when given to healthy participants. Information about any side effects that may
occur will also be collected.
This study will last about 3 weeks for each participant, not including screening.
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.
In addition, this study will also evaluate the safety and tolerability of a single dose of
LY2835219 when given to healthy participants. Information about any side effects that may
occur will also be collected.
This study will last about 3 weeks for each participant, not including screening.
Inclusion Criteria:
- Overtly healthy male or female participants as determined by medical history and
physical examination
- Male participants will be sterile
- Female participants will be surgically sterile or postmenopausal
- Have a body mass index (BMI) of 18 to 29 kilograms per square meter (kg/m^2)
- Have venous access sufficient to allow for blood sampling
Exclusion Criteria:
- Have a history or presence of cardiovascular, respiratory, hepatic, renal,
gastrointestinal, endocrine, hematological, or neurological disorders capable of
significantly altering the absorption, metabolism, or elimination of drugs; of
constituting a risk when taking the study medication; or of interfering with the
interpretation of data
- Gastrointestinal disorders causing clinically significant symptoms such as nausea,
vomiting, and diarrhea, or malabsorption syndromes
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