A Study of Carbon-14-Labeled LY2835219 ([^14C]-LY2835219) in Healthy Participants

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT01913314

Run by

Eli Lilly and Company

People needed

6

Starts

2013-08-01

Expected to finish

2013-10-01

Last updated by the study team

2019-01-07

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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