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

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Status and phase

Completed
Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: [^14C]-LY2835219

Study type

Interventional

Funder types

Industry

Identifiers

NCT01913314
14930
I3Y-MC-JPBD (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

6 participants in 1 patient group

[^14C]-LY2835219
Experimental group
Description:
Single 150 milligram (mg) oral dose solution of LY2835219 containing 5 micro-curies of (µCi) \[\^14C\] labeled drug
Treatment:
Drug: [^14C]-LY2835219

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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