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

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ClinicalTrials.gov Identifier: NCT01913314
Recruitment Status : Completed
First Posted : August 1, 2013
Results First Posted : August 7, 2018
Last Update Posted : January 7, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: [^14C]-LY2835219 Phase 1

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Disposition of [^14C]-LY2835219 Following Oral Administration in Healthy Subjects
Study Start Date : August 2013
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013
Arms and Interventions
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Arm Intervention/treatment
Experimental: [^14C]-LY2835219
Single 150 milligram (mg) oral dose solution of LY2835219 containing 5 micro-curies of (µCi) [^14C] labeled drug
 Drug: [^14C]-LY2835219
Administered as oral solution
Other Name: abemaciclib


Outcome Measures
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Primary Outcome Measures :
  1. Urinary and Fecal Excretion of LY2835219-Related Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered [ Time Frame: Predose up to Day 14 postdose; Fecal samples collected at 24-hour (h) intervals; Urine collected at 0 to 6 h, 6 to 12 h, and 12 to 24 h postdose and at 24-h intervals thereafter up to Day 14 postdose ]
    The percentage of the total radioactive dose administered that was excreted in urine or feces = (amount of radioactive dose recovered in urine or feces / total radioactive dose administered) * 100.


Secondary Outcome Measures :
  1. Plasma Pharmacokinetics (PK) of LY2835219 and Metabolite of LY2835219: Maximum Observed Concentration (Cmax) [ Time Frame: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose ]
  2. Plasma PK of Radioactivity: Cmax [ Time Frame: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose ]
  3. Plasma PK of LY2835219, Metabolite of LY2835219, and Radioactivity: Time of Maximum Observed Concentration (Tmax) [ Time Frame: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose ]
  4. Plasma PK of LY2835219 and Metabolite of LY2835219: Area Under the Concentration-Time Curve From Time Zero to the Last Time Point With a Measurable Concentration [AUC(0-tlast)] [ Time Frame: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose ]
  5. Plasma PK of Radioactivity: AUC(0 to Tlast) [ Time Frame: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose ]
    The PK of radioactivity was measured as nanogram equivalents times hours per gram (ng Eq*h/g).

  6. Plasma PK of LY2835219 and Metabolite of LY2835219: Area Under the Concentration Versus Time Curve From Zero to Infinity [AUC(0-∞)] [ Time Frame: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose ]
  7. Plasma PK of Radioactivity: AUC(0-∞) [ Time Frame: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose ]
  8. Relative Abundance of LY2835219 and Metabolites of LY2835219 Eliminated in Urine and Feces [ Time Frame: Predose through 216 h postdose; Fecal samples collected at 24-h intervals ]
    The abundance (as percentage dose) of LY2835219 or its metabolites eliminated in feces is calculated as = (amount of LY2835219 or its metabolites recovered in feces / total amount administered) * 100. Due to low radioactivity of dose recovered in urine, further quantitative profiling of urine was not conducted.

  9. Relative Abundance of LY2835219 and Metabolites of LY2835219 in Plasma [ Time Frame: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose ]
    The relative abundance of LY2835219 or its metabolites in plasma were estimated based on AUC(0-∞) and reported as a percentage of total plasma radioactivity. The relative abundance of LY2835219 or its metabolites calculated as = [AUC (0-∞) of LY2835219 or its metabolites in plasma / AUC (0-∞) of total plasma radioactivity] * 100.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01913314


Locations
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United States, Wisconsin
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, 53704
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
More Information
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01913314    
Other Study ID Numbers: 14930
I3Y-MC-JPBD ( Other Identifier: Eli Lilly and Company )
First Posted: August 1, 2013    Key Record Dates
Results First Posted: August 7, 2018
Last Update Posted: January 7, 2019
Last Verified: December 2018