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

• 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: Eli Lilly and Company
• Information provided by (Responsible Party): Eli Lilly and Company

Tracking Information

• First Submitted Date: July 30, 2013
• First Posted Date: August 1, 2013
• Results First Submitted Date: October 27, 2017
• Results First Posted Date: August 7, 2018
• Last Update Posted Date: January 7, 2019
• Study Start Date: August 2013
• Actual Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 27, 2017)

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.

• Original Primary Outcome Measures (submitted: July 31, 2013): Urinary and Fecal Excretion of LY2835219-Related Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered [ Time Frame: Pre-dose through Day 15 ]

Current Secondary Outcome Measures (submitted: October 27, 2017)

• 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 ]
• 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 ]
• 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 ]
• 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 ]
• 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).
• 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 ]
• 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 ]
• 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.
• 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.

Original Secondary Outcome Measures (submitted: July 31, 2013)

• Plasma Pharmacokinetics (PK) of LY2835219 and Metabolites and Radioactivity Maximum Observed Concentration (Cmax) [ Time Frame: Pre-dose through Day 15 ]
• Plasma Pharmacokinetics (PK) of LY2835219 and Metabolites and Radioactivity Time of Maximum Observed Concentration (tmax) [ Time Frame: Pre-dose through Day 15 ]
• Plasma Pharmacokinetics (PK) of LY2835219 and Metabolites and Radioactivity Area under the Concentration-Time Curve from Time Zero to the Last Timepoint with a Measurable Concentration (AUC 0 to tlast) [ Time Frame: Pre-dose through Day 15 ]
• Plasma Pharmacokinetics (PK) of LY2835219 and Metabolites and Radioactivity Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC 0-∞) [ Time Frame: Pre-dose through Day 15 ]
• Relative Abundance of LY2835219 and Metabolites of LY2835219 in Urine and Feces [ Time Frame: Pre-dose through Day 15 ]
• Relative Abundance of LY2835219 and Metabolites of LY2835219 in Plasma [ Time Frame: Pre-dose through Day 15 ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of Carbon-14-Labeled LY2835219 ([^14C]-LY2835219) in Healthy Participants
• Official Title: Disposition of [^14C]-LY2835219 Following Oral Administration in Healthy Subjects

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
• Condition: Healthy Volunteers

Intervention

Drug: [^14C]-LY2835219

Administered as oral solution

Other Name: abemaciclib

Study Arms

Experimental: [^14C]-LY2835219

Single 150 milligram (mg) oral dose solution of LY2835219 containing 5 micro-curies of (µCi) [^14C] labeled drug

Intervention: Drug: [^14C]-LY2835219

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 27, 2017): 6
• Original Estimated Enrollment (submitted: July 31, 2013): 8
• Actual Study Completion Date: October 2013
• Actual Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01913314
• Other Study ID Numbers: 14930; I3Y-MC-JPBD ( Other Identifier: Eli Lilly and Company )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Eli Lilly and Company
• Original Responsible Party: Same as current
• Current Study Sponsor: Eli Lilly and Company
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• 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

• PRS Account: Eli Lilly and Company
• Verification Date: December 2018