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

NCT01913314 | Completed Phase 1 Results

• 2 other identifiers: 14930I3Y-MC-JPBD
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Urinary and Fecal Excretion of LY2835219-Related Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

  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.

  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

Secondary Outcomes (9)

• Plasma Pharmacokinetics (PK) of LY2835219 and Metabolite of LY2835219: Maximum Observed Concentration (Cmax)

  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

  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)

  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)]

  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)

  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

Study Arms (1)

[^14C]-LY2835219

EXPERIMENTAL

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

Drug: [^14C]-LY2835219

Interventions

[^14C]-LY2835219 DRUG

Administered as oral solution

Also known as: abemaciclib

[^14C]-LY2835219

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

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, 53704, United States

Location

MeSH Terms

Interventions

abemaciclib

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: July 30, 2013
• First Posted: August 1, 2013
• Study Start: August 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: January 7, 2019
• Results First Posted: August 7, 2018

Record last verified: 2018-12

Locations

US (1)