NCT02327143

Brief Summary

The aim of this study is to compare how much of the study drug gets into the blood stream when it is given as a single oral dose and as an intravenous infusion (given directly into a vein via a small needle). The study will also provide information on how well the study drug is tolerated when given as a capsule in combination with giving it intravenously, and information on any changes in heart function. The study will last about 10 days. Screening is required within 28 days before study drug is given.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_1 healthy-volunteers

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 30, 2014

Completed
2 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

August 6, 2018

Completed
Last Updated

August 6, 2018

Status Verified

October 1, 2017

Enrollment Period

1 month

First QC Date

December 23, 2014

Results QC Date

October 27, 2017

Last Update Submit

October 27, 2017

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Zero to Infinity [AUC(0-∞)] of LY2835219 and ¹³C₈-LY2835219

    Predose, 2, 4, 6, 6.25, 6.5, 6.75, 7.25, 8.25,10, 12, 14, 24, 48, 72, 96,120, 144, 168,192 Hours Postdose

Secondary Outcomes (2)

  • PK: Maximum Observed Concentration (Cmax) of LY2835219

    Predose, 2, 4, 6, 6.25, 6.5, 6.75, 7.25, 8.25,10, 12, 14, 24, 48, 72, 96,120, 144, 168,192 Hours Postdose

  • PK: Time of Maximum Observed Drug Concentration (Tmax) of LY2835219

    Predose, 2, 4, 6, 6.25, 6.5, 6.75, 7.25, 8.25,10, 12, 14, 24, 48, 72, 96,120, 144, 168,192 Hours Postdose

Study Arms (2)

200 mg LY2835219

EXPERIMENTAL

200 mg LY2835219 administered orally on day 1.

Drug: LY2835219

0.4 mg ¹³C₈-LY2835219

EXPERIMENTAL

0.4 mg ¹³C₈-LY2835219 given intravenously (IV) for 15 minutes, starting approximately 6 hours after the oral dose.

Drug: ¹³C₈-LY2835219

Interventions

LY2835219DRUG

Administered orally

200 mg LY2835219
¹³C₈-LY2835219DRUG

Administered IV

0.4 mg ¹³C₈-LY2835219

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Overtly healthy sterile males or surgically sterile females or postmenopausal females
  • Have a body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m\^2)
  • Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site.
  • Participants who are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures

You may not qualify if:

  • Have participated in a clinical trial involving investigational product within the last 90 days
  • Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
  • Have an abnormal blood pressure
  • Show evidence of human immunodeficiency virus (HIV), hepatitis B or hepatitis C
  • Have donated blood of more than 500 milliliters (mL) within the last month
  • Have consumed any sensitive CYP2B6 substrate drugs, any CYP3A4 inhibitor or any CYP3A inducer, herbal supplements, grapefruits or grapefruit containing products, Seville oranges or Seville orange containing products, star fruits or star fruit containing products within 2 weeks prior to dosing or intend to consume during the study
  • Regularly use known drugs of abuse and/or show positive findings on urinary drug screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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.

Leeds, LS2 9LH, United Kingdom

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
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2014

First Posted

December 30, 2014

Study Start

January 1, 2015

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

August 6, 2018

Results First Posted

August 6, 2018

Record last verified: 2017-10

Locations

GB(1)