NCT02059148

Brief Summary

Participants in this study will receive 3 single oral doses of LY2835219 at least 14 days apart. One dose will be given with a standard meal, one dose with a high-fat meal and one dose without food. The study will evaluate the effects of the standard and high-fat meals on how much drug gets into the bloodstream. Side effects will be documented. This study is approximately 43 days, not including screening. Screening is required within 28 days prior to the start of the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started Feb 2014

Typical duration 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

Study Start

First participant enrolled

February 1, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 11, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
4 years until next milestone

Results Posted

Study results publicly available

August 16, 2018

Completed
Last Updated

January 7, 2019

Status Verified

December 1, 2018

Enrollment Period

6 months

First QC Date

February 7, 2014

Results QC Date

October 27, 2017

Last Update Submit

December 13, 2018

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

  • Pharmacokinetics: Maximum Concentration (Cmax) of LY2835219 Fasted vs. High-Fat Arms

    Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period

  • Pharmacokinetics: Area Under the Concentration Curve (0-t Last) [AUC(0-t Last)] of LY2835219 Fasted vs. High-Fat Arms

    Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period

  • Pharmacokinetics: Time of Maximum Observed Concentration (Tmax) of LY2835219 Fasted vs. High-Fat Arms

    Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period

Secondary Outcomes (4)

  • Pharmacokinetics: Cmax of LY2835219 in Standard Meal Arm

    Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period

  • Pharmacokinetics: AUC(0-tlast) of LY2835219 in Standard Meal Arm

    Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period

  • Pharmacokinetics: Tmax of LY2835219 in Standard Meal Arm

    Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period

  • Pharmacokinetics: Area Under the Concentration Curve (AUC 0-t Last) of LSN3106726 (M20)

    Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period

Study Arms (3)

LY2835219 Standard

EXPERIMENTAL

Single oral dose of LY2835219 given with a standard meal in one of three study periods.

Drug: LY2835219

LY2835219 Fasted

EXPERIMENTAL

Single oral dose of LY2835219 given with no food in one of three periods.

Drug: LY2835219

LY2835219 High-Fat

EXPERIMENTAL

Single oral dose of LY2835219 given with a high fat meal in one of three periods.

Drug: LY2835219

Interventions

LY2835219DRUG

Administered orally.

Also known as: abemaciclib
LY2835219 FastedLY2835219 High-FatLY2835219 Standard

Eligibility Criteria

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

You may qualify if:

  • Healthy sterile males or surgically sterile or postmenopausal females
  • Have a body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m\^2), inclusive, at screening
  • Are able to eat a high-fat, high-calorie meal

You may not qualify if:

  • Participated in a clinical trial involving investigational product within 30 days
  • Abnormal blood pressure
  • 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 donated blood of more than 500 milliliter (mL) within the last month
  • Show evidence of human immunodeficiency virus, hepatitis B or hepatitis C

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.

Dallas, Texas, 75247, 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
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR
Expanded Access
Yes

Study Record Dates

First Submitted

February 7, 2014

First Posted

February 11, 2014

Study Start

February 1, 2014

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

January 7, 2019

Results First Posted

August 16, 2018

Record last verified: 2018-12

Locations

US(1)