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A Study of LY2835219 in Healthy Participants

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ClinicalTrials.gov Identifier: NCT02059148
Recruitment Status : Completed
First Posted : February 11, 2014
Results First Posted : August 16, 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:
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: 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 : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of Food on the Pharmacokinetics of LY2835219 in Healthy Subjects
Study Start Date : February 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014
Arms and Interventions
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Arm Intervention/treatment
Experimental: LY2835219 Standard
Single oral dose of LY2835219 given with a standard meal in one of three study periods.
 Drug: LY2835219
Administered orally.
Other Name: abemaciclib
Experimental: LY2835219 Fasted
Single oral dose of LY2835219 given with no food in one of three periods.
 Drug: LY2835219
Administered orally.
Other Name: abemaciclib
Experimental: LY2835219 High-Fat
Single oral dose of LY2835219 given with a high fat meal in one of three periods.
 Drug: LY2835219
Administered orally.
Other Name: abemaciclib


Outcome Measures
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Primary Outcome Measures :
  1. Pharmacokinetics: Maximum Concentration (Cmax) of LY2835219 Fasted vs. High-Fat Arms [ Time Frame: 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 ]
  2. Pharmacokinetics: Area Under the Concentration Curve (0-t Last) [AUC(0-t Last)] of LY2835219 Fasted vs. High-Fat Arms [ Time Frame: 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 ]
  3. Pharmacokinetics: Time of Maximum Observed Concentration (Tmax) of LY2835219 Fasted vs. High-Fat Arms [ Time Frame: 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 Outcome Measures :
  1. Pharmacokinetics: Cmax of LY2835219 in Standard Meal Arm [ Time Frame: 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 ]
  2. Pharmacokinetics: AUC(0-tlast) of LY2835219 in Standard Meal Arm [ Time Frame: 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 ]
  3. Pharmacokinetics: Tmax of LY2835219 in Standard Meal Arm [ Time Frame: 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 ]
  4. Pharmacokinetics: Area Under the Concentration Curve (AUC 0-t Last) of LSN3106726 (M20) [ Time Frame: 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 ]
    Area under the concentration versus time curve from time zero to time t, where t is the last time point with a measurable concentration of LSN3106726 (M20), an active metabolite of LY2835219.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • 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

Exclusion Criteria:

  • 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
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): NCT02059148


Locations
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United States, Texas
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, United States, 75247
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: NCT02059148    
Other Study ID Numbers: 15175
I3Y-MC-JPBG ( Other Identifier: Eli Lilly and Company )
First Posted: February 11, 2014    Key Record Dates
Results First Posted: August 16, 2018
Last Update Posted: January 7, 2019
Last Verified: December 2018