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A Study of Abemaciclib in Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02672423
Recruitment Status : Completed
First Posted : February 3, 2016
Results First Posted : August 3, 2018
Last Update Posted : January 4, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:

The purpose of this study is to measure how much abemaciclib gets into the blood stream and how long it takes the body to get rid of it when given as capsules versus a tablet(s). The effect of a high fat meal on the tablet formulation will also be evaluated. In addition, the tolerability of abemaciclib tablet and capsule formulations will be evaluated. Information about any side effects that may occur will also be collected.

This study has 3 parts. Parts A and C will last about 44 days including follow-up. Part B will last about 60 days including follow-up. Screening may occur up to 28 days before the first dose of study drug. Participants are only allowed to enroll in one part.

This study is for research purposes only and is not intended to treat any medical condition.


Condition or disease Intervention/treatment Phase
Healthy Drug: Abemaciclib Capsules (Reference Formulation) Drug: Abemaciclib Tablet (Test Formulation) Phase 1

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Bioequivalence Study Comparing Abemaciclib Capsule and Tablet Formulations and Effect of Food on Abemaciclib Tablet Pharmacokinetics in Healthy Subjects
Study Start Date : February 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Abemaciclib

Arm Intervention/treatment
Experimental: Abemaciclib Part A
Reference formulation (R) = 3 x 50 mg abemaciclib capsules, Test formulation (T150) = 150 mg abemaciclib tablet administered orally on Day 1 in each of 2 periods.
Drug: Abemaciclib Capsules (Reference Formulation)
Administered orally
Other Name: LY2835219

Drug: Abemaciclib Tablet (Test Formulation)
Administered orally
Other Name: LY2835219

Experimental: Abemaciclib Part B
R = 3 x 50 mg abemaciclib capsules, T150 = 150 mg abemaciclib tablet, Test Formulation 50 (T50) = 3 x 50 mg abemaciclib tablets administered orally on Day 1 in each of 3 periods.
Drug: Abemaciclib Capsules (Reference Formulation)
Administered orally
Other Name: LY2835219

Drug: Abemaciclib Tablet (Test Formulation)
Administered orally
Other Name: LY2835219

Experimental: Abemaciclib Part C
T150 Fed and T150 Fasted = 150 mg abemaciclib tablet with a high-fat meal (T150 Fed) and then without a high-fat meal (T150 Fasted) on Day 1 in each of 2 periods administered orally.
Drug: Abemaciclib Tablet (Test Formulation)
Administered orally
Other Name: LY2835219




Primary Outcome Measures :
  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) [ Time Frame: Parts A and C Periods 1 and 2; Part B Periods 1, 2, 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 96, 120,144,168 and 192 hours postdose ]
    Area under the concentration versus time curve from zero to infinity.

  2. PK: Maximum Observed Drug Concentration (Cmax) [ Time Frame: Parts A and C Periods 1 and 2; Part B Periods 1, 2, 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 96, 120,144,168 and 192 hours postdose ]
    Maximum observed drug concentration.



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 and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy surgically sterile or postmenopausal females and sterile males
  • Have a body mass index (BMI) 18 to 32 kilograms per square meter (kg/m²)

Exclusion Criteria:

  • Have known allergies to abemaciclib, related compounds, or any components of the formulation
  • Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
  • Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
  • Show evidence of hepatitis C and/or positive hepatitis C antibody
  • Show evidence of hepatitis B and/or positive hepatitis B surface antigen

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): NCT02672423


Locations
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United States, Florida
Daytona Beach Clinical Research Unit
Daytona Beach, Florida, United States, 32117
United States, Indiana
Evansville Clinical Research Unit
Evansville, Indiana, United States, 47710
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
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02672423    
Other Study ID Numbers: 16169
I3Y-MC-JPCC ( Other Identifier: Eli Lilly and Company )
First Posted: February 3, 2016    Key Record Dates
Results First Posted: August 3, 2018
Last Update Posted: January 4, 2019
Last Verified: December 2018