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A Study of Abemaciclib (LY2835219) in Healthy Participants With and Without Food.

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ClinicalTrials.gov Identifier: NCT02482935
Recruitment Status : Completed
First Posted : June 26, 2015
Last Update Posted : October 20, 2015
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The purpose of this study is to evaluate the amount of abemaciclib that reaches the blood stream and how long the body takes to get rid of it when given with and without food. In addition, the safety and tolerability of the study drug will be evaluated. Information about any side effects that may occur will also be collected. The study will last about 43 days for each participant, not including screening.

Condition or disease Intervention/treatment Phase
Healthy Drug: Abemaciclib Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effect of Food on the Pharmacokinetics of the Proposed Commercial Formulation of Abemaciclib in Healthy Subjects
Study Start Date : June 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Abemaciclib

Arm Intervention/treatment
Experimental: Abemaciclib High Fat Meal
Abemaciclib capsules administered once orally in the fed state.
Drug: Abemaciclib
Administered orally
Other Name: LY2835219

Experimental: Abemaciclib Fasted
Abemaciclib capsules administered once orally in the fasted state.
Drug: Abemaciclib
Administered orally
Other Name: LY2835219




Primary Outcome Measures :
  1. Pharmacokinetics: Area Under the Concentration Curve (AUC) for Both Fed and Fasted Periods for Abemaciclib [ Time Frame: Predose through 192 hours after administration of study drug in each period ]
  2. Pharmacokinetics: Maximum Concentration (Cmax) for Both Fed and Fasted Periods for Abemaciclib [ Time Frame: Predose through 192 hours after administration of study drug in each period ]

Secondary Outcome Measures :
  1. Pharmacokinetics: Time to Maximum Concentration (Tmax) for both Fed and Fasted Period for Abemaciclib [ Time Frame: Predose through 192 hours after administration of study drug in each period ]


Information from the National Library of Medicine

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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:

  • Are overtly healthy sterile males or sugically sterile or postmenopausal females
  • Have a body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m^2), inclusive

Exclusion Criteria:

  • Participated in a clinical trial involving investigational product within 30 days
  • Have known allergies to abemaciclib, related compounds or any components of the formulation, or history of significant atopy
  • 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 milliliter (mL) within the last month
  • Have an average weekly alcohol intake that exceeds 21 units per week (males up to age 65) and 14 units per week (males over 65 and females), or are unwilling to stop alcohol consumption 48 hours prior to each admission until collection of the last PK sample in each period
  • Are unwilling to refrain from consuming xanthine-containing food and drink from 48 hours prior to admission until collection of the last pharmacokinetic (PK) sample in each period
  • Are currently or have been smokers or users of tobacco or nicotine replacement products within the 6 months prior to admission or have a positive urine cotinine test
  • Are unwilling to comply with the dietary requirements/restrictions during the study: Consume only the meals provided during the inpatient stays and refrain from eating any food or drinking any beverages containing grapefruit, grapefruit juice, grapefruit-containing products, Seville oranges, star fruit or star fruit juice, pomelo, or commercial apple juice or orange juice for at least 2 weeks prior to the first dose until the final PK sample is collected

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): NCT02482935


Locations
United States, Florida
Covance Clinical Research Unit
Daytona Beach, Florida, United States, 32117
United States, Texas
Covance Clinical Research Unit
Dallas, Texas, United States, 75247
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02482935     History of Changes
Other Study ID Numbers: 15536
I3Y-MC-JPBU ( Other Identifier: Eli Lilly and Company )
First Posted: June 26, 2015    Key Record Dates
Last Update Posted: October 20, 2015
Last Verified: October 2015