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A Study of LY2835219 in Healthy Participants

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ClinicalTrials.gov Identifier: NCT02256267
Recruitment Status : Completed
First Posted : October 3, 2014
Results First Posted : August 2, 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:

The aim of this two-period 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 when it is given as a single oral dose in combination with rifampin (a Food and Drug Administration [FDA] approved antibiotic that is used to treat tuberculosis, a bacterial infection that mainly affects the lungs, and other infections). Each participant will complete both study periods.

The study will last about 34 days. Screening is required within 28 days before study drug is given.


Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: LY2835219 Drug: Rifampin 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effects of CYP3A Induction by Rifampin on the Pharmacokinetics of LY2835219 and Its Metabolites in Healthy Subjects
Study Start Date : October 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Rifampin

Arms and Interventions
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Arm Intervention/treatment
Experimental: LY2835219
Single oral dose of LY2835219
 Drug: LY2835219
Administered orally
Other Name: abemaciclib
Experimental: LY2835219 + Rifampin
Single oral dose of LY2835219 with rifampin orally, once daily for 14 days
 Drug: LY2835219
Administered orally
Other Name: abemaciclib

Drug: Rifampin
Administered orally


Outcome Measures
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Primary Outcome Measures :
  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2835219 [ Time Frame: Period 1: Day 1- Predose,1, 2, 4, 6, 8, 10 hours, Days 2-9: 24, 48, 72, 96, 120, 144, 168, and 192 hours; Period 2: Day 7- Predose,1, 2, 4, 6, 8, 10 hours, Days 8-15: 24, 48, 72, 96, 120, 144, 168, 192 hours ]
  2. PK: Area Under the Concentration Time Curve AUC(0-∞) of LY2835219 [ Time Frame: Period 1: Day 1- Predose,1, 2, 4, 6, 8, 10 hours, Days 2-9: 24, 48, 72, 96, 120, 144, 168, and 192 hours; Period 2: Day 7- Predose,1, 2, 4, 6, 8, 10 hours, Days 8-15: 24, 48, 72, 96, 120, 144, 168, 192 hours ]

Eligibility Criteria
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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:

  • 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)

Exclusion Criteria:

  • Have participated in a clinical trial involving investigational product within the last 30 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 used or intend to use over-the-counter or prescription medication including herbal medications within 7 days prior to dosing or during the study
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): NCT02256267


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: NCT02256267    
Other Study ID Numbers: 15174
I3Y-MC-JPBF ( Other Identifier: Eli Lilly and Company )
First Posted: October 3, 2014    Key Record Dates
Results First Posted: August 2, 2018
Last Update Posted: January 7, 2019
Last Verified: December 2018
Additional relevant MeSH terms:
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Rifampin
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers