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OpenTrials
Completed

NCT Number: NCT02256267

A Study of LY2835219 in Healthy Participants

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY2835219

Drug

Administered orally

Other names: abemaciclib

Rifampin

Drug

Administered orally

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Effects of CYP3A Induction by Rifampin on the Pharmacokinetics of LY2835219 and Its Metabolites in Healthy Subjects

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Oct 3, 2014
Registry last updated
Jan 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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