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Completed

NCT Number: NCT02482935

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit, Daytona Beach, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Are overtly 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

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

Treatment and study plan

Abemaciclib

Drug

Administered orally

Other names: LY2835219

Primary outcomes

  1. Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-inf]) for Both Fed and Fasted Periods for Abemaciclib and Major Metabolites

    Time frame: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 Hours Postdose in Each Period

  2. Pharmacokinetics: Maximum Concentration (Cmax) for Both Fed and Fasted Periods for Abemaciclib and Major Metabolites

    Time frame: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 Hours Postdose in Each Period

Secondary outcomes

  1. Pharmacokinetics: Time to Maximum Concentration (Tmax) for Both Fed and Fasted Periods for Abemaciclib and Major Metabolites

    Time frame: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 Hours Postdose in Each Period

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

The Effect of Food on the Pharmacokinetics of the Proposed Commercial Formulation of Abemaciclib in Healthy Subjects

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 26, 2015
Registry last updated
Jan 4, 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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