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

NCT ID: NCT02482935

Last Updated: 2019-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2015-09-30

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Abemaciclib High Fat Meal

Abemaciclib capsules administered once orally in the fed state.

Group Type: EXPERIMENTAL

Abemaciclib

Intervention Type: DRUG

Administered orally

Abemaciclib Fasted

Abemaciclib capsules administered once orally in the fasted state.

Group Type: EXPERIMENTAL

Abemaciclib

Intervention Type: DRUG

Administered orally

Interventions

Abemaciclib

Administered orally

Intervention Type: DRUG

Other Intervention Names

LY2835219

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

Covance Clinical Research Unit

Daytona Beach, Florida, United States

Covance Clinical Research Unit

Dallas, Texas, United States

Countries

United States

Other Identifiers

I3Y-MC-JPBU

Identifier Type: OTHER

Identifier Source: secondary_id

15536

Identifier Type: -

Identifier Source: org_study_id