Phase 1 Completed N=30 Randomized Basic Science

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

Healthy

Source: ClinicalTrials.gov NCT02482935 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2018

Primary outcomePrimary: 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 — 3940; 4950; 1630; 1910 nanograms x hours/mililiters (ng·h/mL)

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY 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	3940; 4950; 1630; 1910; 3180; 3410	—
PRIMARY Pharmacokinetics: Maximum Concentration (Cmax) for Both Fed and Fasted Periods for Abemaciclib and Major Metabolites	116; 159; 33.4; 41.4; 55.7; 61.0	—
SECONDARY Pharmacokinetics: Time to Maximum Concentration (Tmax) for Both Fed and Fasted Periods for Abemaciclib and Major Metabolites	8.00; 8.00; 6.00; 6.00; 8.02; 10.00	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02482935). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.