Overview

This trial has been completed.

Condition healthy
Treatments abemaciclib capsules (reference formulation), abemaciclib tablet(s) (test formulation)
Phase phase 1
Sponsor Eli Lilly and Company
Start date February 2016
End date October 2016
Trial size 86 participants
Trial identifier NCT02672423, 16169, I3Y-MC-JPCC

Summary

The purpose of this study is to measure how much abemaciclib gets into the blood stream and how long it takes the body to get rid of it when given as capsules versus a tablet(s). The effect of a high fat meal on the tablet formulation will also be evaluated. In addition, the tolerability of abemaciclib tablet and capsule formulations will be evaluated. Information about any side effects that may occur will also be collected.

This study has 3 parts. Parts A and C will last about 44 days including follow-up. Part B will last about 60 days including follow-up. Screening may occur up to 28 days before the first dose of study drug. Participants are only allowed to enroll in one part.

This study is for research purposes only and is not intended to treat any medical condition.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification bio-equivalence study
Intervention model crossover assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
Single oral dose of abemaciclib tablet (test formulation) or abemaciclib capsules (reference formulation) on Day 1 in each of 2 periods.
abemaciclib capsules (reference formulation) LY2835219
Administered orally
abemaciclib tablet(s) (test formulation) LY2835219
Administered orally
(Experimental)
Single oral dose of abemaciclib tablet(s) (test formulation) or abemaciclib capsules (reference formulation) on Day 1 in each of 3 periods.
abemaciclib capsules (reference formulation) LY2835219
Administered orally
abemaciclib tablet(s) (test formulation) LY2835219
Administered orally
(Experimental)
Single oral dose of abemaciclib tablet (test formulation) with or without a meal on Day 1 in each of 2 periods.
abemaciclib tablet(s) (test formulation) LY2835219
Administered orally

Primary Outcomes

Measure
Pharmacokinetics (PK): Area Under the Concentration versus Time Curve from Zero to Infinity (AUC[0-∞])
time frame: Predose through day 9 postdose
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax)
time frame: Predose through day 9 postdose

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Healthy surgically sterile or postmenopausal females and sterile males - Have a body mass index (BMI) 18 to 32 kilograms per square meter (kg/m²) Exclusion Criteria: - Have known allergies to abemaciclib, related compounds, or any components of the formulation - Regularly use known drugs of abuse and/or show positive findings on urinary drug screening - Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies - Show evidence of hepatitis C and/or positive hepatitis C antibody - Show evidence of hepatitis B and/or positive hepatitis B surface antigen

Additional Information

Official title A Bioequivalence Study Comparing Abemaciclib Capsule and Tablet Formulations and Effect of Food on Abemaciclib Tablet Pharmacokinetics in Healthy Subjects
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.