NCT02672423

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Feb 2016

Typical duration for phase_1 healthy

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

August 3, 2018

Completed
Last Updated

January 4, 2019

Status Verified

December 1, 2018

Enrollment Period

8 months

First QC Date

February 1, 2016

Results QC Date

October 27, 2017

Last Update Submit

December 13, 2018

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞])

    Area under the concentration versus time curve from zero to infinity.

    Parts A and C Periods 1 and 2; Part B Periods 1, 2, 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 96, 120,144,168 and 192 hours postdose

  • PK: Maximum Observed Drug Concentration (Cmax)

    Maximum observed drug concentration.

    Parts A and C Periods 1 and 2; Part B Periods 1, 2, 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 96, 120,144,168 and 192 hours postdose

Study Arms (3)

Abemaciclib Part A

EXPERIMENTAL

Reference formulation (R) = 3 x 50 mg abemaciclib capsules, Test formulation (T150) = 150 mg abemaciclib tablet administered orally on Day 1 in each of 2 periods.

Drug: Abemaciclib Capsules (Reference Formulation)Drug: Abemaciclib Tablet (Test Formulation)

Abemaciclib Part B

EXPERIMENTAL

R = 3 x 50 mg abemaciclib capsules, T150 = 150 mg abemaciclib tablet, Test Formulation 50 (T50) = 3 x 50 mg abemaciclib tablets administered orally on Day 1 in each of 3 periods.

Drug: Abemaciclib Capsules (Reference Formulation)Drug: Abemaciclib Tablet (Test Formulation)

Abemaciclib Part C

EXPERIMENTAL

T150 Fed and T150 Fasted = 150 mg abemaciclib tablet with a high-fat meal (T150 Fed) and then without a high-fat meal (T150 Fasted) on Day 1 in each of 2 periods administered orally.

Drug: Abemaciclib Tablet (Test Formulation)

Interventions

Abemaciclib Capsules (Reference Formulation)DRUG

Administered orally

Also known as: LY2835219
Abemaciclib Part AAbemaciclib Part B
Abemaciclib Tablet (Test Formulation)DRUG

Administered orally

Also known as: LY2835219
Abemaciclib Part AAbemaciclib Part BAbemaciclib Part C

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy surgically sterile or postmenopausal females and sterile males
  • Have a body mass index (BMI) 18 to 32 kilograms per square meter (kg/m²)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Daytona Beach Clinical Research Unit

Daytona Beach, Florida, 32117, United States

Location

Evansville Clinical Research Unit

Evansville, Indiana, 47710, United States

Location

MeSH Terms

Interventions

abemaciclib

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR
Expanded Access
Yes

Study Record Dates

First Submitted

February 1, 2016

First Posted

February 3, 2016

Study Start

February 1, 2016

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

January 4, 2019

Results First Posted

August 3, 2018

Record last verified: 2018-12

Locations

US(2)