A Study of Abemaciclib in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Abemaciclib Capsules (Reference Formulation); Drug: Abemaciclib Tablet (Test Formulation)

• Registration Number: NCT02672423
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-01
• Study First Submitted QC: 2016-02-01
• Study First Posted: 2016-02-03
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Results First Submitted: 2017-10-27
• Results First Submitted QC: 2017-10-27
• Results First Posted: 2018-08-03
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-13
• Last Update Posted: 2019-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Abemaciclib Part B	Abemaciclib Capsules (Reference Formulation)	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.
Abemaciclib Part A	Abemaciclib Capsules (Reference Formulation)	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.
Abemaciclib Part A	Abemaciclib Tablet (Test Formulation)	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.
Abemaciclib Part B	Abemaciclib Tablet (Test Formulation)	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.
Abemaciclib Part C	Abemaciclib Tablet (Test Formulation)	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.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞])	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	Area under the concentration versus time curve from zero to infinity.
PK: Maximum Observed Drug Concentration (Cmax)	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	Maximum observed drug concentration.

Trial Locations

Locations (2)

Daytona Beach Clinical Research Unit; 🇺🇸 Daytona Beach, Florida, United States

Evansville Clinical Research Unit; 🇺🇸 Evansville, Indiana, United States