A Study of Abemaciclib in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02672423

16169

I3Y-MC-JPCC (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 127 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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127 participants in 3 patient groups

Abemaciclib Part A

Experimental group

Description:

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.

Treatment:

Drug: Abemaciclib Capsules (Reference Formulation)

Drug: Abemaciclib Tablet (Test Formulation)

Abemaciclib Part B

Experimental group

Description:

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.

Treatment:

Drug: Abemaciclib Capsules (Reference Formulation)

Drug: Abemaciclib Tablet (Test Formulation)

Abemaciclib Part C

Experimental group

Description:

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.

Treatment:

Drug: Abemaciclib Tablet (Test Formulation)