A Study of Abemaciclib in Healthy Participants
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/6/2019 |
| Start Date: | February 2016 |
| End Date: | October 2016 |
A Bioequivalence Study Comparing Abemaciclib Capsule and Tablet Formulations and Effect of Food on Abemaciclib Tablet Pharmacokinetics in Healthy Subjects
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.
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.
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
We found this trial at
2
sites
Evansville, Indiana 47710
Principal Investigator: Kelly Whitehurst
Phone: 812-474-5000
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Daytona Beach, Florida 32117
Principal Investigator: Melanie Fein
Phone: 386-366-6400
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