A Study of the Effect of Abemaciclib on Metformin and Iohexol in Healthy Participants
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/6/2019 |
| Start Date: | August 2016 |
| End Date: | December 2016 |
Effect of Abemaciclib on Metformin Pharmacokinetics and Iohexol Clearance
This study will look at how a single dose of abemaciclib will impact the body's ability to
get rid of two other drugs, metformin and iohexol. In addition, this study will evaluate the
effect of a single dose of abemaciclib on kidney function by measuring blood and urine
markers. Side effects will also be documented.
Each participant will complete four study periods. During each study period, participants
will stay in the clinical research unit for nine days and eight nights.
The study will last approximately 10 weeks, not including screening. Screening is required
within 28 days prior to the start of the study.
This study is for research purposes only and is not intended to treat any medical condition.
get rid of two other drugs, metformin and iohexol. In addition, this study will evaluate the
effect of a single dose of abemaciclib on kidney function by measuring blood and urine
markers. Side effects will also be documented.
Each participant will complete four study periods. During each study period, participants
will stay in the clinical research unit for nine days and eight nights.
The study will last approximately 10 weeks, not including screening. Screening is required
within 28 days prior to the start of the study.
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) between 18 and 32 kilograms per meter squared (kg/m²),
inclusive at screening
Exclusion Criteria:
- Have known allergies to abemaciclib, metformin, iodine, iohexol, 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 and/or positive antibodies of human immunodeficiency virus (HIV),
hepatitis B, or hepatitis C
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