A Study of the Effect of Abemaciclib on Metformin and Iohexol in Healthy Participants

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT02884089

Run by

Eli Lilly and Company

People needed

40

Starts

2016-08-01

Expected to finish

2016-12-01

Last updated by the study team

2019-01-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Dallas Clinical Research Unit — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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