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

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Abemaciclib; Drug: Placebo; Drug: Iohexol; Drug: Metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02884089

16536

I3Y-MC-JPCK (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 40 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) 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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40 participants in 4 patient groups, including a placebo group

Placebo + Metformin

Placebo Comparator group

Description:

Single dose of placebo administered orally followed by a single dose of metformin administered orally in one of four study periods.

Treatment:

Drug: Placebo

Drug: Metformin

Abemaciclib + Metformin

Experimental group

Description:

Single dose of abemaciclib administered orally followed by a single dose of metformin administered orally in one of four study periods.

Treatment:

Drug: Metformin

Drug: Abemaciclib

Placebo + Iohexol

Placebo Comparator group

Description:

Single dose of placebo administered orally followed by a single dose of iohexol administered intravenously (IV) in one of four study periods.

Treatment:

Drug: Placebo

Drug: Iohexol

Abemaciclib + Iohexol

Experimental group

Description:

Single dose of abemaciclib administered orally followed by a single dose of iohexol administered intravenously (IV) in one of four study periods.

Treatment:

Drug: Iohexol

Drug: Abemaciclib