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

Eli Lilly and Company40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Healthy

Interventions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Metformin

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC\[0-∞\]) of Metformin was evaluated.

Time frame: Pre dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36 hours (h) post dose

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Metformin

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Metformin was evaluated.

Time frame: Pre dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36 hours (h) post dose

Pharmacokinetics (PK): Renal Clearance (CLr) of Metformin

Pharmacokinetics (PK): Renal Clearance (CLr) of Metformin was evaluated.

Time frame: Pre dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36 hours (h) post dose

Secondary Outcomes

Pharmacokinetics (PK): Renal Clearance (CLr) of Iohexol

Pharmacokinetics (PK): Renal Clearance (CLr) of Iohexol was evaluated.

Time frame: Pre infusion, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6 hours post infusion

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes