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

Phase 1

Completed

Interventions: Drug: Metformin
Drug: Abemaciclib
Drug: Iohexol
Drug: Placebo

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Placebo + Metformin	Placebo	Single dose of placebo administered orally followed by a single dose of metformin administered orally in one of four study periods.
Placebo + Iohexol	Placebo	Single dose of placebo administered orally followed by a single dose of iohexol administered intravenously (IV) in one of four study periods.
Placebo + Metformin	Metformin	Single dose of placebo administered orally followed by a single dose of metformin administered orally in one of four study periods.
Abemaciclib + Metformin	Metformin	Single dose of abemaciclib administered orally followed by a single dose of metformin administered orally in one of four study periods.
Abemaciclib + Metformin	Abemaciclib	Single dose of abemaciclib administered orally followed by a single dose of metformin administered orally in one of four study periods.
Placebo + Iohexol	Iohexol	Single dose of placebo administered orally followed by a single dose of iohexol administered intravenously (IV) in one of four study periods.
Abemaciclib + Iohexol	Abemaciclib	Single dose of abemaciclib administered orally followed by a single dose of iohexol administered intravenously (IV) in one of four study periods.
Abemaciclib + Iohexol	Iohexol	Single dose of abemaciclib administered orally followed by a single dose of iohexol administered intravenously (IV) in one of four study periods.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Metformin	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): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC\[0-∞\]) of Metformin was evaluated.
Pharmacokinetics (PK): Renal Clearance (CLr) of Metformin	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 was evaluated.
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Metformin	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 was evaluated.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Renal Clearance (CLr) of Iohexol	Pre infusion, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6 hours post infusion	Pharmacokinetics (PK): Renal Clearance (CLr) of Iohexol was evaluated.