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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Metformin; Drug: Placebo; Drug: Abemaciclib; Drug: Iohexol

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75247
      • Dallas Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo + Metformin; Single dose of placebo administered orally followed by a single dose of metformin administered orally in one of four study periods.	Drug: Metformin; Administered orally; Drug: Placebo; Administered orally
Experimental: Abemaciclib + Metformin; Single dose of abemaciclib administered orally followed by a single dose of metformin administered orally in one of four study periods.	Drug: Metformin; Administered orally; Drug: Abemaciclib; Administered orally; Other Names: LY2835219
Placebo Comparator: Placebo + Iohexol; Single dose of placebo administered orally followed by a single dose of iohexol administered intravenously (IV) in one of four study periods.	Drug: Placebo; Administered orally; Drug: Iohexol; Administered intravenously (IV)
Experimental: Abemaciclib + Iohexol; Single dose of abemaciclib administered orally followed by a single dose of iohexol administered intravenously (IV) in one of four study periods.	Drug: Abemaciclib; Administered orally; Other Names: LY2835219; Drug: Iohexol; Administered intravenously (IV)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: August 25, 2016
• First Submitted That Met QC Criteria: August 25, 2016
• First Posted (Estimate): August 30, 2016

Study Record Updates

• Last Update Posted (Actual): January 4, 2019
• Last Update Submitted That Met QC Criteria: December 13, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: 16536; I3Y-MC-JPCK (Other Identifier: Eli Lilly and Company)