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NCT Number: NCT02884089

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

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.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Dallas Clinical Research Unit

Dallas, Texas, 75247, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Abemaciclib

Drug

Administered orally

Other names: LY2835219

metformin

Drug

Administered orally

Iohexol

Drug

Administered intravenously (IV)

Placebo

Drug

Administered orally

Primary outcomes

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

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

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

    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 was evaluated.

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

    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 was evaluated.

Secondary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Effect of Abemaciclib on Metformin Pharmacokinetics and Iohexol Clearance

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Aug 30, 2016
Registry last updated
Jan 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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