Phase 1
Completed N=40
A Study of the Effect of Abemaciclib on Metformin and Iohexol in Healthy Participants
Healthy
Source: ClinicalTrials.gov NCT02884089 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcomePrimary: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Metformin — 12100; 16800 Nanogram*Hour per Milliliter (ng*h/mL)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Metformin |
12100; 16800 | — |
| PRIMARY Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Metformin |
1550; 1940 | — |
| PRIMARY Pharmacokinetics (PK): Renal Clearance (CLr) of Metformin |
21.5; 11.9 | — |
| SECONDARY Pharmacokinetics (PK): Renal Clearance (CLr) of Iohexol |
89; 85.6 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02884089). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.