CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 40 enrolled
Drug / intervention
Abemaciclib +3 moredrug
Likely dose
Not stated in record
Key inclusion· 2
  • Healthy surgically sterile or postmenopausal females and sterile males
  • BMI between 18 and 32 kg/m², inclusive
Key exclusion· 3
  • Known allergies to abemaciclib, metformin, iodine, iohexol, or related compounds
  • Regular use of drugs of abuse or positive urinary drug screen
  • HIV, hepatitis B, or hepatitis C seropositivity

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02884089
NCT02884089Phase 1Completed

Effect of Abemaciclib on Metformin Pharmacokinetics and Iohexol Clearance

Eli Lilly and Company·interventional·Posted Aug 30, 2016·Updated Jan 4, 2019

In Brief

A Phase 1 clinical trial evaluating Abemaciclib, Metformin, and 2 other interventions for Healthy. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 30, 2016
Enrollment StartAug 1, 2016
Primary CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 9.8 years ago

Interventions

Abemaciclibdrug

Administered orally

Metformindrug

Administered orally

Iohexoldrug

Administered intravenously (IV)

Placebodrug

Administered orally