drugset / Trial / NCT03655301

Effect of Copanlisib on Metformin Pharmacokinetics and Pharmacodynamics

NCT03655301

Phase 1 Completed 13 enrolled Bayer
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to learn about a drug-drug interaction. When two medications are taken together at the same time, one medication may change the activity of the other medication in the body - this is called a drug-drug interaction. This study is looking at the effect the Bayer study drug, copanlisib, has on metformin, a commonly used medication to treat diabetes. During the study, blood and urine samples will be collected and analyzed to learn about pharmacokinetics (how copanlisib changes metformin levels in the body) and pharmacodynamics (the effect metformin has on the body when taken together with copanlisib) when someone takes both copanlisib and metformin together.

Timeline

Start
2018-09-11
Primary completion
2018-11-12
Completion
2019-02-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Copanlisib Small molecule 60 mg Intravenous
Subject Metformin Small molecule 1000 mg Oral

Indications

No indication recorded.