NCT03655301

Effect of Copanlisib on Metformin Pharmacokinetics and Pharmacodynamics

An Open-label, Non-randomized, Phase I Study to Evaluate the Effect of Copanlisib (a Single Intravenous Dose of 60 mg) on the Pharmacokinetics (PK) and Pharmacodynamics (PD) of Metformin (MATE2-K Substrate) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Copanlisib (Aliqopa, BAY80-6946)	The copanlisib dose for this study is the standard dose recently approved and also used in Phase 1, 2 and 3 studies across the copanlisib development program: 60 mg i.v. infusion administered intermittently on Days 1, 8 and 15 of a 28-day cycle. In this study subjects will receive a single i.v. dose of 60 mg copanlisib on day 8.
DRUG	Metformin	Single dose of 1000 mg is administered orally.

Timeline

• Start date: 2018-09-11
• Primary completion: 2018-11-12
• Completion: 2019-02-12
• First posted: 2018-08-31
• Last updated: 2020-01-28
• Results posted: 2019-12-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study