Effect of Copanlisib on Metformin Pharmacokinetics and Pharmacodynamics

PHASE1CompletedINTERVENTIONAL
Enrollment

13

Participants

Timeline

Start Date

September 11, 2018

Primary Completion Date

November 12, 2018

Study Completion Date

February 12, 2019

Conditions
Healthy Volunteers
Interventions
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.

Trial Locations (1)

78744

Pharmaceutical Product Development (PPD), LLC, Austin

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY