Trial Condition(s):

Healthy Volunteers

Effect of Copanlisib on metformin pharmacokinetics and pharmacodynamics

Bayer Identifier:

19951

ClinicalTrials.gov Identifier:

NCT03655301

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

Inclusion Criteria
- Healthy male or female subjects – as determined by the investigator or medically qualified designee based on medical evaluations, including medical history, physical examination, laboratory tests and cardiac monitoring
- Aged 18 to 45 years at the first screening visit
- Body Mass Index (BMI) of 18.0 - 34 kg / m*2 , with body weight ≥ 50 kg
- Creatinine clearance ≥ 90 mL/min using the Modification of Diet in Renal Disease
- Adequate end organ and bone marrow function
Exclusion Criteria
- Existing relevant diseases of vital organs (e.g. liver diseases, heart diseases), central nervous system (for example seizures) or other organs (e.g. diabetes mellitus)
- Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
- Relevant respiratory insufficiency / disorder
- Administration of strong CYP3A4 inhibitors or inducers within 2 weeks prior to dosing
- Known history of hypersensitivity (or known allergic reaction) to copanlisib, metformin, related compounds, or any components of the formulation

Trial Summary

Enrollment Goal
13
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Aliqopa (Copanlisib, BAY80-6946)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Pharmaceutical Product Development (PPD), LLC

Austin, United States, 78744

Status
Completed
 

Trial Design