Effect of Copanlisib on Metformin PK and PD
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 2/27/2019 |
| Start Date: | September 11, 2018 |
| End Date: | February 12, 2019 |
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
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.
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
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