Phase 1
N=13
Effect of Copanlisib on Metformin Pharmacokinetics and Pharmacodynamics
Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT03655301 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: Primary: Maximum Drug Concentration of Metformin in Plasma After Single Dose Administration (Cmax) — 1550; 1460 microgram per liter (mcg/L)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Copanlisib (Aliqopa, BAY80-6946) (Drug); Metformin (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Drug Concentration of Metformin in Plasma After Single Dose Administration (Cmax) |
1550; 1460 | — |
| PRIMARY Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours of Metformin After Single Dose Administration (AUC[0-24]) |
7710; 8640 | — |
| PRIMARY Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity of Metformin After Single Dose Administration (AUC) |
8000; 8900 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events |
5; 9; 11 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events by Severity |
5; 0; 8; 7; 2; 4 | — |
| SECONDARY Plasma Lactate Levels |
0.78; 0.74; 0.83; 0.74; 1.01; 0.75 | — |
| SECONDARY Maximum Change From Baseline in Plasma Lactate Levels |
-0.04; 0.05; -0.04; 0.23; -0.03; 0.02 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03655301). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.