Copanlisib Mass Balance Study

Study Overview
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Brief Summary
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The study aims to provide understanding of the relative relevance of the different excretion pathways of Copanlisib in humans, as well as to characterize its metabolite profile.

Official Title
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Single Center, Open-label, Non-randomized, Non-placebo-controlled Study to Investigate the Metabolism, Excretion Pattern, Mass Balance, Safety, Tolerability and Pharmacokinetics After Single Intravenous Administration of 12 mg [14C]Copanlisib (BAY 80-6946) in Healthy Male Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Copanlisib (BAY80-6946)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male subject Age: 45 to 65 years Body weight greater or equal to 60 kg and body mass index (BMI): above/equal 18 and below/equal 30 kg/m² Exclusion Criteria: Regular use of medicines Known recent (last 2 years) abuse of recreational drugs, suspicion of drug or alcohol abuse, or positive results of the drug and alcohol screen tests at screening or baseline Use of strong inhibitors of cytochrome P450 (CYP)3A4, as well as use of St John's Wort or strong inducers of CYP3A4 prohibited from 14 days before the administration of study drug until discharge from the clinic Smoking Average intake of more than 24 units of alcohol per week; Regular daily consumption of more than 1 L of methylxanthine-containing beverages Any condition, which may result in longer than usual retention of urine or feces in the body, such as pronounced (less than one defecation in 2 days) constipation or symptomatic prostatic hypertrophy. Participation in another mass balance study with a radiation burden > 0.1 mSv in the period of 1 year before screening

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [14C]Copanlisib<br> | Drug: Copanlisib (BAY80-6946)<br>* Intravenous infusion of 12 mg copanlisib labeled with 2.76 MBq (75 μCi) of [14C]<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of copanlisib in plasma by maximum concentration (Cmax) |  | Multiple time points up to 336 hours | 
| Pharmacokinetics of copanlisib in plasma by area under the measured matrix concentration versus time curve from the first time point (t=0) extrapolated to infinity (AUC) |  | Multiple time points up to 336 hours | 
| Pharmacokinetics of copanlisib in plasma by area under the measured matrix concentration versus time curve to the last data point above the lower limit of quantitation (AUC(0-tlast)) |  | Multiple time points up to 336 hours | 
| Pharmacokinetics of total radioactivity in plasma by Cmax |  | Multiple time points up to 336 hours | 
| Pharmacokinetics of total radioactivity in plasma by AUC |  | Multiple time points up to 336 hours | 
| Pharmacokinetics of total radioactivity in plasma by AUC(0-tlast) |  | Multiple time points up to 336 hours | 
| Pharmacokinetics of total radioactivity in whole blood by Cmax |  | Multiple time points up to 336 hours | 
| Pharmacokinetics of total radioactivity in whole blood by AUC |  | Multiple time points up to 336 hours | 
| Pharmacokinetics of total radioactivity in whole blood by AUC(0-tlast) |  | Multiple time points up to 336 hours | 
| Radioactivity excreted in urine as a percentage of the dose (AE,ur) |  | Multiple time points up to 336 hours | 
| Radioactivity excreted in feces as a percentage of the dose (AE,fec) |  | Multiple time points up to 336 hours | 
| Metabolite profile in plasma |  | Multiple time points up to 336 hours | 
| Metabolite profile in urine |  | Multiple time points up to 336 hours | 
| Metabolite profile in feces |  | Multiple time points up to 336 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events as a measure of safety and tolerability |  | Until 30 days after study drug administration |