Study Completed

Healthy Volunteers

Bayer Identifier:

16353

ClinicalTrials.gov Identifier:

NCT02119221

EudraCT Number:

2013-002544-90

EU CT Number:

Not Available

Copanlisib Mass Balance Study

Trial purpose

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.

Key Participants Requirements

Sex

Male

Age

45 - 65 Years

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

Trial summary

Enrollment Goal

Trial Dates

February 2014 - October 2014

Phase

Phase 1

Could I Receive a placebo

Products

Aliqopa (Copanlisib, BAY80-6946)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed	Pharma Bio-Research	Zuidlaren, 9471 GP, Netherlands

Primary Outcome

Pharmacokinetics of copanlisib in plasma by maximum concentration (Cmax)
Time Frame:
Multiple time points up to 336 hours
Safety Issue:
No
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)
Time Frame:
Multiple time points up to 336 hours
Safety Issue:
No
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))
Time Frame:
Multiple time points up to 336 hours
Safety Issue:
No
Pharmacokinetics of total radioactivity in plasma by Cmax
Time Frame:
Multiple time points up to 336 hours
Safety Issue:
No
Pharmacokinetics of total radioactivity in plasma by AUC
Time Frame:
Multiple time points up to 336 hours
Safety Issue:
No
Pharmacokinetics of total radioactivity in plasma by AUC(0-tlast)
Time Frame:
Multiple time points up to 336 hours
Safety Issue:
No
Pharmacokinetics of total radioactivity in whole blood by Cmax
Time Frame:
Multiple time points up to 336 hours
Safety Issue:
No
Pharmacokinetics of total radioactivity in whole blood by AUC
Time Frame:
Multiple time points up to 336 hours
Safety Issue:
No
Pharmacokinetics of total radioactivity in whole blood by AUC(0-tlast)
Time Frame:
Multiple time points up to 336 hours
Safety Issue:
No
Radioactivity excreted in urine as a percentage of the dose (AE,ur)
Time Frame:
Multiple time points up to 336 hours
Safety Issue:
No
Radioactivity excreted in feces as a percentage of the dose (AE,fec)
Time Frame:
Multiple time points up to 336 hours
Safety Issue:
No
Metabolite profile in plasma
Time Frame:
Multiple time points up to 336 hours
Safety Issue:
No
Metabolite profile in urine
Time Frame:
Multiple time points up to 336 hours
Safety Issue:
No
Metabolite profile in feces
Time Frame:
Multiple time points up to 336 hours
Safety Issue:
No

Secondary Outcome

Number of participants with adverse events as a measure of safety and tolerability
Time Frame:
Until 30 days after study drug administration
Safety Issue:
Yes

Trial design

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

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Basic Science

Allocation

N/A

Blinding

Open Label

Assignment

Single Group Assignment

Trial Arms

Additional Information

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