Copanlisib Mass Balance Study

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02119221
• Other study ID #: 16353
• Secondary ID: 2013-002544-90
• Status: Completed
• Phase: Phase 1
• First received: April 17, 2014
• Last updated: October 27, 2014
• Start date: February 2014
• Est. completion date: October 2014

Study information

• Verified date: October 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: October 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 45 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Copanlisib (BAY80-6946)
Intravenous infusion of 12 mg copanlisib labeled with 2.76 MBq (75 µCi) of [14C]

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics of copanlisib in plasma by maximum concentration (Cmax)		Multiple time points up to 336 hours	No
Primary	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	No
Primary	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	No
Primary	Pharmacokinetics of total radioactivity in plasma by Cmax		Multiple time points up to 336 hours	No
Primary	Pharmacokinetics of total radioactivity in plasma by AUC		Multiple time points up to 336 hours	No
Primary	Pharmacokinetics of total radioactivity in plasma by AUC(0-tlast)		Multiple time points up to 336 hours	No
Primary	Pharmacokinetics of total radioactivity in whole blood by Cmax		Multiple time points up to 336 hours	No
Primary	Pharmacokinetics of total radioactivity in whole blood by AUC		Multiple time points up to 336 hours	No
Primary	Pharmacokinetics of total radioactivity in whole blood by AUC(0-tlast)		Multiple time points up to 336 hours	No
Primary	Radioactivity excreted in urine as a percentage of the dose (AE,ur)		Multiple time points up to 336 hours	No
Primary	Radioactivity excreted in feces as a percentage of the dose (AE,fec)		Multiple time points up to 336 hours	No
Primary	Metabolite profile in plasma		Multiple time points up to 336 hours	No
Primary	Metabolite profile in urine		Multiple time points up to 336 hours	No
Primary	Metabolite profile in feces		Multiple time points up to 336 hours	No
Secondary	Number of participants with adverse events as a measure of safety and tolerability		Until 30 days after study drug administration	Yes

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