Copanlisib Mass Balance Study

NCT ID: NCT02119221

Last Updated: 2014-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2014-10-31

Brief 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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

[14C]Copanlisib

Group Type: EXPERIMENTAL

Copanlisib (BAY80-6946)

Intervention Type: DRUG

Intravenous infusion of 12 mg copanlisib labeled with 2.76 MBq (75 μCi) of \[14C\]

Interventions

Copanlisib (BAY80-6946)

Intravenous infusion of 12 mg copanlisib labeled with 2.76 MBq (75 μCi) of \[14C\]

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Zuidlaren, , Netherlands

Countries

Netherlands

Other Identifiers

2013-002544-90

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

16353

Identifier Type: -

Identifier Source: org_study_id