NCT02119221

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1 healthy-volunteers

Timeline
Completed

Started Feb 2014

Typical duration for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 21, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

October 28, 2014

Status Verified

October 1, 2014

Enrollment Period

2 months

First QC Date

April 17, 2014

Last Update Submit

October 27, 2014

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (14)

  • 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 Outcomes (1)

  • Number of participants with adverse events as a measure of safety and tolerability

    Until 30 days after study drug administration

Study Arms (1)

[14C]Copanlisib

EXPERIMENTAL
Drug: Copanlisib (BAY80-6946)

Interventions

Copanlisib (BAY80-6946)DRUG

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

[14C]Copanlisib

Eligibility Criteria

Age45 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Zuidlaren, 9471 GP, Netherlands

Location

MeSH Terms

Interventions

copanlisib

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2014

First Posted

April 21, 2014

Study Start

February 1, 2014

Primary Completion

April 1, 2014

Study Completion

October 1, 2014

Last Updated

October 28, 2014

Record last verified: 2014-10

Locations

NL(1)