Healthy VolunteersPhase 1NCT02119221
Copanlisib Mass Balance Study
A Phase 1 study testing Copanlisib (BAY80-6946) in people with Healthy Volunteers, run by Bayer at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 45 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Copanlisib (BAY80-6946)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2014to Oct 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Copanlisib (BAY80-6946)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Copanlisib (BAY80-6946)Drug
Intravenous infusion of 12 mg copanlisib labeled with 2.76 MBq (75 μCi) of [14C]
| Study group | Role | What they receive |
|---|---|---|
| [14C]Copanlisib | Experimental | Not described Receives: Drug: Copanlisib (BAY80-6946) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of copanlisib in plasma by maximum concentration (Cmax)
Measured: 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)
Measured: 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))
Measured: Multiple time points up to 336 hours
Pharmacokinetics of total radioactivity in plasma by Cmax
Measured: Multiple time points up to 336 hours
Pharmacokinetics of total radioactivity in plasma by AUC
Measured: Multiple time points up to 336 hours
Pharmacokinetics of total radioactivity in plasma by AUC(0-tlast)
Measured: Multiple time points up to 336 hours
Pharmacokinetics of total radioactivity in whole blood by Cmax
Measured: Multiple time points up to 336 hours
Pharmacokinetics of total radioactivity in whole blood by AUC
Measured: Multiple time points up to 336 hours
Pharmacokinetics of total radioactivity in whole blood by AUC(0-tlast)
Measured: Multiple time points up to 336 hours
Radioactivity excreted in urine as a percentage of the dose (AE,ur)
Measured: Multiple time points up to 336 hours
Radioactivity excreted in feces as a percentage of the dose (AE,fec)
Measured: Multiple time points up to 336 hours
Metabolite profile in plasma
Measured: Multiple time points up to 336 hours
Metabolite profile in urine
Measured: Multiple time points up to 336 hours
Metabolite profile in feces
Measured: Multiple time points up to 336 hours
Secondary outcomes (1)
Number of participants with adverse events as a measure of safety and tolerability
Measured: Until 30 days after study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startFeb 2014
- Primary completionApr 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02119221
- Sponsor's protocol ID
- 16353
- Other IDs
- 2013-002544-90
- Status last verified
- Oct 2014
- First submitted
- 17 Apr 2014
- Last updated
- 28 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02119221
- Acronym / sponsor ID
- 16353
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 21 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]Copanlisib | Experimental | Drug: Copanlisib (BAY80-6946) |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Copanlisib (BAY80-6946)Intravenous infusion of 12 mg copanlisib labeled with 2.76 MBq (75 μCi) of [14C] | Drug | [14C]Copanlisib |
Primary outcome
Pharmacokinetics of copanlisib in plasma by maximum concentration (Cmax)
Time frame: 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)
Time frame: 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))
Time frame: Multiple time points up to 336 hours
Pharmacokinetics of total radioactivity in plasma by Cmax
Time frame: Multiple time points up to 336 hours
Pharmacokinetics of total radioactivity in plasma by AUC
Time frame: Multiple time points up to 336 hours
Pharmacokinetics of total radioactivity in plasma by AUC(0-tlast)
Time frame: Multiple time points up to 336 hours
Pharmacokinetics of total radioactivity in whole blood by Cmax
Time frame: Multiple time points up to 336 hours
Pharmacokinetics of total radioactivity in whole blood by AUC
Time frame: Multiple time points up to 336 hours
Pharmacokinetics of total radioactivity in whole blood by AUC(0-tlast)
Time frame: Multiple time points up to 336 hours
Radioactivity excreted in urine as a percentage of the dose (AE,ur)
Time frame: Multiple time points up to 336 hours
Radioactivity excreted in feces as a percentage of the dose (AE,fec)
Time frame: Multiple time points up to 336 hours
Metabolite profile in plasma
Time frame: Multiple time points up to 336 hours
Metabolite profile in urine
Time frame: Multiple time points up to 336 hours
Metabolite profile in feces
Time frame: Multiple time points up to 336 hours
1 secondary outcome
Number of participants with adverse events as a measure of safety and tolerability
Time frame: Until 30 days after study drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Copanlisib (BAY80-6946) in people with Healthy Volunteers, run by Bayer at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics of copanlisib in plasma by maximum concentration (Cmax) (time frame: Multiple time points up to 336 hours). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2014.