Healthy VolunteersPhase 1NCT03655301
Effect of Copanlisib on Metformin Pharmacokinetics and Pharmacodynamics
A Phase 1 study testing Copanlisib (Aliqopa, BAY80-6946) and Metformin in people with Healthy Volunteers, run by Bayer at 1 site in United States.
Trial summary
The purpose of this study is to learn about a drug-drug interaction. When two medications are taken together at the same time, one medication may change the activity of the other medication in the body - this is called a drug-drug interaction. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Copanlisib (Aliqopa, BAY80-6946) and Metformin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2018to 12 Feb 2019
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female subjects - as determined by the investigator or medically qualified designee based on medical evaluations, including medical history, physical examination, laboratory tests and cardiac monitoring
- Aged 18 to 45 years at the first screening visit
- Body Mass Index (BMI) of 18.0 - 34 kg / m*2 , with body weight ≥ 50 kg
- Creatinine clearance ≥ 90 mL/min using the Modification of Diet in Renal Disease
- Adequate end organ and bone marrow function
Who cannot join
- Existing relevant diseases of vital organs (e.g. liver diseases, heart diseases), central nervous system (for example seizures) or other organs (e.g. diabetes mellitus)
- Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
- Relevant respiratory insufficiency / disorder
- Administration of strong CYP3A4 inhibitors or inducers within 2 weeks prior to dosing
- Known history of hypersensitivity (or known allergic reaction) to copanlisib, metformin, related compounds, or any components of the formulation
Trial locations and contacts
1 site in 1 country.
United States1 site
Pharmaceutical Product Development (PPD), LLC
Austin, Texas, 78744
About this study
Official title: An Open-label, Non-randomized, Phase I Study to Evaluate the Effect of Copanlisib (a Single Intravenous Dose of 60 mg) on the Pharmacokinetics (PK) and Pharmacodynamics (PD) of Metformin (MATE2-K Substrate) in Healthy Volunteers
The purpose of this study is to learn about a drug-drug interaction. When two medications are taken together at the same time, one medication may change the activity of the other medication in the body - this is called a drug-drug interaction. This study is looking at the effect the Bayer study drug, copanlisib, has on metformin, a commonly used medication to treat diabetes. During the study, blood and urine samples will be collected and analyzed to learn about pharmacokinetics (how copanlisib changes metformin levels in the body) and pharmacodynamics (the effect metformin has on the body when taken together with copanlisib) when someone takes both copanlisib and metformin together.
- Conditions
- Healthy Volunteers
- Being tested
- Copanlisib (Aliqopa, BAY80-6946), Metformin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Copanlisib (Aliqopa, BAY80-6946)Drug
The copanlisib dose for this study is the standard dose recently approved and also used in Phase 1, 2 and 3 studies across the copanlisib development program: 60 mg i.v. infusion administered intermittently on Days 1, 8 and 15 of a 28-day cycle.
In this study subjects will receive a single i.v. dose of 60 mg copanlisib on day 8.
MetforminDrug
Single dose of 1000 mg is administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Copanlisib (Aliqopa, BAY80-6946) | Experimental | All subjects will receive a single dose of metformin 1000 mg on Days 1 and 8 in a fasting state. Subjects will also receive a single i.v. dose of 60 mg copanlisib on Day 8 as part of the combination with metformin. Receives: Drug: Copanlisib (Aliqopa, BAY80-6946); Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Drug Concentration of Metformin in Plasma After Single Dose Administration (Cmax)
Maximum observed drug concentration of metformin in plasma after single dose administration without copanlisib (Day 1) and in combination with copanlisib (Day 8) were measured.
Measured: Pre-dose and up to 24 hours after drug administration on Day 1 and Day 8
Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours of Metformin After Single Dose Administration (AUC[0-24])
Area under the concentration versus time curve from zero to 24 hours of metformin after single dose administration without copanlisib (Day 1) and in combination with copanlisib (Day 8) were measured.
Measured: Pre-dose and up to 24 hours after drug administration on Day 1 and Day 8
Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity of Metformin After Single Dose Administration (AUC)
Area under the concentration verus time curve from zero to infinity of metformin after single dose without copanlisib (Day 1) and in combination with copanlisib (Day 8) were measured.
Measured: Pre-dose and extrapolated up to infinity after drug administration on Day 1 and Day 8
Secondary outcomes (4)
Number of Participants With Treatment-Emergent Adverse Events
An adverse event (AE) was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened after the start of study drug administration up to 30 days after last administration of the study medication.
Measured: From start of study medication until 30 days after end of treatment with study medication.
Number of Participants With Treatment-Emergent Adverse Events by Severity
An adverse event (AE) was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened after the start of study drug administration up to 30 days after last administration of the study medication. TEAEs per severity were reported.
Measured: From start of study medication until 30 days after end of treatment with study medication.
Plasma Lactate Levels
Lactate levels were analyzed in plasma samples collected during metformin alone or in combination with copanlisib. Plasma lactate levels were summarized by treatment conditions (Day 1 and Day 8).
Measured: Up to 24 hours after study drug administration on Day 1 and Day 8
Maximum Change From Baseline in Plasma Lactate Levels
Lactate levels were analyzed in plasma samples collected during metformin alone or in combination with copanlisib. Maximum change from baseline on Day 1 and Day 8 was summarized.
Measured: From pre-dose up to 24 hours after study drug administration on Day 1 and Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start11 Sep 2018
- Primary completion12 Nov 2018
- Study completion12 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03655301
- Sponsor's protocol ID
- 19951
- Status last verified
- Jan 2020
- First submitted
- 30 Aug 2018
- Last updated
- 28 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Non-randomized, Phase I Study to Evaluate the Effect of Copanlisib (a Single Intravenous Dose of 60 mg) on the Pharmacokinetics (PK) and Pharmacodynamics (PD) of Metformin (MATE2-K Substrate) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03655301
- Acronym / sponsor ID
- 19951
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 11 Sep 2018 (actual)
- Primary completion
- 12 Nov 2018 (actual)
- Study completion
- 12 Feb 2019 (actual)
- First posted
- 31 Aug 2018 (actual)
- Results
- Posted 23 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn about a drug-drug interaction. When two medications are taken together at the same time, one medication may change the activity of the other medication in the body - this is called a drug-drug interaction. This study is looking at the effect the Bayer study drug, copanlisib, has on metformin, a commonly used medication to treat diabetes. During the study, blood and urine samples will be collected and analyzed to learn about pharmacokinetics (how copanlisib changes metformin levels in the body) and pharmacodynamics (the effect metformin has on the body when taken together with copanlisib) when someone takes both copanlisib and metformin together.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Copanlisib (Aliqopa, BAY80-6946) | Experimental | Drug: Copanlisib (Aliqopa, BAY80-6946), Drug: MetforminAll subjects will receive a single dose of metformin 1000 mg on Days 1 and 8 in a fasting state. Subjects will also receive a single i.v. dose of 60 mg copanlisib on Day 8 as part of the combination with metformin. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male or female subjects - as determined by the investigator or medically qualified designee based on medical evaluations, including medical history, physical examination, laboratory tests and cardiac monitoring
- Aged 18 to 45 years at the first screening visit
- Body Mass Index (BMI) of 18.0 - 34 kg / m*2 , with body weight ≥ 50 kg
- Creatinine clearance ≥ 90 mL/min using the Modification of Diet in Renal Disease
- Adequate end organ and bone marrow function
Key exclusion criteria (5 listed)
- Existing relevant diseases of vital organs (e.g. liver diseases, heart diseases), central nervous system (for example seizures) or other organs (e.g. diabetes mellitus)
- Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
- Relevant respiratory insufficiency / disorder
- Administration of strong CYP3A4 inhibitors or inducers within 2 weeks prior to dosing
- Known history of hypersensitivity (or known allergic reaction) to copanlisib, metformin, related compounds, or any components of the formulation
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 (Aliqopa, BAY80-6946)The copanlisib dose for this study is the standard dose recently approved and also used in Phase 1, 2 and 3 studies across the copanlisib development program: 60 mg i.v. infusion administered intermittently on Days 1, 8 and 15 of a 28-day cycle. In this study subjects will receive a single i.v. dose of 60 mg copanlisib on day 8. | Drug | Copanlisib (Aliqopa, BAY80-6946) |
| MetforminSingle dose of 1000 mg is administered orally. | Drug | Copanlisib (Aliqopa, BAY80-6946) |
Primary outcome
Maximum Drug Concentration of Metformin in Plasma After Single Dose Administration (Cmax)
Time frame: Pre-dose and up to 24 hours after drug administration on Day 1 and Day 8
Maximum observed drug concentration of metformin in plasma after single dose administration without copanlisib (Day 1) and in combination with copanlisib (Day 8) were measured.
Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours of Metformin After Single Dose Administration (AUC[0-24])
Time frame: Pre-dose and up to 24 hours after drug administration on Day 1 and Day 8
Area under the concentration versus time curve from zero to 24 hours of metformin after single dose administration without copanlisib (Day 1) and in combination with copanlisib (Day 8) were measured.
Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity of Metformin After Single Dose Administration (AUC)
Time frame: Pre-dose and extrapolated up to infinity after drug administration on Day 1 and Day 8
Area under the concentration verus time curve from zero to infinity of metformin after single dose without copanlisib (Day 1) and in combination with copanlisib (Day 8) were measured.
4 secondary outcomes
Number of Participants With Treatment-Emergent Adverse Events
Time frame: From start of study medication until 30 days after end of treatment with study medication.
Number of Participants With Treatment-Emergent Adverse Events by Severity
Time frame: From start of study medication until 30 days after end of treatment with study medication.
Plasma Lactate Levels
Time frame: Up to 24 hours after study drug administration on Day 1 and Day 8
Maximum Change From Baseline in Plasma Lactate Levels
Time frame: From pre-dose up to 24 hours after study drug administration on Day 1 and Day 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 (Aliqopa, BAY80-6946) and Metformin in people with Healthy Volunteers, run by Bayer at 1 site in United States.
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 5 inclusion and 5 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 Jan 2020. 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 United States. 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?
Yes. Results are posted in the registry (first posted 23 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Maximum Drug Concentration of Metformin in Plasma After Single Dose Administration (Cmax) (time frame: Pre-dose and up to 24 hours after drug administration on Day 1 and Day 8). The study lists 3 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 Jan 2020.