check_circleStudy Completed
Healthy Volunteers
Bayer Identifier:
19951
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Effect of Copanlisib on metformin pharmacokinetics and pharmacodynamics
Trial purpose
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.
Key Participants Requirements
Sex
AllAge
18 - 45 YearsTrial summary
Enrollment Goal
13Trial Dates
September 2018 - February 2019Phase
Phase 1Could I Receive a placebo
NoProducts
Aliqopa (Copanlisib, BAY80-6946)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Pharmaceutical Product Development (PPD), LLC | Austin, 78744, United States |
Primary Outcome
- 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.date_rangeTime Frame:Pre-dose and up to 24 hours after drug administration on Day 1 and Day 8enhanced_encryptionNoSafety Issue:
- 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.date_rangeTime Frame:Pre-dose and up to 24 hours after drug administration on Day 1 and Day 8enhanced_encryptionNoSafety Issue:
- 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.date_rangeTime Frame:Pre-dose and extrapolated up to infinity after drug administration on Day 1 and Day 8enhanced_encryptionNoSafety Issue:
Secondary Outcome
- Number of Participants with Treatment-Emergent Adverse EventsAn 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.date_rangeTime Frame:From start of study medication until 30 days after end of treatment with study medication.enhanced_encryptionYesSafety Issue:
- Number of Participants with Treatment-Emergent Adverse Events by severityAn 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.date_rangeTime Frame:From start of study medication until 30 days after end of treatment with study medication.enhanced_encryptionYesSafety Issue:
- Plasma Lactate LevelsLactate 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).date_rangeTime Frame:At Day 1 and Day 8enhanced_encryptionNoSafety Issue:
- Maximum Change from Baseline in Plasma Lactate LevelsLactate 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.date_rangeTime Frame:From pre-dose up to 24 hours after study drug administration on Day 1 and Day 8enhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
N/AAssignment
Single Group AssignmentTrial Arms
1