check_circleStudy Completed
Clinical Pharmacology
Bayer Identifier:
15130
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
EU CT Number:
Not Available
BAY106-7197, Midazolam interaction study
Trial purpose
The primary objective was to
• Investigate the influence of a single dose of BAY 1067197 on the pharmacokinetics of a single oral dose of midazolam in healthy male subjects
Secondary objective was to
• Assess safety and tolerability
• Investigate the influence of a single dose of BAY 1067197 on the pharmacokinetics of a single oral dose of midazolam in healthy male subjects
Secondary objective was to
• Assess safety and tolerability
Key Participants Requirements
Sex
MaleAge
18 - 45 YearsTrial summary
Enrollment Goal
12Trial Dates
March 2013 - July 2013Phase
Phase 1Could I Receive a placebo
NoProducts
Neladenoson Bialanate (BAY1067197)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Bayer Pharma AG | Berlin, 13353, Germany |
Primary Outcome
- Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) of Midazolam in PlasmaArea under the concentration versus time curve from zero to infinity after single (first) dose.date_rangeTime Frame:Pre-dose at 0.5 hour on Day 0; post-dose at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15 hours on Day 1; 0 and 12 hours on Day 2; Day 3enhanced_encryptionNoSafety Issue:
- Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) of Metabolite 1-hydroxymidazolam in PlasmaArea under the concentration versus time curve from zero to infinity after single (first) dose.date_rangeTime Frame:Pre-dose at 0.5 hour on Day 0; post-dose at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15 hours on Day 1; 0 and 12 hours on Day 2; Day 3enhanced_encryptionNoSafety Issue:
- Maximum Observed Drug Concentration in Measured Matrix (Cmax) of Midazolam in PlasmaMaximum observed drug concentration, directly taken from analytical data.date_rangeTime Frame:Pre-dose at 0.5 hour on Day 0; Post-dose at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15 hours on Day 1; 0 and 12 hours on Day 2; Day 3enhanced_encryptionNoSafety Issue:
- Maximum Observed Drug Concentration in Measured Matrix (Cmax) of Metabolite 1-hydroxymidazolam in PlasmaMaximum observed drug concentration, directly taken from analytical data.date_rangeTime Frame:Pre-dose at 0.5 hour on Day 0; Post-dose at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15 hours on Day 1; 0 and 12 hours on Day 2; Day 3enhanced_encryptionNoSafety Issue:
- Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) Ratio of Metabolite 1-hydroxymidazolam/Midazolam in Plasmadate_rangeTime Frame:Pre-dose at 0.5 hour on Day 0; Post-dose at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15 hours on Day 1; 0 and 12 hours on Day 2; Day 3enhanced_encryptionNoSafety Issue:
- Area Under the Concentration Versus Time Curve From Zero to Last Quantifiable Concentration [AUC(0-tlast)] Ratio of Metabolite 1-hydroxymidazolam/Midazolam in Plasmadate_rangeTime Frame:Pre-dose at 0.5 hour on Day 0; Post-dose at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15 hours on Day 1; 0 and 12 hours on Day 2; Day 3enhanced_encryptionNoSafety Issue:
- Area Under the Concentration Versus Time Curve From 0 to 0.5 Hour After Dosing [AUC(0-0.5)] Ratio of Metabolite 1-hydroxymidazolam/Midazolam in Plasmadate_rangeTime Frame:Pre-dose at 0.5 hour on Day 0; Post-dose at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15 hours on Day 1; 0 and 12 hours on Day 2; Day 3enhanced_encryptionNoSafety Issue:
- Area Under the Concentration Versus Time Curve From 0 to 1 Hour After Dosing [AUC(0-1)] Ratio of 1-hydroxymidazolam/Midazolam in Plasmadate_rangeTime Frame:Pre-dose at 0.5 hour on Day 0; Post-dose at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15 hours on Day 1; 0 and 12 hours on Day 2; Day 3enhanced_encryptionNoSafety Issue:
- Area Under the Concentration Versus Time Curve From 0 to 0.5 Hour After Dosing [AUC(0-0.5)] of Midazolam in Plasmadate_rangeTime Frame:Pre-dose at 0.5 hour on Day 0; Post-dose at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15 hours on Day 1; 0 and 12 hours on Day 2; Day 3enhanced_encryptionNoSafety Issue:
- Area Under the Concentration Versus Time Curve From 0 to 0.5 Hour After Dosing [AUC(0-0.5)] of Metabolite 1-hydroxymidazolam in Plasmadate_rangeTime Frame:Pre-dose at 0.5 hour on Day 0; Post-dose at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15 hours on Day 1; 0 and 12 hours on Day 2; Day 3enhanced_encryptionNoSafety Issue:
- Area Under the Concentration Versus Time Curve From 0 to 1 Hour After Dosing [AUC(0-1)] of Midazolam in Plasmadate_rangeTime Frame:Pre-dose at 0.5 hour on Day 0; Post-dose at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15 hours on Day 1; 0 and 12 hours on Day 2; Day 3enhanced_encryptionNoSafety Issue:
- Area Under the Concentration Versus Time Curve From 0 to 1 Hour After Dosing [AUC(0-1)] of Metabolite 1-hydroxymidazolam in Plasmadate_rangeTime Frame:Pre-dose at 0.5 hour on Day 0; Post-dose at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15 hours on Day 1; 0 and 12 hours on Day 2; Day 3enhanced_encryptionNoSafety Issue:
Secondary Outcome
- Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) of BAY1067197 in PlasmaArea under the concentration versus time curve from zero to infinity after single (first) dose.date_rangeTime Frame:Post-dose at 0.5 hour on Day 0; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15 hours on Day 1; 0 and 12 hours on Day 2; Day 3, 4, 6, 8, 10, 15, 19enhanced_encryptionNoSafety Issue:
- Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) of Metabolite BAY84-3174 in PlasmaArea under the concentration versus time curve from zero to infinity after single (first) dose.date_rangeTime Frame:Post-dose at 0.5 hour on Day 0; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15 hours on Day 1; 0 and 12 hours on Day 2; Day 3, 4, 6, 8, 10, 15, 19enhanced_encryptionNoSafety Issue:
- Area Under the Concentration Versus Time Curve From Zero to Last Quantifiable Concentration [AUC(0-tlast)] of Midazolam in PlasmaAUC from time 0 to the last data point >lower limit of quantification (0.200 microgram per liter), calculated up by linear trapezoidal rule, down by logarithmic trapezoidal rule.date_rangeTime Frame:Pre-dose at 0.5 hour on Day 0; Post-dose at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15 hours on Day 1; 0 and 12 hours on Day 2; Day 3enhanced_encryptionNoSafety Issue:
- Area Under the Concentration Versus Time Curve From Zero to Last Quantifiable Concentration [AUC(0-tlast)] of Metabolite 1-hydroxymidazolamAUC from time 0 to the last data point >lower limit of quantification (0.200 microgram per liter), calculated up by linear trapezoidal rule, down by logarithmic trapezoidal rule.date_rangeTime Frame:Pre-dose at 0.5 hour on Day 0; Post-dose at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15 hours on Day 1; 0 and 12 hours on Day 2; Day 3enhanced_encryptionNoSafety Issue:
- Area Under the Concentration Versus Time Curve From Zero to Last Quantifiable Concentrationv[AUC(0-tlast)]vof BAY1067197 in PlasmaAUC from time 0 to the last data point >lower limit of quantification (0.100 microgram per liter), calculated up by linear trapezoidal rule, down by logarithmic trapezoidal rule.date_rangeTime Frame:Post-dose at 0.5 hour on Day 0; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15 hours on Day 1; 0 and 12 hours on Day 2; Day 3, 4, 6, 8, 10, 15, 19enhanced_encryptionNoSafety Issue:
- Area Under the Concentration Versus Time Curve From Zero to Last Quantifiable Concentration [AUC(0-tlast)] of BAY84-3174 in PlasmaAUC from time 0 to the last data point >lower limit of quantification (0.100 microgram per liter), calculated up by linear trapezoidal rule, down by logarithmic trapezoidal rule.date_rangeTime Frame:Post-dose at 0.5 hour on Day 0; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15 hours on Day 1; 0 and 12 hours on Day 2; Day 3, 4, 6, 8, 10, 15, 19enhanced_encryptionNoSafety Issue:
- Maximum Observed Drug Concentration in Measured Matrix (Cmax) of BAY1067197 in PlasmaMaximum observed drug concentration, directly taken from analytical data.date_rangeTime Frame:Post-dose at 0.5 hour on Day 0; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15 hours on Day 1; 0 and 12 hours on Day 2; Day 3, 4, 6, 8, 10, 15, 19enhanced_encryptionNoSafety Issue:
- Maximum Observed Drug Concentration in Measured Matrix (Cmax) of Metabolite BAY84-3174 in PlasmaMaximum observed drug concentration, directly taken from analytical data.date_rangeTime Frame:Post-dose at 0.5 hour on Day 0; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15 hours on Day 1; 0 and 12 hours on Day 2; Day 3, 4, 6, 8, 10, 15, 19enhanced_encryptionNoSafety Issue:
- Time to Reach Maximum Observed Drug Concentration (tmax) of Midazolam in PlasmaTime to reach maximum drug or metabolite concentration in the measured matrix, directly taken from analytical data. In case of two identical Cmax values, the first tmax will be used.date_rangeTime Frame:Pre-dose at 0.5 hour on Day 0; Post-dose at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15 hours on Day 1; 0 and 12 hours on Day 2; Day 3enhanced_encryptionNoSafety Issue:
- Time to Reach Maximum Observed Drug Concentration (tmax) of Metabolite 1-hydroxymidazolam in PlasmaTime to reach maximum drug or metabolite concentration in the measured matrix, directly taken from analytical data. In case of two identical Cmax values, the first tmax will be used.date_rangeTime Frame:Pre-dose at 0.5 hour on Day 0; Post-dose at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15 hours on Day 1; 0 and 12 hours on Day 2; Day 3enhanced_encryptionNoSafety Issue:
- Time to Reach Maximum Observed Drug Concentration (tmax) of BAY1067197 in PlasmaTime to reach maximum drug or metabolite concentration in the measured matrix, directly taken from analytical data. In case of two identical Cmax values, the first tmax will be used.date_rangeTime Frame:Post-dose at 0.5 hour on Day 0; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15 hours on Day 1; 0 and 12 hours on Day 2; Day 3, 4, 6, 8, 10, 15, 19enhanced_encryptionNoSafety Issue:
- Time to Reach Maximum Observed Drug Concentration (tmax) of Metabolite BAY84-3174 in PlasmaTime to reach maximum drug or metabolite concentration in the measured matrix, directly taken from analytical data. In case of two identical Cmax values, the first tmax will be used.date_rangeTime Frame:Post-dose at 0.5 hour on Day 0; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15 hours on Day 1; 0 and 12 hours on Day 2; Day 3, 4, 6, 8, 10, 15, 19enhanced_encryptionNoSafety Issue:
- Terminal Elimination half-life (t1/2) of Midazolam in PlasmaHalf-life associated with the terminal slope.date_rangeTime Frame:Pre-dose at 0.5 hour on Day 0; Post-dose at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15 hours on Day 1; 0 and 12 hours on Day 2; Day 3enhanced_encryptionNoSafety Issue:
- Terminal Elimination half-life (t1/2) of Metabolite 1-hydroxymidazolam in PlasmaHalf-life associated with the terminal slope.date_rangeTime Frame:Pre-dose at 0.5 hour on Day 0; Post-dose at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15 hours on Day 1; 0 and 12 hours on Day 2; Day 3enhanced_encryptionNoSafety Issue:
- Terminal Elimination half-life (t1/2) of BAY1067197 in PlasmaHalf-life associated with the terminal slope.date_rangeTime Frame:Pre-dose at 0.5 hour on Day 0; Post-dose at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15 hours on Day 1; 0 and 12 hours on Day 2; Day 3enhanced_encryptionNoSafety Issue:
- Terminal Elimination half-life (t1/2) of BAY1067197 in PlasmaHalf-life associated with the terminal slope.date_rangeTime Frame:Post-dose at 0.5 hour on Day 0; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15 hours on Day 1; 0 and 12 hours on Day 2; Day 3, 4, 6, 8, 10, 15, 19enhanced_encryptionNoSafety Issue:
- Terminal Elimination half-life (t1/2) of Metabolite BAY84-3174 in PlasmaHalf-life associated with the terminal slope.date_rangeTime Frame:Post-dose at 0.5 hour on Day 0; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15 hours on Day 1; 0 and 12 hours on Day 2; Day 3, 4, 6, 8, 10, 15, 19enhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
Basic ScienceAllocation
Non-randomizedBlinding
Open LabelAssignment
Crossover AssignmentTrial Arms
2Additional Information
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