Trial Condition(s):
Clinical Pharmacology
BAY106-7197, Midazolam interaction study
Bayer Identifier:
15130
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
EU CT Number:
Not Available
Study Completed
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
Inclusion Criteria
Healthy young male subjects, 18 to 45 years of age, with body mass index between 18.0 and 29.9 kg/m2 inclusive were enrolled
Exclusion Criteria
No Exclusion Criteria Available
Trial Summary
Enrollment Goal
12
Trial Dates
Phase
1
Could I receive a placebo?
No
Products
Neladenoson Bialanate (BAY1067197)
Accepts Healthy Volunteers
Yes
Where to Participate
Loading...
Locations
| Locations | |
|---|---|
Locations Bayer Pharma AG Berlin, Germany, 13353 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Open-label, one-way crossover study to investigate the influence of a single dose of BAY 1067197 on pharmacokinetics, safety, and tolerability of a single oral dose of midazolam in healthy male subjects
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Basic Science
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Crossover Assignment
Trial Arms:
2
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.Timeframe: 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 3
- 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.Timeframe: 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 3
- Maximum Observed Drug Concentration in Measured Matrix (Cmax) of Midazolam in PlasmaMaximum observed drug concentration, directly taken from analytical data.Timeframe: 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 3
- Maximum Observed Drug Concentration in Measured Matrix (Cmax) of Metabolite 1-hydroxymidazolam in PlasmaMaximum observed drug concentration, directly taken from analytical data.Timeframe: 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 3
- Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) Ratio of Metabolite 1-hydroxymidazolam/Midazolam in PlasmaTimeframe: 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 3
- Area Under the Concentration Versus Time Curve From Zero to Last Quantifiable Concentration [AUC(0-tlast)] Ratio of Metabolite 1-hydroxymidazolam/Midazolam in PlasmaTimeframe: 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 3
- 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 PlasmaTimeframe: 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 3
- Area Under the Concentration Versus Time Curve From 0 to 1 Hour After Dosing [AUC(0-1)] Ratio of 1-hydroxymidazolam/Midazolam in PlasmaTimeframe: 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 3
- Area Under the Concentration Versus Time Curve From 0 to 0.5 Hour After Dosing [AUC(0-0.5)] of Midazolam in PlasmaTimeframe: 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 3
- Area Under the Concentration Versus Time Curve From 0 to 0.5 Hour After Dosing [AUC(0-0.5)] of Metabolite 1-hydroxymidazolam in PlasmaTimeframe: 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 3
- Area Under the Concentration Versus Time Curve From 0 to 1 Hour After Dosing [AUC(0-1)] of Midazolam in PlasmaTimeframe: 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 3
- Area Under the Concentration Versus Time Curve From 0 to 1 Hour After Dosing [AUC(0-1)] of Metabolite 1-hydroxymidazolam in PlasmaTimeframe: 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 3
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.Timeframe: 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, 19
- 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.Timeframe: 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, 19
- 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.Timeframe: 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 3
- 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.Timeframe: 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 3
- 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.Timeframe: 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, 19
- 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.Timeframe: 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, 19
- Maximum Observed Drug Concentration in Measured Matrix (Cmax) of BAY1067197 in PlasmaMaximum observed drug concentration, directly taken from analytical data.Timeframe: 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, 19
- Maximum Observed Drug Concentration in Measured Matrix (Cmax) of Metabolite BAY84-3174 in PlasmaMaximum observed drug concentration, directly taken from analytical data.Timeframe: 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, 19
- 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.Timeframe: 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 3
- 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.Timeframe: 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 3
- 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.Timeframe: 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, 19
- 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.Timeframe: 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, 19
- Terminal Elimination half-life (t1/2) of Midazolam in PlasmaHalf-life associated with the terminal slope.Timeframe: 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 3
- Terminal Elimination half-life (t1/2) of Metabolite 1-hydroxymidazolam in PlasmaHalf-life associated with the terminal slope.Timeframe: 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 3
- Terminal Elimination half-life (t1/2) of BAY1067197 in PlasmaHalf-life associated with the terminal slope.Timeframe: 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 3
- Terminal Elimination half-life (t1/2) of BAY1067197 in PlasmaHalf-life associated with the terminal slope.Timeframe: 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, 19
- Terminal Elimination half-life (t1/2) of Metabolite BAY84-3174 in PlasmaHalf-life associated with the terminal slope.Timeframe: 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, 19
Additional Information
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