check_circleStudy Completed

Clinical Pharmacology

Bayer Identifier:

15130

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2012-003803-36

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

Key Participants Requirements

Sex

Male

Age

18 - 45 Years
  • 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
  • -

Trial summary

Enrollment Goal
12
Trial Dates
March 2013 - July 2013
Phase
Phase 1
Could I Receive a placebo
No
Products
Neladenoson Bialanate (BAY1067197)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Bayer Pharma AGBerlin, 13353, Germany

Primary Outcome

  • Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) of Midazolam in Plasma
    Area 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 3
    enhanced_encryption
    Safety Issue:
    No
  • Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) of Metabolite 1-hydroxymidazolam in Plasma
    Area 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 3
    enhanced_encryption
    Safety Issue:
    No
  • Maximum Observed Drug Concentration in Measured Matrix (Cmax) of Midazolam in Plasma
    Maximum 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 3
    enhanced_encryption
    Safety Issue:
    No
  • Maximum Observed Drug Concentration in Measured Matrix (Cmax) of Metabolite 1-hydroxymidazolam in Plasma
    Maximum 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 3
    enhanced_encryption
    Safety Issue:
    No
  • Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) Ratio of Metabolite 1-hydroxymidazolam/Midazolam in Plasma
    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 3
    enhanced_encryption
    Safety Issue:
    No
  • Area Under the Concentration Versus Time Curve From Zero to Last Quantifiable Concentration [AUC(0-tlast)] Ratio of Metabolite 1-hydroxymidazolam/Midazolam in Plasma
    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 3
    enhanced_encryption
    Safety Issue:
    No
  • 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 Plasma
    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 3
    enhanced_encryption
    Safety Issue:
    No
  • Area Under the Concentration Versus Time Curve From 0 to 1 Hour After Dosing [AUC(0-1)] Ratio of 1-hydroxymidazolam/Midazolam in Plasma
    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 3
    enhanced_encryption
    Safety Issue:
    No
  • Area Under the Concentration Versus Time Curve From 0 to 0.5 Hour After Dosing [AUC(0-0.5)] of Midazolam in Plasma
    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 3
    enhanced_encryption
    Safety Issue:
    No
  • Area Under the Concentration Versus Time Curve From 0 to 0.5 Hour After Dosing [AUC(0-0.5)] of Metabolite 1-hydroxymidazolam in Plasma
    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 3
    enhanced_encryption
    Safety Issue:
    No
  • Area Under the Concentration Versus Time Curve From 0 to 1 Hour After Dosing [AUC(0-1)] of Midazolam in Plasma
    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 3
    enhanced_encryption
    Safety Issue:
    No
  • Area Under the Concentration Versus Time Curve From 0 to 1 Hour After Dosing [AUC(0-1)] of Metabolite 1-hydroxymidazolam in Plasma
    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 3
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) of BAY1067197 in Plasma
    Area 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, 19
    enhanced_encryption
    Safety Issue:
    No
  • Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) of Metabolite BAY84-3174 in Plasma
    Area 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, 19
    enhanced_encryption
    Safety Issue:
    No
  • Area Under the Concentration Versus Time Curve From Zero to Last Quantifiable Concentration [AUC(0-tlast)] of Midazolam in Plasma
    AUC 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 3
    enhanced_encryption
    Safety Issue:
    No
  • Area Under the Concentration Versus Time Curve From Zero to Last Quantifiable Concentration [AUC(0-tlast)] of Metabolite 1-hydroxymidazolam
    AUC 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 3
    enhanced_encryption
    Safety Issue:
    No
  • Area Under the Concentration Versus Time Curve From Zero to Last Quantifiable Concentrationv[AUC(0-tlast)]vof BAY1067197 in Plasma
    AUC 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, 19
    enhanced_encryption
    Safety Issue:
    No
  • Area Under the Concentration Versus Time Curve From Zero to Last Quantifiable Concentration [AUC(0-tlast)] of BAY84-3174 in Plasma
    AUC 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, 19
    enhanced_encryption
    Safety Issue:
    No
  • Maximum Observed Drug Concentration in Measured Matrix (Cmax) of BAY1067197 in Plasma
    Maximum 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, 19
    enhanced_encryption
    Safety Issue:
    No
  • Maximum Observed Drug Concentration in Measured Matrix (Cmax) of Metabolite BAY84-3174 in Plasma
    Maximum 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, 19
    enhanced_encryption
    Safety Issue:
    No
  • Time to Reach Maximum Observed Drug Concentration (tmax) of Midazolam in Plasma
    Time 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 3
    enhanced_encryption
    Safety Issue:
    No
  • Time to Reach Maximum Observed Drug Concentration (tmax) of Metabolite 1-hydroxymidazolam in Plasma
    Time 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 3
    enhanced_encryption
    Safety Issue:
    No
  • Time to Reach Maximum Observed Drug Concentration (tmax) of BAY1067197 in Plasma
    Time 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, 19
    enhanced_encryption
    Safety Issue:
    No
  • Time to Reach Maximum Observed Drug Concentration (tmax) of Metabolite BAY84-3174 in Plasma
    Time 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, 19
    enhanced_encryption
    Safety Issue:
    No
  • Terminal Elimination half-life (t1/2) of Midazolam in Plasma
    Half-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 3
    enhanced_encryption
    Safety Issue:
    No
  • Terminal Elimination half-life (t1/2) of Metabolite 1-hydroxymidazolam in Plasma
    Half-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 3
    enhanced_encryption
    Safety Issue:
    No
  • Terminal Elimination half-life (t1/2) of BAY1067197 in Plasma
    Half-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 3
    enhanced_encryption
    Safety Issue:
    No
  • Terminal Elimination half-life (t1/2) of BAY1067197 in Plasma
    Half-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, 19
    enhanced_encryption
    Safety Issue:
    No
  • Terminal Elimination half-life (t1/2) of Metabolite BAY84-3174 in Plasma
    Half-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, 19
    enhanced_encryption
    Safety Issue:
    No

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

Additional Information

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