check_circleStudy Completed

Clinical pharmacology

Bayer Identifier:

15836

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

EU CT Number:

Not Available
Single and multiple dose escalation study in Japanese subjects

Trial purpose

The primary objective of this study is to
• Investigate the safety and tolerability of BAY1021189 after single and multiple doses of 1.25, 5, 7.5 and 10 mg in Japanese healthy male subjects

The secondary objectives are to
• Investigate the pharmacodynamics and pharmacokinetics of BAY1021189 in Japanese healthy adult male subjects
• Exploratorily investigate the influence of food intake on the pharmacokinetics of BAY1021189 in Japanese healthy adult male subjects

Key Participants Requirements

Sex

Male

Age

20 - 40 Years
  • - Japanese healthy male subjects
    - 20 to 40 years of age
    - 17.6 to 26.4 kg / m² of Body mass index (BMI)
  • - Subjects with conspicuous findings in medical history, and screening or Day 1 before
    the first study drug administration examination results
    - Subjects with diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
    - Subjects with known hypersensitivity to the study drugs (active substances, or excipients of the preparations)
    - Subjects with a history of severe allergies, non-allergic drug reactions, or multiple drug allergies
    - Subjects with lactose intolerance
    - Subjects with relevant diseases within the last 4 weeks prior to the first study drug administration
    - Subjects with febrile illness within 1 week before the first study drug administration
    - Subjects with regular use of medicines
    - Subjects with regular use of therapeutic or recreational drugs

Trial summary

Enrollment Goal
48
Trial Dates
November 2012 - May 2013
Phase
Phase 1
Could I Receive a placebo
Yes
Products
Verquvo (Vericiguat, BAY1021189)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Kagoshima, 890-0081, Japan

Primary Outcome

  • Number of participants with treatment-emergent adverse events (TEAEs)
    date_rangeTime Frame:
    Up to Day 15
  • Vital signs
    date_rangeTime Frame:
    Up to Day 11
  • 12-lead electrocardiogram (ECG)
    date_rangeTime Frame:
    Up to Day 11
  • Standing blood pressure procedure
    date_rangeTime Frame:
    Up to Day 11
  • Clinical laboratory test
    date_rangeTime Frame:
    Up to Day 15
  • AUC
    Area under the plasma concentration vs time curve from zero to infinity after single (first) dose
    date_rangeTime Frame:
    Day 1 to Day 5
  • AUC/D
    AUC divided by dose (mg)
    date_rangeTime Frame:
    Day 1 to Day 5
  • AUCnorm
    Area under the curve divided by dose per kg body weight
    date_rangeTime Frame:
    Day 1 to Day 5
  • AUC(0-24)
    AUC from time 0 to 24 hours after administration
    date_rangeTime Frame:
    Day 1 to Day 5
  • AUC(0-24)/D
    AUC(0-24) by dose (mg)
    date_rangeTime Frame:
    Day 1 to Day 5
  • AUC(0-24),norm
    AUC(0-24) divided by dose (mg) per kg body weight
    date_rangeTime Frame:
    Day 1 to Day 5
  • Cmax
    Maximum drug concentration in plasma after single dose administration
    date_rangeTime Frame:
    Day 1 to Day 5
  • Cmax/D
    Maximum drug concentration in plasma after single dose administration divided by dose (mg)
    date_rangeTime Frame:
    Day 1 to Day 5
  • Cmax,norm
    Maximum drug concentration in plasma after single dose administration divided by dose (mg) per kg body weight
    date_rangeTime Frame:
    Day 1 to Day 5
  • AUC(0-24)
    AUC from time 0 to 24 hours after administration
    date_rangeTime Frame:
    Day 5 to Day 6
  • AUC(0-24)/D
    AUC(0-24) by dose (mg)
    date_rangeTime Frame:
    Day 5 to Day 6
  • AUC(0-24),norm
    AUC(0-24) divided by dose (mg) per kg body weight
    date_rangeTime Frame:
    Day 5 to Day 6
  • Cmax
    Maximum drug concentration in plasma after single dose administration
    date_rangeTime Frame:
    Day 5 to Day 6
  • Cmax/D
    Maximum drug concentration in plasma after single dose administration divided by dose (mg)
    date_rangeTime Frame:
    Day 5 to Day 6
  • Cmax,norm
    Maximum drug concentration in plasma after single dose administration divided by dose (mg) per kg body weight
    date_rangeTime Frame:
    Day 5 to Day 6
  • tmax
    Time to reach maximum drug concentration in plasma after single (first) dose
    date_rangeTime Frame:
    Day 5 to Day 6
  • AUCτ,ss
    AUC during any dosing interval at steady state
    date_rangeTime Frame:
    Day 11 to Day 15
  • AUCτ,ss/D
    AUCτ,ss divided by dose (mg)
    date_rangeTime Frame:
    Day 11 to Day 15
  • AUCτ,ss, norm
    AUCτ,ss divided by dose (mg) per kg body weight
    date_rangeTime Frame:
    Day 11 to Day 15
  • Cmax,ss
    Maximum drug concentration in plasma at steady state during a dosage interval
    date_rangeTime Frame:
    Day 11 to Day 15
  • Cmax,ss/D
    Maximum drug concentration in plasma at steady state divided by dose (mg)
    date_rangeTime Frame:
    Day 11 to Day 15
  • Cmax,ss,norm
    Maximum drug concentration in plasma at steady state during a dosage interval divided by dose (mg) per kg body weight
    date_rangeTime Frame:
    Day 11 to Day 15

Secondary Outcome

  • AUC(0-tlast)
    AUC from time 0 to the last data point
    date_rangeTime Frame:
    Day 1 to Day 5
  • AUC(0-tlast)/D)
    AUC(0-tlast) by dose (mg)
    date_rangeTime Frame:
    Day 1 to Day 5
  • AUC(0 tlast),norm
    AUC(0-tlast) divided by dose (mg) per kg body weight
    date_rangeTime Frame:
    Day 1 to Day 5
  • tmax
    Time to reach maximum drug concentration in plasma after single (first) dose
    date_rangeTime Frame:
    Day 1 to Day 5
  • t1/2
    Half-life associated with the terminal slope
    date_rangeTime Frame:
    Day 1 to Day 5
  • MRT
    Mean residence time
    date_rangeTime Frame:
    Day 1 to Day 5
  • CL/F
    Total body clearance of drug from plasma calculated after oral administration (apparent oral clearance)
    date_rangeTime Frame:
    Day 1 to Day 5
  • AE,ur
    Amount of drug excreted via urine
    date_rangeTime Frame:
    Day 1 to Day 5
  • AE,ur(0-24)
    Amount of drug excreted into urine from 0 to 24 hours after administration
    date_rangeTime Frame:
    Day 1 to Day 5
  • %AE,ur
    Rate of amount of drug excreted into urine to the administered dose
    date_rangeTime Frame:
    Day 1 to Day 5
  • %AE,ur(0-24)
    Rate of amount of drug excreted into urine from 0 to 24 hours after
    date_rangeTime Frame:
    Day 1 to Day 5
  • CLR
    Renal body clearance of drug
    date_rangeTime Frame:
    Day 1 to Day 5
  • Vz/F
    Apparent volume of distribution during terminal phase after oral administration
    date_rangeTime Frame:
    Day 1 to Day 5
  • tmax
    Time to reach maximum drug concentration in plasma after single (first) dose
    date_rangeTime Frame:
    Day 11 to Day 15
  • t1/2
    Half-life associated with the terminal slope
    date_rangeTime Frame:
    Day 11 to Day 15
  • MRT
    Mean residence time
    date_rangeTime Frame:
    Day 11 to Day 15
  • CLss/F
    CL/F after steady state
    date_rangeTime Frame:
    Day 11 to Day 15
  • PTF
    Peak trough fluctuation
    date_rangeTime Frame:
    Day 11 to Day 15
  • AE,ur(0-24)
    Amount of drug excreted into urine from 0 to 24 hours after administration
    date_rangeTime Frame:
    Day 11 to Day 15
  • %AE,ur(0-24)
    Rate of amount of drug excreted into urine from 0 to 24 hours after administration to the administered dose
    date_rangeTime Frame:
    Day 11 to Day 15
  • CLR
    Renal body clearance of drug
    date_rangeTime Frame:
    Day 11 to Day 15
  • Accumulation ratios: RACmax, RLIN and RAAUC
    date_rangeTime Frame:
    Day 11 to Day 15

Trial design

Single-center, randomized, single-blinded, placebo-controlled, group-comparison, combined single and multiple dose escalation study to investigate safety, tolerability, pharmacodynamics and pharmacokinetics of BAY 1021189 in Japanese healthy adult male subjects
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Basic Science
Allocation
Randomized
Blinding
N/A
Assignment
N/A
Trial Arms
5