check_circleStudy Completed

Clinical pharmacology

Bayer Identifier:

15837

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

EU CT Number:

Not Available
Single dose escalation Phase I study in Asians

Trial purpose

The primary objective of this study was to investigate the safety and tolerability of BAY 1021189 after single oral doses of 1.25 mg, 5 mg and 10 mg administered as one or multiples of 1.25 mg immediate-release(IR) tablet(s) in Asian (Chinese) healthy male subjects.

The secondary objectives of this study are to investigate
pharmacokinetics and pharmacodynamics of BAY1021189 in Asian (Chinese) healthy male subjects.

Key Participants Requirements

Sex

Male

Age

21 - 45
  • - Healthy male subject
    - Age: 21 to 45 years (inclusive) at the first screening examination / visit
    - Chinese healthy male subject
    - Body weight ≥50 kg, Body Mass Index (BMI) was between 19 and 27 kg/m² (inclusive)

  • - Incompletely cured pre-existing diseases for which it could be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs were not normal
    - Known hypersensitivity to the study drugs (active substances or excipients of the preparations) or to the study drugs, the control agent and / or to inactive constituents
    - Known severe allergies, non-allergic drug reactions, or multiple drug allergies
    - Relevant diseases within the last 4 weeks prior to the first study drug administration
    - Febrile illness within 1 week before the first study drug administration
    - Regular use of medicines
    - Regular use of therapeutic or recreational drugs
    - Use of systemic or topical medicines or substances which could oppose the study objectives or which could influence them within 4 weeks before the first study drug administration
    - Smoking more than 20 cigarettes daily
    - Regular daily consumption of more than 800 mL of usual beer or the equivalent quantity of approximately 32 g of alcohol in another form

Trial summary

Enrollment Goal
36
Trial Dates
July 2012 - December 2012
Phase
Phase 1
Could I Receive a placebo
Yes
Products
Verquvo (Vericiguat, BAY1021189)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Singapore, 529889, Singapore

Primary Outcome

  • Number of participants with Adverse events (AEs)
    date_rangeTime Frame:
    Up to 14 days
  • Incidence of abnormal vital parameters (blood pressure and heart rate)
    date_rangeTime Frame:
    Up to 14 days
  • Incidence of abnormal Electrocardiogram (ECG) findingsfindings
    date_rangeTime Frame:
    Up to 14 days
  • Incidence of abnormal laboratory findings
    date_rangeTime Frame:
    Up to 14 days
  • AUC
    Area under the plasma concentration vs. time curve from zero to infinity after single (first) dose
    date_rangeTime Frame:
    Pre-dose and up to 96 hours after drug administration
  • AUC/D
    AUC divided by dose (mg)
    date_rangeTime Frame:
    Pre-dose and up to 96 hours after drug administration
  • Cmax
    Maximum drug concentration in plasma after single dose administration
    date_rangeTime Frame:
    Pre-dose and up to 96 hours after drug administration
  • Cmax/D
    Maximum drug concentration in plasma after single dose administration divided by dose (mg)
    date_rangeTime Frame:
    Pre-dose and up to 96 hours after drug administration
  • Heart rate over 1 min
    date_rangeTime Frame:
    From baseline up to 4 hours after drug administration

Secondary Outcome

  • Cmax,norm
    Maximum drug concentration in plasma after single dose administration divided by dose (mg) per kg body weight
    date_rangeTime Frame:
    Pre-dose and up to 96 hours after drug administration
  • Cmax/C24
    Cmax divided by concentration at 24 h after administration
    date_rangeTime Frame:
    Pre-dose and up to 96 hours after drug administration
  • tmax
    Time to reach maximum drug concentration in plasma after single (first) dose
    date_rangeTime Frame:
    Pre-dose and up to 96 hours after drug administration
  • t½
    Half-life associated with the terminal slope
    date_rangeTime Frame:
    Pre-dose and up to 96 hours after drug administration
  • MRT
    Mean residence time
    date_rangeTime Frame:
    Pre-dose and up to 96 hours after drug administration
  • CL/f
    Total body clearance of drug from plasma calculated after oral administration (apparent oral clearance)
    date_rangeTime Frame:
    Pre-dose and up to 96 hours after drug administration
  • AUCnorm
    AUC divided by dose per kg body weight
    date_rangeTime Frame:
    Pre-dose and up to 96 hours after drug administration
  • AUC(0-tlast)
    AUC from time 0 to the last data point
    date_rangeTime Frame:
    Pre-dose and up to 96 hours after drug administration
  • AUC(0-tlast)norm
    AUC(0-tlast) divided by dose per kg body weight
    date_rangeTime Frame:
    Pre-dose and up to 96 hours after drug administration
  • Vz/f
    Apparent volume of distribution during terminal phase after oral administration
    date_rangeTime Frame:
    Pre-dose and up to 96 hours after drug administration
  • Aeur
    Amount of drug excreted via urine
    date_rangeTime Frame:
    Pre-dose and up to 96 hours after drug administration
  • CLR
    Renal clearance
    date_rangeTime Frame:
    Pre-dose and up to 96 hours after drug administration

Trial design

Single-center, randomized, double-blind, placebo-controlled, single dose escalation study to investigate safety, tolerability and pharmacokinetics of BAY 1021189 in Asian (Chinese) healthy male subjects
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Basic Science
Allocation
Randomized
Blinding
N/A
Assignment
N/A
Trial Arms
N/A