check_circleStudy Completed

Clinical pharmacology

Bayer Identifier:

16964

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

EU CT Number:

Not Available
Single and multiple dose phase I study in China

Trial purpose

The primary objective of this study was:
• To investigate the pharmacokinetics and pharmacodynamics of BAY1021189 after a single oral dose and multiple oral doses once daily over 7 days of 1.25 mg, 5 mg and 10 mg as IR tablets in Chinese healthy male subjects under fed condition

The secondary objectives of this study were:
• To investigate the safety and tolerability of BAY 1021189 in Chinese healthy male subjects
• To investigate the influence of different food (high fat/high calorie breakfast or standardized breakfast) on the pharmacokinetics of BAY1021189 in Chinese healthy adult male subjects

Key Participants Requirements

Sex

Male

Age

18 - 45 Years
  • - Chinese healthy male volunteers, age 18-45 years

  • - Incompletely cured pre-existing diseases for which it was assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs was not normal
    - Known hypersensitivity to the study drugs (active substances or excipients of the preparations)
    - 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
    - Subjects with lactose intolerance
    - Regular use of medicines
    - Regular use of therapeutic or recreational drugs
    - Use of systemic or topical medicines or substances which opposed the study objectives or which had the potential to influence them within 4 weeks before the first study drug administration

Trial summary

Enrollment Goal
46
Trial Dates
September 2016 - October 2017
Phase
Phase 1
Could I Receive a placebo
Yes
Products
Verquvo (Vericiguat, BAY1021189)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Beijing, 100083, China

Primary Outcome

  • AUC
    Area under the plasma concentration vs time curve from zero to infinity after single (first) dose
    date_rangeTime Frame:
    Day 0 to Day 4
  • AUC/D
    AUC divided by dose (mg)
    date_rangeTime Frame:
    Day 0 to Day 4
  • AUCnorm
    Area under the curve divided by dose per kg body weight
    date_rangeTime Frame:
    Day 0 to Day 4
  • AUC(0-24)
    AUC from time 0 to 24 hours after administration
    date_rangeTime Frame:
    Day 0 to Day 4 and Day 4 to Day 5
  • AUC(0-24)/D
    AUC(0-24) by dose (mg)
    date_rangeTime Frame:
    Day 0 to Day 4 and Day 4 to Day 5
  • AUC(0-24)norm
    AUC(0-24) divided by dose (mg) per kg body weight
    date_rangeTime Frame:
    Day 0 to Day 4 and Day 4 to Day 5
  • Cmax
    Maximum drug concentration in plasma after single dose administration
    date_rangeTime Frame:
    Day 0 to Day 4 and Day 4 to Day 5
  • Cmax/D
    Maximum drug concentration in plasma after single dose administrationdivided by dose (mg)
    date_rangeTime Frame:
    Day 0 to Day 4 and Day 4 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 0 to Day 4 and Day 4 to Day 5
  • tmax
    Time to reach maximum drug concentration in plasma after single (first) dose
    date_rangeTime Frame:
    Day 4 to Day 5
  • AUCτ,ss/D
    AUCτ,ss/D divided by dose (mg)
    date_rangeTime Frame:
    Day 10 to Day 14
  • AUCτ,ss,norm
    AUCτ,ss divided by dose (mg) per kg body weight
    date_rangeTime Frame:
    Day 10 to Day 14
  • Cmax,ss
    Maximum drug concentration in plasma at steady state during a dosage interval
    date_rangeTime Frame:
    Day 10 to Day 14
  • Cmax,ss/D
    Maximum drug concentration in plasma at steady state divided by dose (mg)
    date_rangeTime Frame:
    Day 10 to Day 14
  • 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 10 to Day 14
  • Heart rate over 1 min
    date_rangeTime Frame:
    Up to 4 h after administration of study drug
  • Blood pressure
    date_rangeTime Frame:
    Up to 4 h after administration of study drug
  • Number of participants with treatment-emergent adverse events (TEAEs)
    date_rangeTime Frame:
    From first study drug administration until 30 days after the last study drug administration

Secondary Outcome

  • AUC(0-tlast)
    AUC from time 0 to the last data point
    date_rangeTime Frame:
    Day 0 to Day 4
  • AUC(0-tlast)/D
    AUC(0-tlast) by dose (mg)
    date_rangeTime Frame:
    Day 0 to Day 4
  • AUC(0- tlast)norm
    AUC(0-tlast) divided by dose (mg) per kg body weight
    date_rangeTime Frame:
    Day 0 to Day 4
  • tmax
    Time to reach maximum drug concentration in plasma after single (first) dose
    date_rangeTime Frame:
    Day 0 to Day 4 and Day 10 to Day 14
  • t1/2
    Half-life associated with the terminal slope
    date_rangeTime Frame:
    Day 0 to Day 4 and Day 10 to Day 14
  • MRT
    Mean residence time
    date_rangeTime Frame:
    Day 0 to Day 4 and Day 10 to Day 14
  • CL/F
    Total body clearance of drug from plasma calculated after oral administration (apparent oral clearance)
    date_rangeTime Frame:
    Day 0 to Day 4 and Day 10 to Day 14
  • AE,ur
    Amount of drug excreted via urine
    date_rangeTime Frame:
    Day 0 to Day 4
  • AE,ur(0-24)
    Amount of drug excreted into urine from 0 to 24 hours after administration
    date_rangeTime Frame:
    Day 0 to Day 4 and Day 10 to Day 14
  • %AE,ur
    Rate of amount of drug excreted into urine to the administered dose
    date_rangeTime Frame:
    Day 0 to Day 4
  • %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 0 to Day 4 and Day 10 to Day 14
  • CLR
    Renal body clearance of drug
    date_rangeTime Frame:
    Day 0 to Day 4 and Day 10 to Day 14
  • Vz/F
    Apparent volume of distribution during terminal phase after oral administration
    date_rangeTime Frame:
    Day 0 to Day 4
  • PTF
    Peak trough fluctuation
    date_rangeTime Frame:
    Day 10 to Day 14
  • Accumulation ratio RACmax
    Accumulation ratio calculated from Cmax after multiple dosing and Cmax after single dosing
    date_rangeTime Frame:
    Day 10 compared to Day 4
  • Accumulation ratio RAAUC
    Accumulation ratio calculated from AUCτ after multiple dosing and AUCτ after single dosing
    date_rangeTime Frame:
    Day 10 compared to Day 4

Trial design

Single-center, randomized, double-blind, placebo-controlled, single-dose and multiple-dose, parallel-group study to investigate pharmacokinetics, pharmacodynamics, safety and tolerability of BAY 1021189 in Chinese healthy male subjects under fed condition
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Basic Science
Allocation
Randomized
Blinding
N/A
Assignment
N/A
Trial Arms
4