check_circleStudy Completed

Clinical pharmacology

Bayer Identifier:

15816

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

EU CT Number:

Not Available
Influence of age and gender on the pharmacokinetics of a single oral dose of 5 mg BAY 1021189 as immediate-release tablet in healthy male and female subjects

Trial purpose

The primary objective of the study was to investigate the influence of age and gender on the pharmacokinetics (PK) of a single oral dose of 5 mg vericiguat as an IR tablet in young and elderly healthy male and female subjects.

The secondary objectives of the study were to assess the safety and tolerability of vericiguat.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - Age: 18 to 45 years or >= 65 years (according to the group the subjects had been assigned to).
    - Race : white.
    - Body mass index (BMI): above/equal to 18.0 kg/m2 and below/equal to 29.9 kg/m2.

  • - Medical disorder, condition, or history of such that would have impaired the subjects ability to participate or complete this study, in the opinion of the investigator or the sponsor.
    - Incompletely cured pre-existing diseases, for which it was assumed that the absorption, distribution, metabolism, elimination, and effects of the study drugs would not be normal.
    - Relevant diseases within the last 4 weeks prior to the first study drug administration.
    - No past or present hepatic impairment.
    - No past renal impairment.
    - For the population of young female and young male subjects: no present renal impairment, including but not limited to glomerulonephritis, glomerulosclerosis, diabetic nephropathy, as determined by an estimated glomerular filtration rate (eGFR) >90 mL/min/1.73 m2, and normal urine tests.
    - For the population of elderly female and elderly male subjects: no present renal impairment, including but not limited to glomerulonephritis; glomerulosclerosis; diabetic nephropathy, as determined by eGFR >30 mL/min/1.73 m2; normal urine tests; urinary protein-to-creatinine ratio <=200 mg/g (creatinine); and urinary albumin-to-creatinine ratio <30 mg/g (creatinine).
    - No past or present diagnosed maligna s (active substances or excipients of the preparations).
    - Known severe allergies, non-allergic drug reactions, or multiple drug allergies.

Trial summary

Enrollment Goal
56
Trial Dates
August 2013 - May 2014
Phase
Phase 1
Could I Receive a placebo
Yes
Products
Verquvo (Vericiguat, BAY1021189)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Miami, 33014, United States

Primary Outcome

  • Area under the plasma concentration vs time curve from zero to infinity for total (bound and unbound) drug after single dose (AUC)
    date_rangeTime Frame:
    Pre-dose and up to 72 hours after study drug administration
  • AUC divided by dose per kg body weight (AUCnorm)
    date_rangeTime Frame:
    Pre-dose and up to 72 hours after study drug administration
  • Maximum total (bound and unbound) drug concentration in plasma after single dose administration (Cmax)
    date_rangeTime Frame:
    Pre-dose and up to 72 hours after study drug administration
  • Cmax divided by dose per kg body weight (Cmax, norm)
    date_rangeTime Frame:
    Pre-dose and up to 72 hours after study drug administration

Secondary Outcome

  • AUC from time 0 to the last data point (AUC (0-tlast))
    date_rangeTime Frame:
    Pre-dose and up to 72 hours after study drug administration
  • AUC (0-tlast) divided by dose per kg body weight (AUC (0 tlast)norm)
    date_rangeTime Frame:
    Pre-dose and up to 72 hours after study drug administration
  • Time to reach Cmax (tmax)
    date_rangeTime Frame:
    Pre-dose and up to 72 hours after study drug administration
  • Half-life associated with the terminal slope (t1/2)
    date_rangeTime Frame:
    Pre-dose and up to 72 hours after study drug administration
  • Mean residence time (MRT)
    date_rangeTime Frame:
    Pre-dose and up to 72 hours after study drug administration
  • Total body clearance of drug calculated after extravascular administration (CL/F)
    date_rangeTime Frame:
    Pre-dose and up to 72 hours after study drug administration
  • Apparent volume of distribution during terminal phase after extravascular administration (Vz/F)
    date_rangeTime Frame:
    Pre-dose and up to 72 hours after study drug administration
  • Amount excreted (Ae,ur)
    date_rangeTime Frame:
    Pre-dose and up to 72 hours after study drug administration
  • Number of participants with adverse events
    date_rangeTime Frame:
    Up to day 7

Trial design

Study to investigate the influence of age and gender on the pharmacokinetics of a single oral dose of 5 mg BAY 1021189 as immediate-release tablet in a randomized, double-blind, placebo-controlled, group-comparison design in healthy male and female subjects
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Basic Science
Allocation
Randomized
Blinding
N/A
Assignment
N/A
Trial Arms
6