check_circleStudy Completed

Heart failure

Bayer Identifier:
16440
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
2012-004839-23
EU CT Number:
Not Available
Multiple dose food effect Phase I study of BAY1021189

Trial purpose

The primary objective of this study was to investigate the PK of BAY 1021189 after single oral doses of 1.25 mg, 2.5 mg, 5 mg and 10 mg administered as IR tablets in the fed state (high-fat, high-calorie breakfast).

The secondary objective of this study was to assess safety and tolerability of BAY 1021189.

Key Participants Requirements

Sex

Male

Age

18 - 45 Years
  • - Healthy male subject
    - Age: 18 to 45 years (inclusive) at the first screening visit
    - Ethnicity: White
    - Body mass index (BMI): above/equal 18.0 and below/equal 29.9 kg/m²

  • - Incompletely cured pre-existing diseases for which it could be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs was not normal
    - Known hypersensitivity to the study drug (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 study drug administration
    - Febrile illness within 1 week before study drug administration
    - History of postural syncopes
    - Regular use of medicines
    - Regular use of therapeutic or recreational drugs (eg carnitin products, anabolics, high dose vitamins)
    - Use of medication within 2 weeks before study drug administration which could oppose the study objectives or which might influence them

Trial summary

Enrollment Goal
16
Trial Dates
January 2013 - September 2013
Phase
Phase 1
Could I Receive a placebo
No
Products
Verquvo (Vericiguat, BAY1021189)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Köln, 51063, Germany

Primary Outcome

  • Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity Divided by Dose (AUC/D) of BAY1021189
    date_rangeTime Frame:
    0-72 hours (h)
  • Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity Divided by Dose per Kilogram Body Weight (AUCnorm) of BAY1021189
    date_rangeTime Frame:
    0-72 h
  • Maximum Drug Plasma Concentration Divided by Dose (Cmax/D) of BAY1021189
    date_rangeTime Frame:
    0-72 h
  • Maximum Drug Plasma Concentration Divided by Dose per Kilogram Body Weight (Cmax,norm) of BAY1021189
    date_rangeTime Frame:
    0-72 h
  • Number of Subjects With Treatmentemergent Adverse Events (TEAEs)
    date_rangeTime Frame:
    From start of study treatment up to the end of followup visit (1 week after last dose)
  • Number of Subjects With Clinically Relevant Time- or Dose-related Changes in Laboratory, Vital Signs and Electrocardiogram (ECG) Parameters
    date_rangeTime Frame:
    From start of study treatment up to the end of followup visit (1 week after last dose)

Secondary Outcome

  • Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC) of BAY1021189
    date_rangeTime Frame:
    0-72 h
  • Maximum Drug Plasma Concentration (Cmax) of BAY1021189
    date_rangeTime Frame:
    0-72 h
  • Time to Reach Maximum Drug Plasma Concentration (tmax) of BAY1021189
    date_rangeTime Frame:
    0-72 h
  • Halflife Associated With the Terminal Slope (t1/2) of BAY1021189 in Plasma
    date_rangeTime Frame:
    0-72 h
  • Total Body Clearance of Drug from Plasma (CL/F) of BAY1021189
    date_rangeTime Frame:
    0-72 h
  • Apparent Volume of Distribution During Terminal Phase (Vz/F) of BAY1021189 in Plasma
    date_rangeTime Frame:
    0-72 h
  • Area Under the Plasma Concentration Versus Time Curve From Zero to Last Data Point (AUC[0tlast]) of BAY1021189
    date_rangeTime Frame:
    0-72 h
  • Area Under the Plasma Concentration Versus Time Curve From Zero to Last Data Point Divided by Dose per Kilogram Body Weight (AUC[0tlast] norm) of BAY1021189
    date_rangeTime Frame:
    0-72 h
  • Mean Residence Time (MRT) of BAY1021189 in Plasma
    date_rangeTime Frame:
    0-72 h

Trial design

Relative bioavailability study to investigate pharmacokinetics, safety and tolerability following administration of 1.25 mg, 2.5 mg, 5 mg and 10 mg BAY 1021189 as IR tablets following a high fat, high calorie meal in 16 healthy male subjects in a randomized, open label, fourfold crossover design
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Basic Science
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
4