check_circleStudy Completed

Clinical pharmacology

Bayer Identifier:

15812

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2013-000769-35

EU CT Number:

Not Available
An Exploratory Phase I, Randomized, Open Label Two Fold Cross-Over Study to Determine the Effect of Ketoconazole on the Pharmacokinetics of a Single Oral Dose of 1.25 mg BAY 1021189 in Healthy Male Subjects

Trial purpose

The primary objective is to investigate the influence of multiple doses of 200 milligram (mg) ketoconazole twice daily, on the pharmacokinetics (PK) of BAY1021189 given as a single oral dose of 1.25 mg in comparison to a single oral dose of 1.25 mg BAY1021189 alone.

Key Participants Requirements

Sex

Male

Age

18 - 45 Years
  • - Healthy male subject
    - Age: 18 to 45 years (inclusive) at the 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 can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
    - Known hypersensitivity to the study drug (active substances or excipients of the preparations) or to any imidazole containing antifungal
    - 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
    - Intake of foods or beverages containing grapefruit within 2 weeks before the first study drug administration
    - Donation of blood of approximately 500 mL or plasmapheresis within 3 months before study drug administration
    - Donation of more than 100 mL of blood within 4 weeks before study drug administration

Trial summary

Enrollment Goal
15
Trial Dates
June 2013 - January 2014
Phase
Phase 1
Could I Receive a placebo
No
Products
Verquvo (Vericiguat, BAY1021189)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Berlin, 13353, Germany

Primary Outcome

  • Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC) of BAY1021189
    date_rangeTime Frame:
    PK samples were taken between 0 to 72 hours
  • Maximum Observed Drug Concentration (Cmax) of BAY1021189
    date_rangeTime Frame:
    PK samples were taken between 0 to 72 hours
  • Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
    date_rangeTime Frame:
    From start of study treatment up to the last followup visit (within 12 weeks after last dose)
  • Number of Subjects With Clinically Relevant Changes in Laboratory, Vital Signs and Electrocardiogram (ECG) Parameters
    date_rangeTime Frame:
    From start of study treatment up to the last followup visit (within 12 weeks after last dose)

Secondary Outcome

  • Area Under the Plasma Concentration Versus Time Curve From Zero to Last Data Point (AUC[0tlast]) of BAY1021189
    date_rangeTime Frame:
    PK samples were taken between 0 to 72 hours
  • 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:
    PK samples were taken between 0 to 72 hours
  • Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC[024]) of BAY1021189
    date_rangeTime Frame:
    PK samples were taken between 0 to 24 hours
  • Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours Divided by Dose per Kilogram Body Weight (AUC[024], norm) of BAY1021189
    date_rangeTime Frame:
    PK samples were taken between 0 to 24 hours
  • Maximum Observed Drug Concentration Divided by Dose per Kilogram Body Weight (Cmax,norm) of BAY1021189
    date_rangeTime Frame:
    PK samples were taken between 0 to 72 hours
  • Time to Reach Maximum Drug Plasma Concentration (tmax) of BAY1021189
    date_rangeTime Frame:
    PK samples were taken between 0 to 72 hours
  • Half-life Associated With the Terminal Slope (t1/2) of BAY1021189 in Plasma
    date_rangeTime Frame:
    PK samples were taken between 0 to 72 hours
  • Total Body Clearance of Drug from Plasma (CL/F) of BAY1021189
    date_rangeTime Frame:
    PK samples were taken between 0 to 72 hours
  • Apparent Volume of Distribution During Terminal Phase (Vz/F) of BAY1021189 in Plasma
    date_rangeTime Frame:
    PK samples were taken between 0 to 72 hours
  • Mean Residence Time (MRT) of BAY1021189 in Plasma
    date_rangeTime Frame:
    PK samples were taken between 0 to 72 hours
  • Percentage (%) of Amount of Renal Excretion (%AEur) of BAY1021189
    date_rangeTime Frame:
    Urine collection: 0 to 72 hours
  • Amount of Renal Excretion (AEur in milligram) of BAY1021189
    date_rangeTime Frame:
    Urine collection: 0 to 72 hours
  • Renal Body Clearance (CLR) of BAY1021189
    date_rangeTime Frame:
    Urine collection: 0 to 72 hours

Trial design

An Exploratory Phase I, Randomized, Open Label Two Fold Cross-Over Study to Determine the Effect of Ketoconazole on the Pharmacokinetics of a Single Oral Dose of 1.25 mg BAY 1021189 in Healthy Male Subjects
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Basic Science
Allocation
Randomized
Blinding
N/A
Assignment
N/A
Trial Arms
2