Study 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

Inclusion Criteria
- 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
Exclusion Criteria
- 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

Trial Dates

June 2013 - January 2014

Phase

Phase 1

Could I Receive a placebo

Products

Verquvo (Vericiguat, BAY1021189)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed		Berlin, 13353, Germany

Primary Outcome

Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC) of BAY1021189
Time Frame:
PK samples were taken between 0 to 72 hours
Maximum Observed Drug Concentration (Cmax) of BAY1021189
Time Frame:
PK samples were taken between 0 to 72 hours
Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
Time 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
Time 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
Time 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
Time 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
Time 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
Time 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
Time Frame:
PK samples were taken between 0 to 72 hours
Time to Reach Maximum Drug Plasma Concentration (tmax) of BAY1021189
Time Frame:
PK samples were taken between 0 to 72 hours
Half-life Associated With the Terminal Slope (t1/2) of BAY1021189 in Plasma
Time Frame:
PK samples were taken between 0 to 72 hours
Total Body Clearance of Drug from Plasma (CL/F) of BAY1021189
Time Frame:
PK samples were taken between 0 to 72 hours
Apparent Volume of Distribution During Terminal Phase (Vz/F) of BAY1021189 in Plasma
Time Frame:
PK samples were taken between 0 to 72 hours
Mean Residence Time (MRT) of BAY1021189 in Plasma
Time Frame:
PK samples were taken between 0 to 72 hours
Percentage (%) of Amount of Renal Excretion (%AEur) of BAY1021189
Time Frame:
Urine collection: 0 to 72 hours
Amount of Renal Excretion (AEur in milligram) of BAY1021189
Time Frame:
Urine collection: 0 to 72 hours
Renal Body Clearance (CLR) of BAY1021189
Time Frame:
Urine collection: 0 to 72 hours

Trial design

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Basic Science

Allocation

Randomized

Blinding

N/A

Assignment

N/A

Trial Arms