Trial Condition(s):

Clinical Pharmacology

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

Bayer Identifier:

15812

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2013-000769-35

Study Completed

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.

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
15
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Verquvo (Vericiguat, BAY1021189)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Berlin, Germany, 13353

Status
Completed
 

Trial Design