Trial Condition(s):

Clinical Pharmacology

Single dose escalation Phase I study in Asians

Bayer Identifier:

15837

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

Study Completed

Trial Purpose

The primary objective of this study was to investigate the safety and tolerability of BAY 1021189 after single oral doses of 1.25 mg, 5 mg and 10 mg administered as one or multiples of 1.25 mg immediate-release(IR) tablet(s) in Asian (Chinese) healthy male subjects.

The secondary objectives of this study are to investigate
pharmacokinetics and pharmacodynamics of BAY1021189 in Asian (Chinese) healthy male subjects.

Inclusion Criteria
- Healthy male subject
-  Age: 21 to 45 years (inclusive) at the first screening examination / visit
- Chinese healthy male subject
- Body weight ≥50 kg, Body Mass Index (BMI) was between 19 and 27 kg/m² (inclusive)
Exclusion Criteria
- Incompletely cured pre-existing diseases for which it could be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs were not normal
- Known hypersensitivity to the study drugs (active substances or excipients of the preparations) or to the study drugs, the control agent and / or to inactive constituents
- Known severe allergies, non-allergic drug reactions, or multiple drug allergies
- Relevant diseases within the last 4 weeks prior to the first study drug administration
- Febrile illness within 1 week before the first study drug administration
- Regular use of medicines
- Regular use of therapeutic or recreational drugs
- Use of systemic or topical medicines or substances which could oppose the study objectives or which could influence them within 4 weeks before the first study drug administration
- Smoking more than 20 cigarettes daily
- Regular daily consumption of more than 800 mL of usual beer or the equivalent quantity of approximately 32 g of alcohol in another form

Trial Summary

Enrollment Goal
36
Trial Dates
black-arrow
Phase
1
Could I receive a placebo?
Yes
Products
Verquvo (Vericiguat, BAY1021189)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Singapore, Singapore, 529889

Status
Completed
 

Trial Design