Trial Condition(s):

Clinical Pharmacology

Single and multiple dose phase I study in China

Bayer Identifier:

16964

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

Study Completed

Trial Purpose

The primary objective of this study was:
• To investigate the pharmacokinetics and pharmacodynamics of BAY1021189 after a single oral dose and multiple oral doses once daily over 7 days of 1.25 mg, 5 mg and 10 mg as IR tablets in Chinese healthy male subjects under fed condition

The secondary objectives of this study were:
• To investigate the safety and tolerability of BAY 1021189 in Chinese healthy male subjects
• To investigate the influence of different food (high fat/high calorie breakfast or standardized breakfast) on the pharmacokinetics of BAY1021189 in Chinese healthy adult male subjects

Inclusion Criteria
- Chinese healthy male volunteers, age 18-45 years
Exclusion Criteria
- Incompletely cured pre-existing diseases for which it was assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs was not normal
- Known hypersensitivity to the study drugs (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 the first study drug administration
- Febrile illness within 1 week before the first study drug administration
- Subjects with lactose intolerance
- Regular use of medicines
- Regular use of therapeutic or recreational drugs
- Use of systemic or topical medicines or substances which opposed the study objectives or which had the potential to influence them within 4 weeks before the first study drug administration

Trial Summary

Enrollment Goal
46
Trial Dates
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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

Beijing, China, 100083

Status
Completed
 

Trial Design