Trial Condition(s):

Clinical Pharmacology

Single and multiple dose escalation study in Japanese subjects

Bayer Identifier:

15836

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

Study Completed

Trial Purpose

The primary objective of this study is to
• Investigate the safety and tolerability of BAY1021189 after single and multiple doses of 1.25, 5, 7.5 and 10 mg in Japanese healthy male subjects

The secondary objectives are to
• Investigate the pharmacodynamics and pharmacokinetics of BAY1021189 in Japanese healthy adult male subjects
• Exploratorily investigate the influence of food intake on the pharmacokinetics of BAY1021189 in Japanese healthy adult male subjects

Inclusion Criteria
- Japanese healthy male subjects
- 20 to 40 years of age
- 17.6 to 26.4 kg / m² of Body mass index (BMI)
Exclusion Criteria
- Subjects with conspicuous findings in medical history, and screening or Day 1 before
the first study drug administration examination results
- Subjects with diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
- Subjects with known hypersensitivity to the study drugs (active substances, or excipients of the preparations)
- Subjects with a history of severe allergies, non-allergic drug reactions, or multiple drug allergies
- Subjects with lactose intolerance
- Subjects with relevant diseases within the last 4 weeks prior to the first study drug administration
- Subjects with febrile illness within 1 week before the first study drug administration
- Subjects with regular use of medicines
- Subjects with regular use of therapeutic or recreational drugs

Trial Summary

Enrollment Goal
48
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

Kagoshima, Japan, 890-0081

Status
Completed
 

Trial Design