Trial Condition(s):

Clinical Pharmacology

Evaluation of safety, tolerability and the pharmacodynamic effect after treatment of vericiguat and nitroglycerin

Bayer Identifier:

17115

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2014-001235-36

Study Completed

Trial Purpose

The primary objective of this study was to assess safety and tolerability of this combination.

The secondary objective of this study was to evaluate the pharmacodynamic interaction (effect on BP and HR) between vericiguat 5.0 mg and a 0.2 mg of sublingual nitroglycerin.

Inclusion Criteria
- Healthy male subject
- Age: 40 to 60 years (inclusive) at the first screening examination
- Race: 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 could not be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
- History of coronary artery disease (CAD)
- Suspected CAD after exercise ECG or echocardiogram, confirmed by external cardiologist
- Symptomatic postural hypotension (eg dizziness, lightheadedness)
- History of bronchial asthma or other airway disease
- Medical disorder that would have impaired the subject´s ability to complete the study in the opinion of the Investigator
- 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

Trial Summary

Enrollment Goal
39
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

Wuppertal, Germany, 42113

Status
Completed
 

Trial Design