Study Completed

Clinical pharmacology

Bayer Identifier:

17115

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2014-001235-36

EU CT Number:

Not Available

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

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.

Key Participants Requirements

Sex

Male

Age

40 - 60 Years

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

Trial Dates

August 2014 - July 2015

Phase

Phase 1

Could I Receive a placebo

Yes

Products

Verquvo (Vericiguat, BAY1021189)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed		Wuppertal, 42113, Germany

Primary Outcome

Mean Maximum Decrease in Blood Pressure
Time Frame:
24.5 hours (h) pre-dose of nitroglycerin to 4 h post-dose of nitroglycerin
Mean Change in Blood Pressure by Time
Time Frame:
24.5 h pre-dose of nitroglycerin to 4 h post-dose of nitroglycerin
Mean Maximum Increase in Heart Rate (HR)
Time Frame:
24.5 h pre-dose of nitroglycerin to 4 h post-dose of nitroglycerin
Mean Change in Heart Rate
Time Frame:
24.5 h pre-dose of nitroglycerin to 4 h post-dose of nitroglycerin
Number of Subjects With Clinically Significant Events Related to Heart Rate, Blood pressure, and Safety Laboratory Parameters
Time Frame:
From start of study treatment up to follow-up (7 days after the last study drug administration)
Number of Subjects With Abnormal, Clinically Significant Events Related to Electrocardiogram (ECG)
Time Frame:
24.5 h pre-dose of nitroglycerin to 24 h post-dose of nitroglycerin

Trial design

Evaluation of the effect of 0.2 mg sublingually administered nitroglycerin after pretreatment with 5 mg vericiguat on safety, tolerability and blood pressure in a randomized, placebocontrolled, double-blind crossover study in two cohorts of healthy male subjects aged 40 to 60 years

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Basic Science

Allocation

Randomized

Blinding

N/A

Assignment

N/A

Trial Arms