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:
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Wuppertal, Germany, 42113 | Contact Us: E-mail: [email protected] Phone: Not Available |
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:
8
Primary Outcome
- Mean Maximum Decrease in Blood PressureTimeframe: 24.5 hours (h) pre-dose of nitroglycerin to 4 h post-dose of nitroglycerin
- Mean Change in Blood Pressure by TimeTimeframe: 24.5 h pre-dose of nitroglycerin to 4 h post-dose of nitroglycerin
- Mean Maximum Increase in Heart Rate (HR)Timeframe: 24.5 h pre-dose of nitroglycerin to 4 h post-dose of nitroglycerin
- Mean Change in Heart RateTimeframe: 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 ParametersTimeframe: 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)Timeframe: 24.5 h pre-dose of nitroglycerin to 24 h post-dose of nitroglycerin
Additional Information
Not Available
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