Trial Condition(s):
Interaction study of vericiguat with midazolam in healthy male subjects
15815
Not Available
Not Available
The primary objective was to investigate the influence of multiple doses of 10 mg vericiguat once daily given as a single oral dose on the pharmacokinetics of a single oral dose of 7.5 mg midazolam.
The secondary objective was to assess the influence of multiple doses of 10 mg vericiguat once daily given as a single oral dose on the safety and tolerability of a single oral dose of midazolam.
- Healthy male subject. - Age: 18 to 55 years (inclusive) at the first screening examination / visit. - Race: White - Body Mass Index (BMI): above / equal 18.0 and below / equal 30.0 kg/m2
- Incompletely cured pre-existing diseases for which it could have been assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs was not normal. - Known gastrointestinal (GI) disorders (e.g. stomach ulcers, duodenal ulcers, GI bleeding) or inflammatory bowel disease (e.g. Crohn’s disease, ulcerative colitis) - Medical disorder that would have impaired the subject’s ability to complete the study in the opinion of the investigator. - History of coronary artery disease (CAD) - Symptomatic postural hypotension (e.g. dizziness, lightheadedness). - History of bronchial asthma or other airway disease. - History of dependencies. - Myasthenia gravis. - History of apnea after drug intake beyond scheduled anesthesia. - Known hypersensitivity to the study drugs (active substances or excipients of the preparations) or to midazolam.
Locations | Status | |
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Locations Investigative Site Mönchengladbach, Germany, 41061 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Single-center, randomized, non-blinded, non-placebo-controlled, twofold crossover study to investigate the influence of multiple doses of 10 mg OD vericiguat on pharmacokinetics, safety and tolerability of a single oral dose of 7.5 mg midazolam in comparison to a single dose of 7.5 mg midazolam alone in healthy male subjects
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Basic Science
Allocation:
Randomized
Blinding:
N/A
Assignment:
Crossover Assignment
Trial Arms:
2
Not Available