Trial Condition(s):
Clinical Pharmacology
Interaction study of vericiguat with midazolam in healthy male subjects
Trial Purpose
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.
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | ||
|---|---|---|---|
Locations Investigative Site Mönchengladbach, Germany, 41061 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Primary Outcome
- Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) of Midazolam in PlasmaTimeframe: 0 hour (h) pre-dose to 48 h post-dose
- Maximum Observed Concentration (Cmax) of Midazolam in PlasmaTimeframe: 0 hour (h) pre-dose to 48 h post-dose
Additional Information
Not Available
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