Trial Condition(s):
Clinical Pharmacology
Interaction study of vericiguat with midazolam in healthy male subjects
Bayer Identifier:
15815
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
EU CT Number:
Not Available
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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