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:

2014-003982-13

Study Completed

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
32
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Verquvo (Vericiguat, BAY1021189)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Mönchengladbach, Germany, 41061

Status
Completed
 

Trial Design