Trial Condition(s):

Clinical Pharmacology

Vericiguat absolute bioavailability using microdosing technology

Bayer Identifier:

17114

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2015-001568-20

Study Completed

Trial Purpose

The primary objective of this study was to evaluate the absolute bioavailability of an oral dose of 10 mg vericiguat (BAY 1021189) given as two 5 mg immediate release (IR) tablets following a high-fat, high-calorie meal in comparison to a 14C-labeled micro-dose of vericiguat (20 microgram) administered as a 30-min intravenous (i.v.) infusion, 4 h after oral tablet dosing.

The secondary objectives were to further characterize the PK of vericiguat and its metabolite M1 (BAY 1222707), and to investigate the safety and tolerability of vericiguat.

Inclusion Criteria
- Healthy male.
- Age: 18 to 55 years (inclusive) at the first screening examination/visit.
- Race: white (i.e. Caucasian).
- Body mass index (BMI): ≥18.0 and ≤30.0 kg/m2.
Exclusion Criteria
- Incompletely cured pre existing diseases for which it can be assumed that they may alter the absorption, distribution, metabolism, elimination and effects of the study drugs.
- Known 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 impair the subject’s ability to complete the study in the opinion of the investigator.
- History of coronary artery disease.
- Symptomatic postural hypotension.
- History of asthma bronchiale or other airway disease.
- History or suspicion of drug and/or alcohol dependencies.
- Myasthenia gravis.
- History of apnea after drug intake beyond scheduled anesthesia.

Trial Summary

Enrollment Goal
10
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

GRONINGEN, Netherlands, 9728 NZ

Status
Completed
 

Trial Design