Single-center, open-label study in healthy male subjects to evaluate the absolute bioavailability of a 10 mg oral dose of vericiguat (BAY 1021189) (as IR tablets following a high-fat, high-calorie meal) in comparison to an intravenous, 14C-labeled micro-dose (20 µg) of vericiguat
- Conditions
- heart failure10019280
- Registration Number
- NL-OMON42434
- Lead Sponsor
- Bayer HealthCare AG, Clinical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
- healthy male subjects
- 18-55 years old inclusive
- race wite (i.e. caucasian)
- BMI between 18-30kg/m2
- GI disorders, history of coronary artery disease, symptomatic postural hypotension, asthma bronchiale/other airway disease, myasthenia gravis, apnea after drug intake, lactose intolerance, severe allergies
- smoking more than 10 cigarettes per day
- donation of approximately 500 mL of blood/plasmapheresis within 3 months until 4 weeks before study drug administration, donation of more than 100 mL blood 1 week before study drug administration
- systolic BP below 100 or above 145 mmHg, diastolic BP below 60 or above 95 mmHg, heart rate below 50 or above 95 beats/min
- positive hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), human deficiency virus antibodies (anti-HIV 1+2)
-participation in another study with a radiation burden of > 0.1 mSv in the peroid of 1 year prior to screening
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary variables for this study are:<br /><br>* AUC divided by dose (AUC/D) of vericiguat and 14C labeled vericiguat<br /><br>* Cmax divided by dose (Cmax/D) of vericiguat and 14C labeled vericiguat<br /><br>* Absolute bioavailability (F) of vericiguat</p><br>
- Secondary Outcome Measures
Name Time Method <p>NA</p><br>