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

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 - Vericiguat absolute bioavailability using microdosing technology

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42434

Enrollment

Registered

2015-09-15

Start date

2015-10-07

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

heart failure

Interventions

All subjects will receive the following treatments: Treatment A: single oral dose of 10 mg vericiguat administered as two 5 mg IR tablets in the fed state, i.e. after a high-fat, high calorie breakfa

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - healthy male subjects - 18-55 years old inclusive - race wite (i.e. caucasian) - BMI between 18-30kg/m2

Exclusion criteria

Exclusion criteria: - 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

Design outcomes

Primary

Measure	Time frame
The primary variables for this study are: * AUC divided by dose (AUC/D) of vericiguat and 14C labeled vericiguat * Cmax divided by dose (Cmax/D) of vericiguat and 14C labeled vericiguat * Absolute bioavailability (F) of vericiguat	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)