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

Bayer HealthCare AG, Clinical Sciences0 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

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•- 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

发起方

Bayer HealthCare AG, Clinical Sciences