Trial Condition(s):
Influence of age and gender on the pharmacokinetics of a single oral dose of 5 mg BAY 1021189 as immediate-release tablet in healthy male and female subjects
15816
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The primary objective of the study was to investigate the influence of age and gender on the pharmacokinetics (PK) of a single oral dose of 5 mg vericiguat as an IR tablet in young and elderly healthy male and female subjects.
The secondary objectives of the study were to assess the safety and tolerability of vericiguat.
- Age: 18 to 45 years or >= 65 years (according to the group the subjects had been assigned to). - Race : white. - Body mass index (BMI): above/equal to 18.0 kg/m2 and below/equal to 29.9 kg/m2.
- Medical disorder, condition, or history of such that would have impaired the subjects ability to participate or complete this study, in the opinion of the investigator or the sponsor. - Incompletely cured pre-existing diseases, for which it was assumed that the absorption, distribution, metabolism, elimination, and effects of the study drugs would not be normal. - Relevant diseases within the last 4 weeks prior to the first study drug administration. - No past or present hepatic impairment. - No past renal impairment. - For the population of young female and young male subjects: no present renal impairment, including but not limited to glomerulonephritis, glomerulosclerosis, diabetic nephropathy, as determined by an estimated glomerular filtration rate (eGFR) >90 mL/min/1.73 m2, and normal urine tests. - For the population of elderly female and elderly male subjects: no present renal impairment, including but not limited to glomerulonephritis; glomerulosclerosis; diabetic nephropathy, as determined by eGFR >30 mL/min/1.73 m2; normal urine tests; urinary protein-to-creatinine ratio <=200 mg/g (creatinine); and urinary albumin-to-creatinine ratio <30 mg/g (creatinine). - No past or present diagnosed maligna s (active substances or excipients of the preparations). - Known severe allergies, non-allergic drug reactions, or multiple drug allergies.
Locations | Status | |
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Locations Investigative Site Miami, United States, 33014 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Study to investigate the influence of age and gender on the pharmacokinetics of a single oral dose of 5 mg BAY 1021189 as immediate-release tablet in a randomized, double-blind, placebo-controlled, group-comparison design in healthy male and female subjects
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Basic Science
Allocation:
Randomized
Blinding:
N/A
Assignment:
N/A
Trial Arms:
6
Not Available