Trial Condition(s):

Clinical Pharmacology

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

Bayer Identifier:

15816

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

Inclusion Criteria
- 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.
Exclusion Criteria
- 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.

Trial Summary

Enrollment Goal
56
Trial Dates
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Phase
1
Could I receive a placebo?
Yes
Products
Verquvo (Vericiguat, BAY1021189)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Miami, United States, 33014

Status
Completed
 

Trial Design