Trial Condition(s):

Clinical Pharmacology

BAY 1021189 Mass Balance Study

Bayer Identifier:

15817

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2013-005115-27

Study Completed

Trial Purpose

The primary objectives of this study were:
• to measure the cumulative amount as well as the time course of drug-related, radiolabeled material excreted in urine and feces following a single oral dose of 5 mg [14C] vericiguat
• to characterize the metabolic pattern in plasma, urine and feces and to identify metabolites where possible
• to quantify total radioactivity in blood and plasma
• to quantify parent vericiguat and metabolites circulating in plasma (reported separately).

The secondary objective of this study was to assess the safety and tolerability of 5 mg vericiguat administered as an oral solution in healthy subjects.

Inclusion Criteria
- Gender: male
- Ethnicity: White
- Age: 45 to 65 years (inclusive) at the first screening examination/visit
- Body mass index (BMI): above/equal 18.0 and below/equal 30.0 kg/m²
Exclusion Criteria
- Incompletely cured pre-existing diseases for which it could have been assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs were not normal
- Known or suspected hypersensitivity to vericiguat or to excipients in the formulation
- Known severe allergies, non-allergic drug reactions or multiple drug allergies
- Relevant diseases within the last 4 weeks prior to the administration of study drug
- Past or present renal impairment, including but not limited to glomerulonephritis, glomerulosclerosis, diabetic nephropathy, as determined by an estimated (MDRD formula) glomerular filtration rate (eGFR) > 90 mL/min/1.73 m2 and urine tests within clinically normal ranges
- Subjects with Gilbert’s syndrome (associated with the UGT1A1 promoter genotype)
- Febrile illness within 1 week before the first study drug administration
- Subjects with a history of malignant disease during the last 5 years
Regular use of nitrates and/or other NO donors and phosphodiesterase-5 inhibitors

Trial Summary

Enrollment Goal
6
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Verquvo (Vericiguat, BAY1021189)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

GRONINGEN, Netherlands, 9728 NZ

Status
Completed
 

Trial Design