Trial Condition(s):
Clinical Pharmacology
BAY 1021189 Mass Balance Study
Bayer Identifier:
15817
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site GRONINGEN, Netherlands, 9728 NZ | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Single center, open-label, non-randomized, non-placebo-controlled study to investigate the pharmacokinetics, metabolic disposition and mass balance after single administration of 5 mg [14C]BAY 1021189 (oral solution) in healthy male subjects
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Basic Science
Allocation:
N/A
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Area Under the Concentration Versus Time Curve From Zero to Infinity in Plasma (AUC) of VericiguatTimeframe: 0 hour (h) Pre-dose to 336 h post-dose
- Maximum Observed Drug Concentration in Plasma (Cmax) of VericiguatTimeframe: 0 h Pre-dose to 336 h post-dose
- Area Under the Concentration Versus Time Curve From Zero to Infinity Divided by Dose per Kilogram Body Weight (AUCnorm) of Vericiguat and its MetabolitesTimeframe: 0 h Pre-dose to 336 h post-dose
- Maximum Observed Drug Concentration in Plasma Divided by Dose per Kilogram Body Weight (Cmax,norm) of Vericiguat and its MetabolitesTimeframe: 0 h Pre-dose to 336 h post-dose
- Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) of Radioactivity in Whole Blood and PlasmaTimeframe: 0 h Pre-dose to 336 h post-dose
- Area Under the Concentration Versus Time Curve From Zero to Infinity Divided by Dose per Kilogram Body Weight (AUCnorm) of Radioactivity in Whole Blood and PlasmaTimeframe: 0 h Pre-dose to 336 h post-dose
- Maximum Observed Drug Concentration (Cmax) of Radioactivity in Whole Blood and PlasmaTimeframe: 0 h Pre-dose to 336 h post-dose
- Maximum Observed Radioactivity Concentration Divided by Dose per Kilogram Body Weight (Cmax,norm) of Radioactivity in Whole Blood and PlasmaTimeframe: 0 h Pre-dose to 336 h post-dose
- Area Under the Concentration Versus Time Curve From Zero to the Last Data Point (AUC[0-tlast]) of Radioactivity in Whole Blood and PlasmaTimeframe: 0 h Pre-dose to 336 h post-dose
- Metabolite Profile in PlasmaTimeframe: 0 h Pre-dose to 336 h post-dose
- Metabolite Profile in UrineTimeframe: 0 h Pre-dose to 336 h post-dose
- Metabolite Profile in FecesTimeframe: 0 h Pre-dose to 336 h post-dose
- Cumulative Percentage of Amount of Radioactivity and Metabolites Excreted in Urine (%AE,ur)Timeframe: 0 h Pre-dose to 288h post-dose
- Cumulative Percentage of Amount of Radioactivity and Metabolites Excreted in Feces (%AE,fec)Timeframe: 0 h Pre-dose to 288h post-dose
- Area Under the Concentration Versus Time Curve From Zero to Infinity in Plasma (AUC) of Vericiguat Metabolite (M-1)Timeframe: 0 h Pre-dose to 336 h post-dose
- Maximum Observed Drug Concentration in Plasma (Cmax) of Vericiguat Metabolite (M-1)Timeframe: 0 h Pre-dose to 336 h post-dose
Additional Information
Not Available
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