check_circleStudy Completed
Clinical pharmacology
Bayer Identifier:
15817
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
EU CT Number:
Not Available
BAY 1021189 Mass Balance Study
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.
• 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.
Key Participants Requirements
Sex
MaleAge
45 - 65 YearsTrial summary
Enrollment Goal
6Trial Dates
April 2014 - February 2015Phase
Phase 1Could I Receive a placebo
NoProducts
Verquvo (Vericiguat, BAY1021189)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | GRONINGEN, 9728 NZ, Netherlands |
Primary Outcome
- Area Under the Concentration Versus Time Curve From Zero to Infinity in Plasma (AUC) of Vericiguatdate_rangeTime Frame:0 hour (h) Pre-dose to 336 h post-dose
- Maximum Observed Drug Concentration in Plasma (Cmax) of Vericiguatdate_rangeTime Frame: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 Metabolitesdate_rangeTime Frame: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 Metabolitesdate_rangeTime Frame: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 Plasmadate_rangeTime Frame: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 Plasmadate_rangeTime Frame:0 h Pre-dose to 336 h post-dose
- Maximum Observed Drug Concentration (Cmax) of Radioactivity in Whole Blood and Plasmadate_rangeTime Frame: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 Plasmadate_rangeTime Frame: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 Plasmadate_rangeTime Frame:0 h Pre-dose to 336 h post-dose
- Metabolite Profile in Plasmadate_rangeTime Frame:0 h Pre-dose to 336 h post-dose
- Metabolite Profile in Urinedate_rangeTime Frame:0 h Pre-dose to 336 h post-dose
- Metabolite Profile in Fecesdate_rangeTime Frame:0 h Pre-dose to 336 h post-dose
- Cumulative Percentage of Amount of Radioactivity and Metabolites Excreted in Urine (%AE,ur)date_rangeTime Frame:0 h Pre-dose to 288h post-dose
- Cumulative Percentage of Amount of Radioactivity and Metabolites Excreted in Feces (%AE,fec)date_rangeTime Frame: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)date_rangeTime Frame:0 h Pre-dose to 336 h post-dose
- Maximum Observed Drug Concentration in Plasma (Cmax) of Vericiguat Metabolite (M-1)date_rangeTime Frame:0 h Pre-dose to 336 h post-dose
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
Basic ScienceAllocation
N/ABlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1