check_circleStudy Completed
Clinical pharmacology
Bayer Identifier:
15816
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
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.
The secondary objectives of the study were to assess the safety and tolerability of vericiguat.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
56Trial Dates
August 2013 - May 2014Phase
Phase 1Could I Receive a placebo
YesProducts
Verquvo (Vericiguat, BAY1021189)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Miami, 33014, United States |
Primary Outcome
- Area under the plasma concentration vs time curve from zero to infinity for total (bound and unbound) drug after single dose (AUC)date_rangeTime Frame:Pre-dose and up to 72 hours after study drug administration
- AUC divided by dose per kg body weight (AUCnorm)date_rangeTime Frame:Pre-dose and up to 72 hours after study drug administration
- Maximum total (bound and unbound) drug concentration in plasma after single dose administration (Cmax)date_rangeTime Frame:Pre-dose and up to 72 hours after study drug administration
- Cmax divided by dose per kg body weight (Cmax, norm)date_rangeTime Frame:Pre-dose and up to 72 hours after study drug administration
Secondary Outcome
- AUC from time 0 to the last data point (AUC (0-tlast))date_rangeTime Frame:Pre-dose and up to 72 hours after study drug administration
- AUC (0-tlast) divided by dose per kg body weight (AUC (0 tlast)norm)date_rangeTime Frame:Pre-dose and up to 72 hours after study drug administration
- Time to reach Cmax (tmax)date_rangeTime Frame:Pre-dose and up to 72 hours after study drug administration
- Half-life associated with the terminal slope (t1/2)date_rangeTime Frame:Pre-dose and up to 72 hours after study drug administration
- Mean residence time (MRT)date_rangeTime Frame:Pre-dose and up to 72 hours after study drug administration
- Total body clearance of drug calculated after extravascular administration (CL/F)date_rangeTime Frame:Pre-dose and up to 72 hours after study drug administration
- Apparent volume of distribution during terminal phase after extravascular administration (Vz/F)date_rangeTime Frame:Pre-dose and up to 72 hours after study drug administration
- Amount excreted (Ae,ur)date_rangeTime Frame:Pre-dose and up to 72 hours after study drug administration
- Number of participants with adverse eventsdate_rangeTime Frame:Up to day 7
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
Basic ScienceAllocation
RandomizedBlinding
N/AAssignment
N/ATrial Arms
6