check_circleStudy Completed
Heart failure
Bayer Identifier:
15813
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
A trial to learn how safe vericiguat (BAY1021189) is and the way the body absorbs, distributes and gets rid of vericiguat in participants with kidney disease and in age-, weight- and gender-matched healthy participants
Trial purpose
Vericiguat (BAY1021189) is under development to treat heart failure, a condition in in which the heart has trouble pumping blood through the body. Renal impairment which co-occurs in patients with heart failure is a common condition in which the kidneys are not filtering the blood as well as they should.
The goal of the study was to learn more about the safety of vericiguat (BAY1021189), how it was tolerated and the way the body absorbed, distributed and excreted the study dug given as a single oral dose of 2.5 mg tablet in participants with renal impairment and healthy participants matched for age-, gender-, and weight.
The participants stayed at the trial site for about 6 days. During this time, the doctors took blood and urine samples and checked the participants’ health. About 7-14 days after the participants took vericiguat (BAY1021189), the researchers checked the participants’ health again and asked about any medical problems they had.
The goal of the study was to learn more about the safety of vericiguat (BAY1021189), how it was tolerated and the way the body absorbed, distributed and excreted the study dug given as a single oral dose of 2.5 mg tablet in participants with renal impairment and healthy participants matched for age-, gender-, and weight.
The participants stayed at the trial site for about 6 days. During this time, the doctors took blood and urine samples and checked the participants’ health. About 7-14 days after the participants took vericiguat (BAY1021189), the researchers checked the participants’ health again and asked about any medical problems they had.
Key Participants Requirements
Sex
BothAge
18 - 79 YearsTrial summary
Enrollment Goal
39Trial Dates
June 2014 - January 2015Phase
Phase 1Could I Receive a placebo
NoProducts
Verquvo (Vericiguat, BAY1021189)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Kiel, 24105, Germany |
Primary Outcome
- AUC of vericiguatArea under the concentration vs. time curve from zero to infinity after single dose administrationdate_rangeTime Frame:Up to 96 hours
- Cmax of vericiguatMaximum observed drug concentration in measured matrix after single dose administrationdate_rangeTime Frame:Up to 96 hours
- AUC of vericiguat's metabolite M-1Area under the concentration vs. time curve from zero to infinity after single dose administrationdate_rangeTime Frame:Up to 96 hours
- Cmax of vericiguat's metabolite M-1Maximum observed drug concentration in measured matrix after single dose administrationdate_rangeTime Frame:Up to 96 hours
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
Non-randomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
5