Investigation of Pharmacokinetics, Safety, Tolerability and Pharmacodynamic Effects of BAY1021189 in Male and Female Subjects With Renal Impairment and in Age-, Gender-, and Weight-matched Healthy Subjects Following a Single Oral Dose of 2.5 mg BAY1021189 in a Single-center, Non Randomized, Non-controlled, Non-blinded, Observational Study With Group Stratification

Bayer0 sites39 target enrollmentJune 12, 2014

ConditionsHeart Failure

InterventionsVericiguat (BAY1021189)

DrugsVericiguat (BAY1021189)

Overview

Phase: Phase 1
Intervention: Vericiguat (BAY1021189)
Conditions: Heart Failure
Sponsor: Bayer
Enrollment: 39
Primary Endpoint: AUC of vericiguat
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

June 12, 2014

End Date

January 22, 2015

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bayer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•For all subjects:
•Aged between 18 and 79 years (inclusive) with body mass index 18 to 34 kg/m\^2 (both inclusive)
•Women without childbearing potential; women of childbearing potential only if the pregnancy test was negative and a combination of condoms with a safe and highly effective contraception method was granted
•For subjects with renal impairment:
•With an estimated glomerular filtration rate (eGFR) \< 90 mL/min/1.73m\^2 determined from a serum creatinine control 2-14 days prior to dosing
•Stable renal disease, i.e. a serum creatinine value determined at least 3 months before the pre-study visit should not vary by more than 25% from the serum creatinine value determined at the pre-study visit
•For healthy subjects:
•eGFR ≥ 90 mL/min/1.73m\^2 determined from serum creatinine 2-14 days prior to dosing
•Healthy subjects with age-, weight- and gender- matched to renal impaired subjects

Exclusion Criteria

•For all subjects:
•Febrile illness within 1 week before the start of the study
•History of severe allergies, non-allergic drug reactions, or multiple drug allergies
•Hypersensitivity to the investigational drug, the control agent and/ or to inactive constituents
•Regular daily consumption of more than 1/2 liter of usual beer or the equivalent quantity of approximately 20 g of alcohol in another form or more than 1 liter of xanthine-containing beverages or more than 10 cigarettes
•Positive testing in the drug screening
•Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), human immune deficiency virus antibodies (anti-HIV 1+2)
•Donation of more than 100 mL of blood in the preceding 4 weeks or 500 mL in the preceding 3 months
•Relevant deviation from the normal range in clinical chemistry, hematology, coagulation or urinalysis as judged by the investigator For subjects with renal impairment
•Acute renal failure

Arms & Interventions

Moderately impaired renal function

Subjects with creatinine clearance at pre-profile day in the range of 30-\<50 ml/min

Intervention: Vericiguat (BAY1021189)

Severely impaired renal function

Subjects with creatinine clearance at pre-profile day \<30 ml/min

Intervention: Vericiguat (BAY1021189)

Patients with normal creatine clearance (CLCR)

Subjects with renal impairment according to their medical history and estimated glomerular filtration rate (eGFR) at screening but had normal creatinine clearance at the pre-profile day (-01day)

Intervention: Vericiguat (BAY1021189)