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

NCT04722484 | Completed Phase 1

• 2 other identifiers: 158132013-004762-34
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (4)

• AUC of vericiguat

  Area under the concentration vs. time curve from zero to infinity after single dose administration

  Up to 96 hours

• Cmax of vericiguat

  Maximum observed drug concentration in measured matrix after single dose administration

  Up to 96 hours

• AUC of vericiguat's metabolite M-1

  Area under the concentration vs. time curve from zero to infinity after single dose administration

  Up to 96 hours

• Cmax of vericiguat's metabolite M-1

  Maximum observed drug concentration in measured matrix after single dose administration

  Up to 96 hours

Study Arms (5)

Patients with normal creatine clearance (CLCR)

EXPERIMENTAL

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)

Drug: Vericiguat (BAY1021189)

Normal renal function (Healthy subjects)

EXPERIMENTAL

Subjects with creatinine clearance at pre-profile day \>80 ml/min

Drug: Vericiguat (BAY1021189)

Mildly impaired renal function

EXPERIMENTAL

Subjects with creatinine clearance at pre-profile day in the range of 50-80 ml/min

Drug: Vericiguat (BAY1021189)

Moderately impaired renal function

EXPERIMENTAL

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

Drug: Vericiguat (BAY1021189)

Severely impaired renal function

EXPERIMENTAL

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

Drug: Vericiguat (BAY1021189)

Interventions

Vericiguat (BAY1021189) DRUG

Oral single dose of 2.5 mg (2 x 1.25 mg immediate release tablet)

Mildly impaired renal function; Moderately impaired renal function; Normal renal function (Healthy subjects); Patients with normal creatine clearance (CLCR); Severely impaired renal function

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Acute nephritis
• Any organ transplant in the past 5 years
• Severe cerebrovascular or cardiac disorders, e.g. myocardial infarction less than 6 months prior to dosing, congestive heart failure of New York Heart Association grade III or IV, severe arrhythmia requiring anti-arrhythmic treatment
• Percutaneous transluminal coronary angioplasty or coronary artery bypass graft less than 6 months prior to dosing
• Diagnosed malignancy within the past 5 years

Sponsors & Collaborators

• Bayer: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Unknown Facility

Kiel, Schleswig-Holstein, 24105, Germany

Location

Related Links

• Click here to find results for studies related to Bayer products

MeSH Terms

Conditions

Heart Failure

Interventions

vericiguat

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: January 25, 2021
• Study Start: June 12, 2014
• Primary Completion: January 22, 2015
• Study Completion: January 22, 2015
• Last Updated: January 25, 2021

Record last verified: 2021-01

Locations

DE (1)