Study to Find the Highest Safe Dose of Soluble Guanylate Cyclase (sGC) Activator, BAY 1211163 Administered as Multiple Doses by Inhalation to Patients Who Cannot Breathe by Their Own and Suffer From a Type of Lung Failure That Causes Fluid to Build up in the Lungs Making Breathing Difficult (ARDS)

NCT04609943 | Terminated Phase 1 DMC

• 2 other identifiers: 204252019-004950-26
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 4

Brief Summary

With this study researchers want to find the highest safe dose of the soluble Guanylate Cyclase (sGC) Activator, BAY 1211163 and how safe and well the study drug works. Furthermore researchers want to gather information on the way the body absorbs, distributes and gets rid of the study drug given as increasing multiple doses by inhalation to patients who cannot breathe by their own and suffer from a type of lung failure that causes fluid to build up in the lungs making breathing difficult (ARDS)

Conditions

Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (2)

• Numbers of participants with treatment emergent adverse events (TEAEs)

  Up to 9 days

• Numbers of participants with dose limiting events (DLEs)

  A dose limiting event is defined as any of the TEAEs occurring during dosing with BAY1211163 and regarded by the investigators to be related to BAY1211163.

  Day 1 to 7 (may include Day 8)

Secondary Outcomes (1)

• Values of oxygenation index (OI)

  Up to 28 days

Study Arms (1)

BAY1211163

EXPERIMENTAL

Adult patients with moderate or severe Acute Respiratory Distress Syndrome (ARDS) diagnosis before study inclusion will receive BAY1211163.

Drug: BAY1211163

Interventions

BAY1211163 DRUG

Participants will receive one of the drug doses of BAY1211163 solution three times per day (TID) by inhalation for seven days.

BAY1211163

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Intubated, mechanically ventilated moderate or severe ARDS patients \[diagnosed according to Berlin definition of ARDS, including PEEP ≥ 5 cmH2O, X-ray, with PaO2/FiO2 between 80 and 200 mmHg (inclusive).
• Hypoxemia with PaO2/FiO2 between 80 and 200 mmHg (inclusive) maintained for at least 8 hours (recommend to be 12 hours) after screening, despite consent to follow recommendation on ventilator strategy and PEEP management.
• Time from intubation must be ≤ 96h.
• Male and non-pregnant female.

You may not qualify if:

• Moribund participants not expected to survive 24 hours (clinical decision).
• Expected duration of invasive mechanical ventilation less than 96 hours (clinical decision).
• History of pneumectomy or lung transplant.
• Current lung malignancy (including lung metastasis), or other malignancy requiring chemotherapy or radiation within the last month.
• History of chronic kidney disease and requiring renal replacement therapy dialysis at screening and/or baseline.
• Chronic liver disease Child-Pugh Class B and C.
• Hypoalbuminemia - serum albumin \< 2.0 g/dL.
• Acute left ventricular failure and/or Left Ventricular Ejection Fraction \< 30 %.
• Severe bronchopulmonal fistula.
• Clinical suspicion of pulmonary veno-occlusive disease.
• Heart right-sided endocarditis, tumors or mass.
• Rescue procedures already initiated at screening and/or Day 1.
• Use of co-medications involving moderate and strong inhibitors for CYP2C8 liver enzymes one week before assignment to intervention or during intervention.
• Off-label use of medication to treat Coronavirus SARS-CoV-2 virus unless recommended by scientific guidelines and accepted by DMC, investigator and sponsor.
• Plan to participate or past participation (within 30 days prior to Study Day 1) in other interventional studies.

Sponsors & Collaborators

• Bayer: lead

Study Sites (4)

Universitätsklinikum Giessen und Marburg

Giessen, Hesse, 35392, Germany

Location

Klinikum der Stadt Köln gGmbH - Krankenhaus Merheim

Cologne, North Rhine-Westphalia, 51109, Germany

Location

Sana-Klinikum Remscheid|Kardio, Angio, Pneumo u. Intensivmed

Remscheid, North Rhine-Westphalia, 42859, Germany

Location

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Related Links

• Click here to find further information and, after study completion, the study results according to Bayer's transparency standards.

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: October 30, 2020
• Study Start: November 24, 2020
• Primary Completion: August 17, 2023
• Study Completion: September 14, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4)