Clareo Health | Impact of Multiple Doses of BAY63-2521 on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Patients With Interstitial Lung Disease (ILD) Associated Pulmonary Hypertension (PH)
Impact of Multiple Doses of BAY63-2521 on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Patients With Interstitial Lung Disease (ILD) Associated Pulmonary Hypertension (PH)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosis of an interstitial lung disease (usual interstitial pneumonia \[UIP\], nonspecific interstitial pneumonia \[NSIP\] or sarcoidosis) with high resolution CT and a total lung capacity (TLC) ≤ 90% or scleroderma associated pulmonary arterial hypertension (PAH) with total lung capacity (TLC) ≤ 80%.
Interstitial lung disease (ILD) must have been stable for at least 3 months (decrease in forced vital capacity (FVC)\< 10% and diffusing capacity of lung for carbon monoxide (DLco) \< 15 % in 3 months), i.e. no significant changes in pulmonary function testing and stable medication in terms of ILD (e.g., corticosteroids, immunosuppressants)
Mean pulmonary vascular resistance (PVR) \> 400 dyne sec cm-5 or mean pulmonary arterial pressure (PAP mean) \> 30 mmHg
Hemodynamic parameters at baseline (PAP, PCWP, cardiac output \[CO\], systemic mean arterial pressure \[SAP\])
High resolution computer tomography (HRCT) (should not be older than 12 months prior start of the study)
Heart rate \> 55 beats per minute (BPM) and \< 105 BPM at rest
Systolic blood pressure (SBP) \> 90 mmHg
World Health Organisation (WHO) functional class II, III and IV
6 Minute Walking Test (6MWT) \> 100m and \< 450 m
Stable controlled arterial hypertension according to current guidelines
Women of childbearing potential will be included in the study if the pregnancy test is negative and combination of condoms with a safe and highly effective contraception method (hormonal contraception with implants or combined oral contraceptives, certain intra-uterine devices \[IUDs\]) is granted.
You may not be if
Co-medication:
* Patients pretreated with specific medication for pulmonary arterial hypertension (PAH) like endothelin receptor antagonists, prostaglandins or phosphodiesterase type 5 (PDE 5) blockers are excluded from the trial.
* Requirement for concomitant use of nitrates are contraindicated.
Pre-existing clinically relevant lung disease other than ILD including.
* Bronchial asthma and Chronic Obstructive Pulmonary Disease (COPD) with a forced expiratory volume in one second (FEV1)/FVC \<60% pred., active tuberculosis
* Pulmonary hypertension of another WHO group (I, II, IV and V)
* Severe congenital abnormalities of the lungs, thorax and diaphragm
* Clinical or radiological evidence of a pulmovenoocclusive disease (PVOD)
Systemic hemodynamics
* Acute or severe chronic left heart failure (ejection fraction (EF) \< 50%)
* Severe coronary artery disease (CAD; EF \< 50%); CAD patients must be asymptomatic and stable
* Congenital or acquired valvular or myocardial disease if clinically significant apart from tricuspid valvular insufficiency due to pulmonary hypertension
* Moderate or severe hepatic insufficiency (Child-Pugh Class Band C and/or total bilirubin \> 2.5 mg/dl (0.043 mmol/L); and/or hepatic transaminases \>3 upper limit normal \[ULN\])
* Moderate or severe renal insufficiency (creatinine \> 2 mg/dl) or creatinine clearance according to Cockroft-Gault formula \< 35 mL/ min
