Trial Condition(s):
Hypertension, Pulmonary, Pulmonary Disease, Chronic Obstructive
Single dose study in patients with chronic obstructive pulmonary disease (COPD) associated pulmonary hypertension.
Bayer Identifier:
12915
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Study Completed
Trial Purpose
This study is to demonstrate the safety, tolerability, pharmakokinetic and pharmacodynamic effect of a single oral dose of BAY63-2521 in patients with pulmonary hypertension due to chronic obstructive pulmonary disease (COPD).
Inclusion Criteria
- Patients with pulmonary hypertension due to COPD, undergoing routine invasive measurement of hemodynamic parameters. - Catheters for measurement of hemodynamic parameters (PAP [pulmonary artery pressure], PCWP [pulmonary capillary wedge pressure], CO [cardiac output], SBP [systolic blood pressure]) must be in place independent of the trial.
Exclusion Criteria
- Acute exacerbation of COPD, - Pre-existing lung disease other than COPD, - Acute or severe chronic left heart failure, - Severe coronary artery disease, - Uncontrolled arterial hypertension; - Severe left ventricular hypertrophy, - Congenital or acquired valvular or myocardial disease, - Systolic blood pressure < 100 mmHg, - Heart rate < 55 bpm or >105 bpm, - PaO2 (arterial partial oxygen pressure)/FiO2 (fraction of inspired oxygen) < 50 mmHg, - PaCO2 (arterial partial pressure of carbon dioxide) > 55 mmHg, - Severe hepatic insufficiency, - Severe renal insufficiency.
Trial Summary
Enrollment Goal
23
Trial Dates
Phase
1
Could I receive a placebo?
No
Products
Adempas (Riociguat, BAY63-2521)
Accepts Healthy Volunteers
No
Where to Participate
Loading...
Locations
| Locations | |
|---|---|
Locations Investigative Site Greifswald, Germany, 17475 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Gießen, Germany, 35392 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Löwenstein, Germany, 74245 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dresden, Germany, 01307 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site München, Germany, 81377 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bad Nauheim, Germany, 61231 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Heidelberg, Germany, 69126 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Proof of concept study to investigate safety, tolerability, pharmacokinetics and the impact on pulmonary and systemic hemodynamics, gas exchange and lung function parameters of a single-dose of BAY63-2521 IR-tablet in patients with COPD associated pulmonary hypertension in an non-randomized, non-blinded design
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Swan-Ganz hemodynamics - Maximal change from baseline at day 1 of mean pulmonary artery pressure (PAPmean)Timeframe: From baseline up to 4 hours after administration
- Swan-Ganz hemodynamics - Maximal change from baseline at day 1 of pulmonary vascular resistance (PVR)Timeframe: From baseline up to 4 hours after administration
- Area under the plasma concentration versus time curve from zero to infinity (AUC) of riociguat and metabolite M1 after single dose of riociguatTimeframe: Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose
- Area under the plasma concentration versus time curve from zero to infinity divided by dose (AUC/D) of riociguat and metabolite M1 after single dose of riociguatTimeframe: Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose
- Area under the plasma concentration versus time curve from zero to infinity divided by dose per kg body weight (AUCnorm) of riociguat and metabolite M1 after single dose of riociguatTimeframe: Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose
- Maximum drug concentration in plasma (Cmax) of riociguat and metabolite M1 after single dose of riociguatTimeframe: Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose
- Maximum drug concentration in plasma divided by dose (Cmax/D) of riociguat and metabolite M1 after single dose of riociguatTimeframe: Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose
- Maximum drug concentration in plasma divided by dose per kg body weight (Cmax,norm) of riociguat and metabolite M1 after single dose of riociguatTimeframe: Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose
Secondary Outcome
- Swan-Ganz hemodynamics - Maximal change from baseline at day 1 of mean right atrial pressure (RAPmean)Timeframe: From baseline up to 4 hours after administration
- Swan-Ganz hemodynamics - Maximal change from baseline at day 1 of systolic pulmonary artery pressure (PAPsyst)Timeframe: From baseline up to 4 hours after administration
- Swan-Ganz hemodynamics - Maximal change from baseline at day 1 of diastolic pulmonary artery pressure (PAPdiast)Timeframe: From baseline up to 4 hours after administration
- Swan-Ganz hemodynamics - Maximal change from baseline at day 1 of pulmonary capillary wedge pressure (PCWP)Timeframe: From baseline up to 4 hours after administration
- Swan-Ganz hemodynamics - Maximal change from baseline at day 1 of heart rate (HR)Timeframe: From baseline up to 4 hours after administration
- Swan-Ganz hemodynamics - Maximal change from baseline at day 1 of systolic blood pressure (SBP)Timeframe: From baseline up to 4 hours after administration
- Swan-Ganz hemodynamics - Maximal change from baseline at day 1 of diastolic blood pressure (DBP)Timeframe: From baseline up to 4 hours after administration
- Swan-Ganz hemodynamics - Maximal change from baseline at day 1 of mean arterial pressure (MAP)Timeframe: From baseline up to 4 hours after administration
- Swan-Ganz hemodynamics - Maximal change from baseline at day 1 of cardiac output (CO)Timeframe: From baseline up to 4 hours after administration
- Swan-Ganz hemodynamics - Maximal change from baseline at day 1 of pulmonary vascular resistance index (PVRI)Timeframe: From baseline up to 4 hours after administration
- Swan-Ganz hemodynamics - Maximal change from baseline at day 1 of systemic vascular resistance (SVR)Timeframe: From baseline up to 4 hours after administration
- Swan-Ganz hemodynamics - Maximal change from baseline at day 1 of systemic vascular resistance index (SVRI)Timeframe: From baseline up to 4 hours after administration
- Swan-Ganz hemodynamics - Maximal change from baseline at day 1 of cardiac indexTimeframe: From baseline up to 4 hours after administration
- Blood gas analysis - Percentage change from baseline at 2 hours post dose of arterial partial oxygen pressure (PaO2)Timeframe: Baseline and 2 hours post dose
- Blood gas analysis - Percentage change from baseline at 2 hours post dose of arterial partial pressure of carbon dioxide (PaCO2)Timeframe: Baseline and 2 hours post dose
- Blood gas analysis - Percentage change from baseline at 2 hours post dose of venous oxygen pressure (PvO2)Timeframe: Baseline and 2 hours post dose
- Blood gas analysis - Percentage change from baseline at 2 hours post dose of arterial oxygen saturation (SaO2)Timeframe: Baseline and 2 hours post dose
- Blood gas analysis - Percentage change from baseline at 2 hours post dose of venous oxygen saturation (SvO2)Timeframe: Baseline and 2 hours post dose
- Lung function - Percentage change from baseline at 2 hours post dose of forced expiratory volume in 1 second (FEV1)Timeframe: Baseline and 2 hours post dose
- Lung function - Percentage change from baseline at 2 hours post dose of percent of predicted FEV1Timeframe: Baseline and 2 hours post dose
- Lung function - Percentage change from baseline at 2 hours post dose of forced vital capacity (FVC)Timeframe: Baseline and 2 hours post dose
- Lung function - Percentage change from baseline at 2 hours post dose of percent of predicted FVCTimeframe: Baseline and 2 hours post dose
- Lung function - Percentage change from baseline at 2 hours post dose of FEV1/FVCTimeframe: Baseline and 2 hours post dose
- Lung function - Percentage change from baseline at 2 hours post dose of total lung capacity (TLC)Timeframe: Baseline and 2 hours post dose
- Lung function - Percentage change from baseline at 2 hours post dose of percent of predicted TLCTimeframe: Baseline and 2 hours post dose
- Lung function - Percentage change from baseline at 2 hours post dose of residual volume (RV)Timeframe: Baseline and 2 hours post dose
- Lung function - Percentage change from baseline at 2 hours post dose of percent of predicted RVTimeframe: Baseline and 2 hours post dose
- Lung function - Percentage change from baseline at 2 hours post dose of maximal expiratory flow at 75% of expiratory vital capacity (MEF75)Timeframe: Baseline and 2 hours post dose
- Lung function - Percentage change from baseline at 2 hours post dose of maximal expiratory flow at 50% of expiratory vital capacity (MEF50)Timeframe: Baseline and 2 hours post dose
- Lung function - Percentage change from baseline at 2 hours post dose of maximal expiratory flow at 25% of expiratory vital capacity (MEF25)Timeframe: Baseline and 2 hours post dose
- Lung function - Percentage change from baseline at 2 hours post dose of total airway resistance (Raw)Timeframe: Baseline and 2 hours post dose
- Lung function - Percentage change from baseline at 2 hours post dose of vital capacity (VC)Timeframe: Baseline and 2 hours post dose
- Lung function - Percentage change from baseline at 2 hours post dose of percent of predicted VCTimeframe: Baseline and 2 hours post dose
- Lung function - Percentage change from baseline at 2 hours post dose of diffusing capacity of the lung for carbon monoxide (DLCO)Timeframe: Baseline and 2 hours post dose
- Lung function - Percentage change from baseline at 2 hours post dose of total lung capacity at the time when the DLCO is measured (alveolar volume, VA)Timeframe: Baseline and 2 hours post dose
- Lung function - Percentage change from baseline at 2 hours post dose of specific diffusing capacityTimeframe: Baseline and 2 hours post dose
- Multiple inert gas elimination technique (MIGET) analysis - Change from baseline at 1 hour post dose of total ventilation (V)Timeframe: Baseline and 1 hour post dose
- Multiple inert gas elimination technique (MIGET) analysis - Change from baseline at 1 hour post dose of total perfusion (Q)Timeframe: Baseline and 1 hour post dose
- Multiple inert gas elimination technique (MIGET) analysis - Change from baseline at 1 hour post dose of dead space ventilationTimeframe: Baseline and 1 hour post dose
- Multiple inert gas elimination technique (MIGET) analysis - Change from baseline at 1 hour post dose of low V/Q perfusionTimeframe: Baseline and 1 hour post dose
- Multiple inert gas elimination technique (MIGET) analysis - Change from baseline at 1 hour post dose of normal V/Q perfusionTimeframe: Baseline and 1 hour post dose
- Multiple inert gas elimination technique (MIGET) analysis - Change from baseline at 1 hours post dose of ventilation-perfusion distribution presented as standard deviation (SD) of perfusionTimeframe: Baseline and 1 hour post dose
- Multiple inert gas elimination technique (MIGET) analysis - Change from baseline at 1 hour post dose of ventilation-perfusion distribution presented as standard deviation (SD) of ventilationTimeframe: Baseline and 1 hour post dose
- Multiple inert gas elimination technique (MIGET) analysis - Change from baseline at 1 hour post dose of intrapulmonary shunt flowTimeframe: Baseline and 1 hour post dose
- Time to reach maximum drug concentration in plasma (tmax) of riociguat and metabolite M1 after single dose of riociguatTimeframe: Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose
- Half-life associated with the terminal slope (t1/2) of riociguat and metabolite M1 after single dose of riociguatTimeframe: Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose
- Mean residence time (MRT) of riociguat and metabolite M1 after single dose of riociguatTimeframe: Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose
- Area under the plasma concentration verse time curve from zero to the last data point (AUC0-tn) of riociguat and metabolite M1 after single dose of riociguatTimeframe: Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose
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