Trial Condition(s):
Pharmacology, clinical
BAY63-2521, POC SD invasive hemodynamics in patient with PH
Bayer Identifier:
11874
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
EU CT Number:
Not Available
Study Completed
Trial Purpose
Primary objective: To investigate the safety, tolerability, pharmacokinetics, impact on pulmonary and systemic hemodynamics, and gas exchange of BAY 63-2521.
Study Part A: Individual dose titration of 3 single doses of BAY 63-2521 solution was performed.
Study Part B: Single dose of BAY 63-2521 solution was tested.
Inclusion Criteria
- Subjects 18 - 80 years of age with suspected pulmonary hypertension due to pulmonary arterial hypertension, chronic thromboembolic pulmonary hypertension, or interstitial lung disease.
Exclusion Criteria
- Certain pre-existing lung disease - Certain pre-existing cardiovascular disorders - PaO2/FiO2 <50 mmHg - PaCO2 >55 mmHg - Deficiencies of blood coagulation, inherited or acquired blood coagulation disorders - Disseminated intravascular coagulation - Deficient platelet function, thrombocytopenia - Evidence for major bleeding or intracranial hemorrhage - Latent bleeding risk such as diabetic retinopathy, history of gastrointestinal bleeding, colitis ulcerosa - Severe hepatic insufficiency - Renal insufficiency - Primary or secondary immunodeficiencies - Previous therapeutic radiation of lungs or mediastinum - Concomitant medication not allowed - Elevated intracranial pressure - Women with childbearing potential without reliable contraceptive measures, pregnancy, breast feeding - Subjects whose underlying disease was unlikely to permit them to survive the study - Sickle cell anemia
Trial Summary
Enrollment Goal
19
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 Gießen, Germany, 35392 | 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 and gas exchange of a single-dose of BAY 63-2521 solution in patients with pulmonary hypertension in a non-randomized, non-blinded, dose escalation design.
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
4
Primary Outcome
- AUCArea under the plasma concentration vs time curve from zero to infinity after single dose for BAY 63-2521 and its metabolite M1 (BAY 60-4552)Timeframe: Pre-dose and up to 24 h post-dose in Part A and up to 48 h post-dose in Part B
- AUC/DAUC divided by dose (mg) for BAY 63-2521 and its metabolite M1 (BAY 60-4552)Timeframe: Pre-dose and up to 24 h post-dose in Part A and up to 48 h post-dose in Part B
- AUCnormAUC divided by dose per kg body weight for BAY 63-2521 and its metabolite M1 (BAY 60-4552)Timeframe: Pre-dose and up to 24 h post-dose in Part A and up to 48 h post-dose in Part B
- CmaxMaximum drug concentration in plasma after single dose administration for BAY 63-2521 and its metabolite M1 (BAY 60-4552)Timeframe: Pre-dose and up to 24 h post-dose in Part A and up to 48 h post-dose in Part B
- Cmax/DMaximum drug concentration in plasma after single dose administration divided by dose (mg) for BAY 63-2521 and its metabolite M1 (BAY 60-4552)Timeframe: Pre-dose and up to 24 h post-dose in Part A and up to 48 h post-dose in Part B
- Cmax,normMaximum drug concentration in plasma after single dose administration divided by dose (mg) per kg body weight for BAY 63-2521 and its metabolite M1 (BAY 60-4552)Timeframe: Pre-dose and up to 24 h post-dose in Part A and up to 48 h post-dose in Part B
- Number of participants with adverse eventsTimeframe: Approximately 2 days per subject
- Swan-Ganz hemodynamics- Mean right atrial pressure - Pulmonary arterial pressure - Pulmonary capillary wedge pressure - Heart rate - Systemic blood pressure - Cardiac output - Pulmonary vascular resistance - Pulmonary vascular resistance index - Systemic vascular resistance - Systemic vascular resistance index - Cardiac indexTimeframe: Measured up to 6 h in both the study parts
- Blood gas analysisPartial oxygen pressure, partial carbon dioxide pressure, arterial oxygen saturation, mixed venous oxygen tension, venous oxygen saturationTimeframe: Performed up to 3 h in both the parts
- MIGETMultiple inert gas elimination technique (MIGET) included: - Total ventilation - Total perfusion - Dead-space ventilation - Low ventilation-perfusion ratio (V/Q) perfusion - Normal V/Q perfusion - Ventilation-perfusion distribution - Intrapulmonary shunt flowTimeframe: Performed up to 3 h in both the parts
Secondary Outcome
- tmaxTime to reach maximum drug concentration in plasma after single dose for BAY 63-2521 and its metabolite M1 (BAY 60-4552)Timeframe: Pre-dose and up to 24 h post-dose in Part A and up to 48 h post-dose in Part B
- t½Half-life associated with the terminal slope for BAY 63-2521 and its metabolite M1 (BAY 60-4552)Timeframe: Pre-dose and up to 24 h post-dose in Part A and up to 48 h post-dose in Part B
- MRTMean residence time for BAY 63-2521 and its metabolite M1 (BAY 60-4552)Timeframe: Pre-dose and up to 24 h post-dose in Part A and up to 48 h post-dose in Part B
- AUC(0-tn)AUC from time 0 to the last data point for BAY 63-2521 and its metabolite M1 (BAY 60-4552)Timeframe: Pre-dose and up to 24 h post-dose in Part A and up to 48 h post-dose in Part B
Additional Information
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