check_circleStudy Completed

Pharmacology, Clinical

Bayer Identifier:

11874

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2005-002522-64

EU CT Number:

Not Available
BAY63-2521, POC SD invasive hemodynamics in patient with PH

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.

Key Participants Requirements

Sex

Both

Age

18 - 80 Years
  • - Subjects 18 - 80 years of age with suspected pulmonary hypertension due to pulmonary arterial hypertension, chronic thromboembolic pulmonary hypertension, or interstitial lung disease.

  • - 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
September 2005 - July 2006
Phase
Phase 1
Could I Receive a placebo
No
Products
Adempas (Riociguat, BAY63-2521)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Gießen, 35392, Germany

Primary Outcome

  • AUC
    Area 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)
    date_rangeTime Frame:
    Pre-dose and up to 24 h post-dose in Part A and up to 48 h post-dose in Part B
    enhanced_encryption
    Safety Issue:
    No
  • AUC/D
    AUC divided by dose (mg) for BAY 63-2521 and its metabolite M1 (BAY 60-4552)
    date_rangeTime Frame:
    Pre-dose and up to 24 h post-dose in Part A and up to 48 h post-dose in Part B
    enhanced_encryption
    Safety Issue:
    No
  • AUCnorm
    AUC divided by dose per kg body weight for BAY 63-2521 and its metabolite M1 (BAY 60-4552)
    date_rangeTime Frame:
    Pre-dose and up to 24 h post-dose in Part A and up to 48 h post-dose in Part B
    enhanced_encryption
    Safety Issue:
    No
  • Cmax
    Maximum drug concentration in plasma after single dose administration for BAY 63-2521 and its metabolite M1 (BAY 60-4552)
    date_rangeTime Frame:
    Pre-dose and up to 24 h post-dose in Part A and up to 48 h post-dose in Part B
    enhanced_encryption
    Safety Issue:
    No
  • Cmax/D
    Maximum drug concentration in plasma after single dose administration divided by dose (mg) for BAY 63-2521 and its metabolite M1 (BAY 60-4552)
    date_rangeTime Frame:
    Pre-dose and up to 24 h post-dose in Part A and up to 48 h post-dose in Part B
    enhanced_encryption
    Safety Issue:
    No
  • Cmax,norm
    Maximum 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)
    date_rangeTime Frame:
    Pre-dose and up to 24 h post-dose in Part A and up to 48 h post-dose in Part B
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with adverse events
    date_rangeTime Frame:
    Approximately 2 days per subject
    enhanced_encryption
    Safety Issue:
    Yes
  • 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 index
    date_rangeTime Frame:
    Measured up to 6 h in both the study parts
    enhanced_encryption
    Safety Issue:
    Yes
  • Blood gas analysis
    Partial oxygen pressure, partial carbon dioxide pressure, arterial oxygen saturation, mixed venous oxygen tension, venous oxygen saturation
    date_rangeTime Frame:
    Performed up to 3 h in both the parts
    enhanced_encryption
    Safety Issue:
    No
  • MIGET
    Multiple 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 flow
    date_rangeTime Frame:
    Performed up to 3 h in both the parts
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • tmax
    Time to reach maximum drug concentration in plasma after single dose for BAY 63-2521 and its metabolite M1 (BAY 60-4552)
    date_rangeTime Frame:
    Pre-dose and up to 24 h post-dose in Part A and up to 48 h post-dose in Part B
    enhanced_encryption
    Safety Issue:
    No
  • t½
    Half-life associated with the terminal slope for BAY 63-2521 and its metabolite M1 (BAY 60-4552)
    date_rangeTime Frame:
    Pre-dose and up to 24 h post-dose in Part A and up to 48 h post-dose in Part B
    enhanced_encryption
    Safety Issue:
    No
  • MRT
    Mean residence time for BAY 63-2521 and its metabolite M1 (BAY 60-4552)
    date_rangeTime Frame:
    Pre-dose and up to 24 h post-dose in Part A and up to 48 h post-dose in Part B
    enhanced_encryption
    Safety Issue:
    No
  • AUC(0-tn)
    AUC from time 0 to the last data point for BAY 63-2521 and its metabolite M1 (BAY 60-4552)
    date_rangeTime Frame:
    Pre-dose and up to 24 h post-dose in Part A and up to 48 h post-dose in Part B
    enhanced_encryption
    Safety Issue:
    No

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

Additional Information

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