An Open Label Single and Repeat Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-17299425 in Patients with Traumatic Brain Injury.
- Conditions
- Traumatic Brain Injury (TBI)
- Registration Number
- EUCTR2007-000280-17-BE
- Lead Sponsor
- Janssen-Cilag International N.V
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Subjects with traumatic head injury (GCS: greater than or equal to 8/15 before ventilation) and requiring ventilation and intra-cranial pressure monitoring.
Male or female between 18 and 65 years of age, inclusive.
Female subjects: post menopausal as defined by FSH and LH, or previously documented sterilization.
Legally acceptable representatives (relatives/guardians) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are allowing the subject to participate in the study.
Moderately increased ICP (ICP>20 mmHG and CPP greater than or equal to 60mmHg) after initial response to <20mmHg), to a maximum of 3 ventricular drainages.
HB greater than or equal to 8 g/dL.
Thrombocytes count greater than or equal to 100.000/microLiters.
Potassium less than or equal to 5mmol/L.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range
Major injury (multitrauma) or disease outside the CNS causing significant vital organ- or blood counts dysfunction (eg Disseminated Intravascular Coagulation (DIC), serious hepatic or kidney failure, (Acute Respiratory Distress Syndrome (ARDS) etc.).
Subjects who already received specific ICP lowering therapy, other than drainage, before being dosed with JNJ-17299425.
Rapid increase of ICP expected to result in death of the subject.
Relevant abnormal values for hematology, clinical chemistry or urinalysis at screening. In particular, a significant abnormal hematology profile, or unacceptable bleeding diathesis.
Any known significant history or family history of anemia, hemolytic or otherwise, or autoimmune disease.
Significant non-brain trauma.
On CT scan, compressive hematoma and more than 2 cm midline shift resulting into cranial surgery, or other features that would make the need for surgery unlikely.
Any unknown significant history or family history of thrombocytopenia (eg idiopathic thrombocytopenia).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine whether JNJ-17299425 can reduce the increased intracranial pressure (ICP) after traumatic brain injury. The primary pharmacodynamic (PD) parameter is the reduction of ICP; the percentage reduction will be characterized, as well as the absolute reduction, and the reduction below 20 mmHg. The duration of the ICP reduction will also be analyzed. Additionally, the safety, tolerability and maximum safe dose of JNJ-17299425.;Secondary Objective: To determine the effects of JNJ-17299425 on cerebral perfusion pressure (CPP), mean arterial blood pressure (MABP), and clinical scoring assessment.<br>To investigate the pharmacokinetic (PK) profile of JNJ-17299425. To investigate a PK/PD relationship of JNJ-17299425.;Primary end point(s): Pharmacodynamic parameter of ICP.<br>Percentage of subjects with an ICP reduction to below 20 mmHg and the duration of the ICP reduction.<br>Safety and tolerabilility and determination of maximum safe dose of JNJ 17299425.
- Secondary Outcome Measures
Name Time Method