An Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics Study of JNJ-17299425 in Participants With Traumatic Brain Injury
An Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics Study of JNJ-17299425 in Participants With Traumatic Brain Injury
The purpose of this study is to evaluate safety, tolerability, pharmacokinetics (explores
 what the body does to the drug) and pharmacodynamics (the study of the action or effects a
 drug has on the body) of JNJ-17299425 in participants with traumatic brain injury (acute and
 chronic injuries to the brain, including the cerebral hemispheres, cerebellum, and brain
 stem).
This is an open-label (all people know the identity of the intervention), multi-center
 (conducted in more than one center), and exploratory study of single and repeat, escalating,
 intravenous (injection of a substance into a vein) doses of JNJ-17299425 in participants with
 traumatic brain injury. The study consists of 2 parts (Part 1 and Part 2), and each part will
 have 2 stages (Stage 1 and Stage 2). In Stage 1 of each part only standard care will be
 given, through sedation, analgesia and ventilation. If Intra cranial pressure (ICP) rises to
 greater than 20 millimeter of mercury (mmHG) after ventricular drainage, participants will
 enter Stage 2 of each part and will receive JNJ-17299425 (single dose in Part 1 and repeated
 dose in Part 2). During Part 1, safety and efficacy of JNJ-17299425 will be evaluated and
 during Part 2, safety, tolerability, pharmacokinetics and pharmacodynamics of repeated doses
 will be evaluated. Efficacy will primarily be evaluated by reduction in ICP. Blood samples
 will be collected for pharmacokinetic evaluation at pre and post administration of study
 treatment. Participants' safety will be monitored throughout the study.
Inclusion Criteria:

 -  Participants with traumatic head injury and requiring intracranial pressure (ICP)
 monitoring

 -  Post menopausal females, (or when known not to have menstruated for at least 12
 months), or previously documented sterilization

 -  Body Mass Index (BMI=weight per square height): 18 to 35 kilogram per square meter
 inclusive

 -  Legally acceptable representatives (relatives or 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 participant to participate in
 the study

 -  To participate in the optional pharmacogenomic component of this study, legally
 acceptable representatives (relatives or guardians) must have signed the informed
 consent form for pharmacogenomic research indicating willingness to participate in the
 pharmacogenomic component of the study (where local regulations permit). Refusal to
 consent for this component does not exclude a participant from participation in the
 clinical study

 Exclusion Criteria:

 -  Major injury (multi-trauma) or disease outside the central nervous system causing
 significant vital organ or blood counts dysfunction (for example, disseminated
 intravascular coagulation, serious hepatic or kidney failure, acute respiratory
 distress syndrome, etc)

 -  Participants who already received specific ICP lowering therapy, other than
 ventricular drainage, before being dosed with JNJ-17299425

 -  Rapid increase of ICP expected to result in death of the participant

 -  Relevant abnormal values for hematology, clinical chemistry or urinalysis at admission

 -  Any known significant history or family history of anemia, hemolytic or autoimmune
 disease or thrombocytopenia