Status:
TERMINATED
An Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics Study of JNJ-17299425 in Participants With Traumatic Brain Injury
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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 bod...
Detailed Description
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 (injecti...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01814982
Start Date
August 1 2007
End Date
August 1 2008
Last Update
May 1 2013
Active Locations (11)
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1
Aalst, Belgium
2
Brussels, Belgium
3
Edegem, Belgium
4
Genk, Belgium