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

Mise à jour : Il y a 4 ans
Référence : EUCTR2007-000280-17

Femme et Homme

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Extrait

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.


Critère d'inclusion

  • Traumatic Brain Injury (TBI)