Conditions: Healthy
Keywords: Endotoxin challenge
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 23
Healthy volunteers: yes

Brief summary:
An endotoxin challenge will be administered to healthy subjects to induce production of inflammatory markers. An investigational drug or placebo will be administered prior to the endotoxin challenge to assess the effect of the investigational drug on the markers of inflammation. Safety and tolerability will also be assessed.

Detailed description:
The trial was terminated on 25 March 2015 due to safety concerns regarding the administration of endotoxin and because of the uncertain availability of future endotoxin lots.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: PF-06282999 intervention 2: Placebo intervention 3: LPS intervention 4: PF-06282999 intervention 5: Placebo intervention 6: LPS
Intervention descriptions: intervention 1: Tablet, 125 mg, TID, 3 days, 1 of 2 periods intervention 2: Tablet, 0 mg, TID, 3 days, 1 of 2 periods intervention 3: IV bolus, 4 ng/kg, 1 day, QD, 2 of 2 periods intervention 4: Tablet, 500 mg, BID, 3 days, 1 of 2 periods intervention 5: Tablet, 0 mg, BID, 3 days, 1 of 2 periods intervention 6: IV bolus, 4 ng/kg, 1 day, QD, 2 of 2 periods

Protocol document: