Conditions: Fever
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 60
Healthy volunteers: yes

Brief summary:
A research study to determine if acetaminophen (APAP) given intravenously (IV-a liquid given through a needle into a vein in your arm) is safe and effective in controlling fever when compared to placebo. Acetaminophen given this way is the investigational part of this study.

Detailed description:
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Single-Dose Study of the Efficacy and Safety of Intravenous Acetaminophen (IVAPAP) Versus Placebo for the Treatment of Endotoxin-Induced Fever in Healthy Adult Males

Arms:
arm 1: 1 g of acetaminophen in 100 mL of intravenous solution arm 2: 100 mL of intravenous placebo solution

Interventions: intervention 1: IV Placebo intervention 2: IV Acetaminophen intervention 3: Reference Standard Endotoxin (RSE)
Intervention descriptions: intervention 1: IV Placebo intervention 2: Intravenous acetaminophen solution 1 g / 100 ml intervention 3: Administration of Reference Standard Endotoxin (RSE) to induce fever. Applicable to both study arms: Administration of a 1 ng/kg body weight test dose of RSE to test for fever response. Observation period of at least 60 minutes to ensure no exaggerated systemic responses, followed by administration of a 4 ng/kg of RSE to induce fever.

Protocol document: