A study to evaluate the safety of a single dose of increasing amounts of PF0713 given via a vein to healthy adult male volunteers
A Phase 1, Open Label, Single-Center, Dose-Escalation, Cohort Study to Determine the Safety, Pharmacodynamics and Pharmacokinetics of a Single Intravenous (IV) Injection of PF0713 in Healthy Subjects
PharmacoFore, Inc.
39 participants
Dec 4, 2008
Interventional
Conditions
Summary
The purpose of this study is to test the safety and the effect on the body of a drug called PF0713. PF0713 is being developed for commencement and maintenance of anaesthesia and sedation. The hypothesis is that PF0713 will produce anaesthetic effects and be well tolerated.
Eligibility
Inclusion Criteria1
- Body mass index between 18 and 30 kg/m^2, blood pressure between 100-140/60-90 mmHg, heart rate between 50-99 beats per minute
Exclusion Criteria1
- Problems with anesthesia, allergy or sensitivity to propofol or components of the formulation, regular tobacco use, alcohol or drug abuse in the past 2 years, enrollment in an investigational drug study within 30 days, American Society of Anesthesiologists Physical Status Classification greater than II.
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Interventions
A single dose of PF0713 will be administered intravenously to each volunteer. The initial dose will be 0.0156 mg/kg. Doses will be increased by multiples of two. The maximum dose will be determined based upon observed responses (e.g., anesthesia for more than 10 minutes).
Locations(1)
View Full Details on ANZCTR
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ACTRN12608000602325