CompletedPhase 1ACTRN12608000602325

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


Sponsor

PharmacoFore, Inc.

Enrollment

39 participants

Start Date

Dec 4, 2008

Study Type

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

Sex: MalesMin Age: 18 YearssMax Age: 50 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests the safety of a new anesthetic drug called PF0713 given through an IV at increasing doses in healthy adult men. Participants must be aged 18 to 50 with normal blood pressure and heart rate. People with allergies to propofol, tobacco users, or those with a history of drug or alcohol abuse cannot participate.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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)

Australia

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ACTRN12608000602325


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