A study to evaluate the safety of a single dose of increasing amounts of PF0713 given via a vein to healthy adult male volunteers

Phase 1

Completed

• Conditions: Anaesthesia; Anaesthesiology - Anaesthetics

• Registration Number: ACTRN12608000602325
• Lead Sponsor: PharmacoFore, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-12-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 39

Inclusion Criteria

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 Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety: Adverse events (e.g., slow or rapid heart rate, low or high blood pressure, or apnea will be assessed by repeated observation), clinical laboratory data, blood gases, vital signs, electrocardiogram (ECG), ventilation status, physical exam[Screening visit, treatment visit, end-of-study visit five days after treatment];Tolerability: pain on injection, Quality of Recovery[Treatment visit];Pharmacodynamics: Richmond Agitation Sedation Score, Bispectral Index[Treatment visit]

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics[Blood will be sampled pre-dose, and 0.5, 1, 1.5, 2, 4, 8, 12, 15, 30, 60, 90 minutes, and 2, 4, 8, 24 hours post-dose. Urine will be sampled 30 minutes pre-dose and from the following intervals post dose: 0-6 hours, 6-12 hours, 12-24 hours]