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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
A study to evaluate the safety of a single dose of increasing amounts of PF0713 given via a vein to healthy adult male volunteers
Scientific title
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
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaesthesia 3990 0
Condition category
Condition code
Anaesthesiology 4189 4189 0 0

Study type
Description of intervention(s) / exposure
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).
Intervention code [1] 3715 0
Treatment: Drugs
Comparator / control treatment
There is no comparator or control treatment.
Control group

Primary outcome [1] 5079 0
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
Timepoint [1] 5079 0
Screening visit, treatment visit, end-of-study visit five days after treatment
Primary outcome [2] 5080 0
Tolerability: pain on injection, Quality of Recovery
Timepoint [2] 5080 0
Treatment visit
Primary outcome [3] 5081 0
Pharmacodynamics: Richmond Agitation Sedation Score, Bispectral Index
Timepoint [3] 5081 0
Treatment visit
Secondary outcome [1] 8532 0
Timepoint [1] 8532 0
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

Key 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
Minimum age
18 Years
Maximum age
50 Years
Can healthy volunteers participate?
Key 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
Purpose of the study
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Single group
Other design features
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4180 0
Commercial sector/Industry
Name [1] 4180 0
PharmacoFore, Inc.
Address [1] 4180 0
75 Shoreway Road, Suite D
San Carlos, CA 94070
Country [1] 4180 0
United States of America
Primary sponsor type
Commercial sector/Industry
PharmacoFore, Inc.
75 Shoreway Road, Suite D
San Carlos, CA 94070
United States of America
Secondary sponsor category [1] 3753 0
Name [1] 3753 0
Address [1] 3753 0
Country [1] 3753 0

Ethics approval
Ethics application status
Ethics committee name [1] 6235 0
Ethics committee address [1] 6235 0
Ethics committee country [1] 6235 0
Date submitted for ethics approval [1] 6235 0
Approval date [1] 6235 0
Ethics approval number [1] 6235 0

Brief 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.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 29139 0
Address 29139 0
Country 29139 0
Phone 29139 0
Fax 29139 0
Email 29139 0
Contact person for public queries
Name 12296 0
Lawrence Siegel
Address 12296 0
PharmacoFore, Inc.
75 Shoreway Road, Suite D
San Carlos, CA 94070
Country 12296 0
United States of America
Phone 12296 0
1-650-331-4000, ext 4015
Fax 12296 0
Email 12296 0
Contact person for scientific queries
Name 3224 0
Lawrence Siegel
Address 3224 0
PharmacoFore, Inc.
75 Shoreway Road, Suite D
San Carlos, CA 94070
Country 3224 0
United States of America
Phone 3224 0
1-650-331-4000, ext 4015
Fax 3224 0
Email 3224 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary