Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000602325
Ethics application status
Approved
Date submitted
19/11/2008
Date registered
3/12/2008
Date last updated
4/07/2012
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
Anaesthetics

Intervention/exposure
Study type
Interventional
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
Uncontrolled

Outcomes
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
Pharmacokinetics
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

Eligibility
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
Sex
Males
Can healthy volunteers participate?
Yes
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
Treatment
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
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/12/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
39
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4180 0
Commercial sector/Industry
Name [1] 4180 0
PharmacoFore, Inc.
Country [1] 4180 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
PharmacoFore, Inc.
Address
75 Shoreway Road, Suite D
San Carlos, CA 94070
Country
United States of America
Secondary sponsor category [1] 3753 0
None
Name [1] 3753 0
Address [1] 3753 0
Country [1] 3753 0

Ethics approval
Ethics application status
Approved
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
27/10/2008
Approval date [1] 6235 0
Ethics approval number [1] 6235 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
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
[email protected]
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
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.