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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000602325

Enrollment

Registered

2008-12-03

Start date

2008-12-04

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

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).

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

Male

Age

18 Years to 50 Years

Healthy volunteers

Yes

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.

Outcome results