- To assess the safety and tolerability of single ascending intravenous (IV) bolus doses of the research medication- To determine the maximum tolerated dose (MTD) Intravenous of the research medication- To characterize the pharmacokinetics (PK) of…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
anesthesia
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety, PK and PD
Secondary outcome
Not applicable.
Background summary
The research medication is an IV anesthetic drug being developed for monitored
anesthesia care (MAC) and/or general anesthesia in patients undergoing
diagnostic or therapeutic procedures.
Study objective
- To assess the safety and tolerability of single ascending intravenous (IV)
bolus doses of the research medication
- To determine the maximum tolerated dose (MTD) Intravenous of the research
medication
- To characterize the pharmacokinetics (PK) of the research medication and its
primary metabolite.
- To assess the pharmacodynamics (PD) of the research medication
- To investigate the dose-response and PK/PD relationships.
Study design
This study will be a double-blind, randomized, placebo controlled, single
ascending dose study. Ten (10) cohorts of 6 subjects (5 active and 1 placebo)
are planned for evaluation and will be administered the research medication or
placebo as an IV bolus dose.
Intervention
The study will start with a screening. At the screening a physical examination
will take place and a few other standard medical assessments will be performed
(ECG, vital signs). Furthermore a blood and urine sample will be taken for
laboratory tests and an alcohol breath test and drug screen will be done.
During the stay in the clinic the subject will receive the research medication
once on Day 1. Safety will be monitored and sedation/anesthesia will be
assessed throughout the study. Arterial and venous serial blood samples will be
collected. The subjects will be asked for possible side effects on regular
basis.
Finally, a follow-up visit will take place.
Study burden and risks
The dose levels for this study have been selected on the basis of research
results in animals.
Based on these studies the following side effects may be experienced in humans:
- Inflammation, discoloration and/or redness at the injection site
- Decreased brain activity consistent with sedation/anesthesia
- Decreases in average blood pressure, heart rate, and pulse pressure
- A prolongation of the QTc interval (QTc is one of the ECG measurements)
- Sedation (decreased consciousness) and anesthesia
- Decrease in oxygen in your blood
- Involuntary muscle movements (twitches and uncontrollable jerky movements)
All drugs have a potential risk of causing an allergic reaction, which if not
treated promptly, could become life threatening. The subjects will be monitored
for any allergic reactions and emergency treatment will be provided as needed.
The blood collection procedure is not dangerous, but may cause discomfort or
bruising.
Occasionally, fainting or an infection at the blood sampling site can occur.
Shaving may be required for proper placement of ECG patches. This may cause
irritation or bleeding of the skin. ECG patches may cause redness, itching,
rash or blisters on the skin and/or hair loss due to removal of ECG patches.
First Street, Suite 303 25
Cambridge 02140
US
First Street, Suite 303 25
Cambridge 02140
US
Listed location countries
Age
Inclusion criteria
Healthy men and/or women between 18 and 45 years of age (inclusive)
Exclusion criteria
Clinical significant abnormalities at medical research
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2013-005359-33-NL |
| CCMO | NL48312.056.14 |