An exploratory Phase I randomized, single-site, double-blind, active-controlled, parallel-group, single-administration, dose-escalation trial to investigate the safety and tolerability of neosaxitoxin alone and in combination with bupivacaine (with and without epinephrine), in perineural administrations for brachial plexus blockade in healthy subjects.
Completed
- Conditions
- plexus-brachialisblokkadeBrachial plexus blockade
- Registration Number
- NL-OMON46410
- Lead Sponsor
- Grünenthal GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 111
Inclusion Criteria
- Male subject, aged 18 years to 55 years, inclusive.;- Body mass index between 20.0 kg/m2 and 30.0 kg/m2 inclusive, with a minimal body weight of 60.0 kg.;- Subject must be in good health as determined by the prior/concomitant diseases, physical and laboratory examinations.;- Non-smoking or not more than 10 sigarettes, 2 cigars or 2 pipes per day
Exclusion Criteria
Suffering from hepatitis B, hepatitis C, or HIV/AIDS. In case of participating in another drug study withing 1 month prior to the screening visit, donated 100 mL or more of blood between the screening visit and entry into the PRA research center excluding blood taken for this clinical study, donated 500 mL or more of blood within 3 months prior to the screening viist.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Evaluate the systemic and local safety and tolerability of ascending doses of<br /><br>Neosaxitoxin (NeoSTX) alone and in combination with fixed doses of bupivacaine<br /><br>(BUPI) (with and without epinephrine (EPI)), following brachial plexus blockade<br /><br>in healthy male subjects.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Evaluate the pharmacodynamics of ascending doses of Neosaxitoxin, alone and in<br /><br>combination with fixed doses of bupivacaine (with and without epinephrine),<br /><br>following brachial plexus blockade.<br /><br><br /><br>Characterize the pharmacokinetics of Neosaxitoxin and bupivacaine after<br /><br>brachial plexus blockade with Neosaxitoxin alone or different drug<br /><br>combinations: Neosaxitoxin+epinephrine, Neosaxitoxin+bupivacaine, or<br /><br>Neosaxitoxin+bupivacaine+epinephrine.</p><br>