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.

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. - Trial to investigate safety and tolerability of neosaxitoxin

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46410

Enrollment

111

Registered

2017-12-06

Start date

2016-11-07

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

plexus-brachialisblokkade Brachial plexus blockade

Interventions

Part A Part A of the study will be performed in 8 groups each consisting of 5 healthy male volunteers. Two additional groups of 5 healthy male volunteers each may be added to the study based on the

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Evaluate the systemic and local safety and tolerability of ascending doses of Neosaxitoxin (NeoSTX) alone and in combination with fixed doses of bupivacaine (BUPI) (with and without epinephrine (EPI)), following brachial plexus blockade in healthy male subjects.	—

Secondary

Measure	Time frame
Evaluate the pharmacodynamics of ascending doses of Neosaxitoxin, alone and in combination with fixed doses of bupivacaine (with and without epinephrine), following brachial plexus blockade. Characterize the pharmacokinetics of Neosaxitoxin and bupivacaine after brachial plexus blockade with Neosaxitoxin alone or different drug combinations: Neosaxitoxin+epinephrine, Neosaxitoxin+bupivacaine, or Neosaxitoxin+bupivacaine+epinephrine.	—

Measure

Time frame

Evaluate the pharmacodynamics of ascending doses of Neosaxitoxin, alone and in combination with fixed doses of bupivacaine (with and without epinephrine), following brachial plexus blockade. Characterize the pharmacokinetics of Neosaxitoxin and bupivacaine after brachial plexus blockade with Neosaxitoxin alone or different drug combinations: Neosaxitoxin+epinephrine, Neosaxitoxin+bupivacaine, or Neosaxitoxin+bupivacaine+epinephrine.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)