Trials / Terminated
TerminatedNCT03399435
A Study in Healthy Male Volunteers to Investigate the Safety and Tolerability of a Single Dose of Neosaxitoxin Alone and in Combination With Bupivacaine (With and Without Epinephrine) for Brachial Plexus Blockade
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
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 242 (actual)
- Sponsor
- Grünenthal GmbH · Industry
- Sex
- Male
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
Neosaxitoxin is a new compound that is in clinical development as local anesthetic for surgical anesthesia and postoperative analgesia. The primary objective of this study is to evaluate the systemic and local safety and tolerability of ascending doses of neosaxitoxin alone and in combination with fixed doses of bupivacaine (with and without epinephrine), following brachial plexus blockade in healthy male subjects. Secondary objectives: * Evaluate the pharmacodynamics (PD) 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 (PK) of neosaxitoxin and bupivacaine after brachial plexus blockade with neosaxitoxin alone or different drug combinations: neosaxitoxin and epinephrine, neosaxitoxin and bupivacaine, or neosaxitoxin and bupivacaine and epinephrine.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | Neosaxitoxin combined with bupivacaine low and epinephrine (T1) | A single injection: Neosaxitoxin from 1.25 to 60 µg. Bupivacaine 40 mg. Epinephrine 100 µg. |
| COMBINATION_PRODUCT | Bupivacaine low combined with epinephrine (C1) | A single injection: Bupivacaine 40 mg. Epinephrine dose 100 µg. |
| COMBINATION_PRODUCT | Bupivacaine high combined with epinephrine (C2) | A single injection: Bupivacaine 100 mg. Epinephrine 100 µg. |
| COMBINATION_PRODUCT | Neosaxitoxin combined with bupivacaine low (T2) | A single injection: Neosaxitoxin from 1.25 to 60 μg. Bupivacaine from 10 to 80 mg. |
| DRUG | Bupivacaine low (C3) | A single injection: Bupivacaine from 10 to 80 mg. |
| DRUG | Bupivacaine high (C4) | A single injection: Bupivacaine 100 mg. |
| DRUG | Neosaxitoxin (T3) | A single injection: Neosaxitoxin will be between 1.25 and 60 µg. |
| COMBINATION_PRODUCT | Neosaxitoxin combined with epinephrine (T4) | A single injection: Neosaxitoxin will be between 1.25 and 60 μg. Epinephrine 100 µg. |
| COMBINATION_PRODUCT | Neosaxitoxin combined with bupivacaine low and epinephrine | A single injection: Neosaxitoxin will be between 1.25 to 60 µg. Bupivacaine dose based on results from Part B (10 to 80 mg). Epinephrine 100 µg. |
| COMBINATION_PRODUCT | Neosaxitoxin combined with bupivacaine low | A single injection: Neosaxitoxin will be between 1.25 to 60 μg. Bupivacaine dose based on results from Part B (10 to 80 mg). |
Timeline
- Start date
- 2018-01-30
- Primary completion
- 2018-09-21
- Completion
- 2018-09-21
- First posted
- 2018-01-16
- Last updated
- 2018-10-11
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT03399435. Inclusion in this directory is not an endorsement.