A double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability and pharmacokinetic properties of TV-1380 in healthy volunteers.
Completed
- Conditions
- Cocaineverslaving en cocaine-overdosis.Cocaine addiction.
- Registration Number
- NL-OMON34473
- Lead Sponsor
- TEVA Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 56
Inclusion Criteria
Healthy males, 18 - 45 years, BMI 18 and 30 kg/m2; weight is at least 50 kg; no smokers for at least 3 months.
Exclusion Criteria
Suffering from: hepatitis B, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 90 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Pharmacodynamics : ex-vivo cocain hydrolysis<br /><br>Pharmacokinetics : serum TV-1380 concentrations, pharmacokinetic parameters<br /><br>Safety : adverse events, vital signs, ECG-parameters,<br /><br>local tolerability, laboratory parameters, physical examination<br /><br>Additional evaluations are: antibody levels to<br /><br>HSA, TV-1380 and hBChE, and BChE/AChE activity</p><br>
- Secondary Outcome Measures
Name Time Method <p>n.v.t.</p><br>