A double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability and pharmacokinetic properties of TV-1380 in healthy volunteers.

A double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability and pharmacokinetic properties of TV-1380 in healthy volunteers. - TV-1380 single rising dose study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34473

Enrollment

Registered

2010-07-22

Start date

2010-08-27

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

Cocaineverslaving en cocaine-overdosis. Cocaine addiction.

Interventions

Active substance : TV-1380 Activity : cocaine hydrolysis Indication : cocaine addiction Strength : 30 mg vial with 1.1 ml sterile water for injection Dosage form : intramuscular injection Treatments

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Pharmacodynamics : ex-vivo cocain hydrolysis Pharmacokinetics : serum TV-1380 concentrations, pharmacokinetic parameters Safety : adverse events, vital signs, ECG-parameters, local tolerability, laboratory parameters, physical examination Additional evaluations are: antibody levels to HSA, TV-1380 and hBChE, and BChE/AChE activity	—

Secondary

Measure	Time frame
n.v.t.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)