A DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, ESCALATING MULTIPLE-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TV-1380 IN HEALTHY VOLUNTEERS

A DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, ESCALATING MULTIPLE-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TV-1380 IN HEALTHY VOLUNTEERS - TV-1380 MAD study in healthy volunteers

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35366

Enrollment

Registered

2011-11-08

Start date

2011-11-28

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 Treatm

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy male and female volunteers, 18-45 years of age, BMI between 18.0 and 30.0 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
Pharmacokinetics: Serum TV-1380 concentrations, pharmacokinetics parameters Safety: Adverse events, vital signs, ECG-parameters, local tolerability, laboratory parameters, physical examination Additional evaluations are: BChE and AChE activity, immunogenicity and ex vivo hydrolysis	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)