To evaluate the safety, tolerability and pharmacokinetics of TV-1380 after single escalating doses in healthy male volunteers.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Cocaineverslaving en cocaine-overdosis.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
n.v.t.
Background summary
The drug to be given, TV-1380, is a new, investigational compound that may
eventually be used for the treatment of cocaine addiction or cocaine overdose.
TV-1380 is still in the developmental phase. If there is cocaine in the body
systems, the compound rapidly eliminates it from the brain, heart and periphery
by facilitating the degradation of cocaine. In the absence of cocaine the drug
is not expected to have any pharmacological effect. The volunteers will be
getting only the drug, no cocaine will be administered.
This new compound is not registered as a drug. This is the first time that this
compound is being given to humans.
Study objective
To evaluate the safety, tolerability and pharmacokinetics of TV-1380 after
single escalating doses in healthy male volunteers.
Study design
This is a randomized, double-blind, placebo-controlled, single-ascending dose
study. Fifty six (56) healthy male subjects will be allocated to seven groups
of eight healthy male subjects each. Within each group, 6 subjects will receive
a single intramuscular injection of TV-1380 and 2 subjects will receive
placebo. At the highest dose 2 intramuscular injections will be given. In the
first group two subjects (one verum and one placebo) will be dosed 72 hours
prior to the remaining six subjects (five verum and one placebo). In the other
groups (2-7) the first 2 subjects (one verum and one placebo) will be dosed
minimum 2 hours before the remaining 6 subjects (five verum and one placebo).
Intervention
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
Cohort 1: a single intramuscular injection of 0.5 mg TV-1380 or placebo on Day 1
Cohort 2: a single intramuscular injection of 1.5 mg TV-1380 or placebo on Day 1
Cohort 3: a single intramuscular injection of 5 mg TV-1380 or placebo on Day 1
Cohort 4: a single intramuscular injection of 15 mg TV-1380 or placebo on Day 1
Cohort 5: a single intramuscular injection of 50 mg TV-1380 or placebo on Day 1
Cohort 6: a single intramuscular injection of 150 mg TV-1380 or placebo on Day 1
Cohort 7: two intramuscular injections of in total 300 mg TV-1380 or placebo on
Day 1
Study burden and risks
Procedures: pain, light bleeding, aematoma, possibly an infection.
12 Hatrufa St PO Box 8077
Netanya
IL
12 Hatrufa St PO Box 8077
Netanya
IL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2010-021561-76-NL |
| CCMO | NL33121.056.10 |