Status:
COMPLETED
Abuse Potential of Single Doses of Lorcaserin in Healthy Recreational Polydrug Users
Lead Sponsor:
Eisai Inc.
Conditions:
Drug Abuse
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the abuse potential of lorcaserin in healthy recreational polydrug users.
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- Healthy male or female subjects 18 to 55 years of age, inclusive.
- Body mass index (BMI) within the range of 18 to 33 kg/m2, inclusive, and a minimum weight of at least 50 kg at Screening.
- Free from any clinically significant medical or psychiatric abnormality
- Recreational polydrug user with a history of psychedelic and depressant drug use,and at least one occasion of use in the past 3 months.
- Female subjects must have a negative serum pregnancy test at Screening and urine pregnancy test at each admission.
- Female subjects of childbearing potential must be practising abstinence or using and willing to continue using a medically acceptable form of birth control for at least 1 month after the last study drug administration. Male subjects who have female partners of childbearing potential must ensure that their partner use an acceptable method of contraception.
- Willingness to take a drug that might alter perception in a controlled setting.
- EXCLUSION CRITERIA
- A subject will not be considered eligible to participate in this study, if any one of the following exclusion criteria is satisfied:
- A history or presence of drug or alcohol dependence (excluding nicotine and caffeine).
- Use of non-prescription, prescription medication or natural health products (except acetaminophen, vitamin or mineral supplements, acceptable forms of birth control, and hormone replacement) within 7 days prior to first drug administration in the qualification phase and throughout the study.
- Use of SSRIs (e.g. fluoxetine, paroxetine, citalopram) within 14 days prior to first drug administration in the qualification phase and throughout the study.
- History of allergy or hypersensitivity to the study drugs
- Female subjects who are currently pregnant or lactating or who are planning to become pregnant within 30 days of last study drug administration
- Treatment with any investigational drug within 30 days prior to first drug administration during the qualification phase.
Exclusion
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2009
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00828659
Start Date
December 1 2008
End Date
April 1 2009
Last Update
September 12 2019
Active Locations (1)
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1
Kendle Early Phase, Toronto
Toronto, Ontario, Canada, M5V 2T3