Status:
COMPLETED
Pharmacokinetic Properties of Lorcaserin in the Fed and Fasted State
Lead Sponsor:
Eisai Inc.
Conditions:
Obesity
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the PK properties in fed and fasted men and women.
Eligibility Criteria
Inclusion
- Males or females aged between 18 and 65 years (inclusive)
- Able to give signed informed consent
- BMI 27-45 kg/m2, inclusive
- Eligible male and female subjects must agree not to participate in a conception process.
- Considered to be in stable health in the opinion of the Investigator.
Exclusion
- Prior participation in any study of lorcaserin.
- Clinically significant new illness in the 1 month before screening
- Not suitable to participate in the study in the opinion of the Investigator including an existing physical or mental condition that prevents compliance with the protocol
- History of any of the following cardiovascular conditions:
- Myocardial infarction (diagnosed by cardiac enzyme\[s\] and/or diagnostic ECG), CVA, TIA or RIND within 6 months of screening;
- Cardiac arrhythmia requiring medical or surgical treatment within 6 months of screening
- Unstable angina
- History of pulmonary artery hypertension
- Positive result of HIV, hepatitis B or hepatitis C screens
- Malignancy within 2 years of the screening visit (except basal cell or squamous cell carcinoma with clean surgical margins)
- Initiation of a new prescription medication within 1 month prior to screening.
- Recent history (within 2 years prior to the screening visit) of alcohol or drug/solvent abuse or a positive screen for drugs of abuse at screening.
- Participated in any clinical study with an investigational drug, biologic, or device within 1 month prior to screening
- Use of SSRIs,SNRIs, and other medications must meet the washout period.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00828724
Start Date
November 1 2008
End Date
December 1 2008
Last Update
September 12 2019
Active Locations (1)
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1
CRI Worldwide
Willingboro, New Jersey, United States, 08046