Status:
COMPLETED
Pharmacokinetic Properties of Lorcaserin in Obese or Overweight Elderly Subjects
Lead Sponsor:
Eisai Inc.
Conditions:
Obesity
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the PK properties of lorcaserin in obese or overweight elderly subjects.
Eligibility Criteria
Inclusion
- Males or females
- Control (Adult) group: aged between 18 and 65 years (inclusive)
- Elderly group: aged \> 65 years (includes subjects 1 day or more beyond the 65th birthday)
- Able to give signed informed consent
- BMI 27-45 kg/m2, inclusive 6. Eligible male and female subjects must agree not to participate in a conception process (i.e. active attempt to become pregnant or to impregnate, egg or sperm donation, in vitro fertilization).
- 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), cerebral vascular accident (CVA), transient ischemic attack (TIA) or reversible ischemic neurologic deficit (RIND) within 6 months of screening
- Cardiac arrhythmia requiring initiation of new medical or surgical treatment within 6 months of screening (stable medical therapy for \> 6 months, pacemakers and/or defibrillators implanted \> 6 months prior to screening are acceptable)
- Unstable angina
- History of pulmonary artery hypertension
- Positive result of HIV, hepatitis B or hepatitis C screens
- Initiation of a new prescription medication within 1 month prior to screening with the following exceptions:
- Use of SSRIs, SNRIs, and other medications must meet washout period.
- Participated in any clinical study with an investigational drug, biologic, or device within 1 month prior to screening
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00828581
Start Date
October 1 2008
End Date
December 1 2008
Last Update
June 18 2023
Active Locations (1)
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1
CRI Worldwide - Lourdes Hospital
Willingboro, New Jersey, United States, 08046