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Pharmacokinetic Properties of Lorcaserin in the Fed and Fasted State

An Open Label, Single Dose, Cross-over Study to Assess the Pharmacokinetic Properties of Lorcaserin in the Fed and Fasted State

NCT00828724•Eisai Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the PK properties in fed and fasted men and women.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Males or females aged between 18 and 65 years (inclusive)
•2. Able to give signed informed consent
•3. BMI 27-45 kg/m2, inclusive
•4. Eligible male and female subjects must agree not to participate in a conception process.
•5. Considered to be in stable health in the opinion of the Investigator.

Exclusion Criteria

•1. Prior participation in any study of lorcaserin.
•2. Clinically significant new illness in the 1 month before screening
•3. 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
•4. 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
•5. Positive result of HIV, hepatitis B or hepatitis C screens
•6. Malignancy within 2 years of the screening visit (except basal cell or squamous cell carcinoma with clean surgical margins)
+4 more criteria

Locations (1)

CRI Worldwide

Willingboro, New Jersey, United States

Key Dates

Start Date

November 1, 2008

Primary Completion Date

December 1, 2008

Completion Date

December 1, 2008

Last Updated

September 12, 2019

Enrollment

ACTUAL participants

Conditions

Obesity

Interventions

Lorcaserin 10mg

DRUG

Multi-Acupoint Laser Therapy for Body Shape and Composition in Obese Menopausal Women

NCT07472881

MenopausePerimenopause+2 more

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RECRUITING

Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System

NCT01143454

Metabolic DiseaseObesity+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 12, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Pharmacokinetic Properties of Lorcaserin in the Fed and Fasted State

Inclusion Criteria

Exclusion Criteria

Multi-Acupoint Laser Therapy for Body Shape and Composition in Obese Menopausal Women

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