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Pharmacokinetic Properties of Lorcaserin in the Fed and Fasted State

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00828724
Recruitment Status : Completed
First Posted : January 26, 2009
Last Update Posted : January 26, 2009
Information provided by:
Arena Pharmaceuticals

January 22, 2009
January 26, 2009
January 26, 2009
November 2008
December 2008   (Final data collection date for primary outcome measure)
To evaluate the pharmacokinetic properties of a single oral dose of lorcaserin in the fed versus fasted state
Same as current
No Changes Posted
Not Provided
Not Provided
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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
The purpose of this study is to evaluate the PK properties in fed and fasted men and women.
Not Provided
Phase 1
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Drug: Lorcaserin 10mg
Experimental: Lorcaserin 10mg
Intervention: Drug: Lorcaserin 10mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2008
December 2008   (Final data collection date for primary outcome measure)

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)
  7. Initiation of a new prescription medication within 1 month prior to screening.
  8. 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.
  9. Participated in any clinical study with an investigational drug, biologic, or device within 1 month prior to screening
  10. Use of SSRIs,SNRIs, and other medications must meet the washout period.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Christen Anderson, MD, PhD, Arena Pharmaceuticals, Inc.
Arena Pharmaceuticals
Not Provided
Investigator: Christen Anderson, MD, PhD Arena Pharmaceuticals
Arena Pharmaceuticals
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP