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

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

Condition or disease Intervention/treatment Phase
Obesity Drug: Lorcaserin 10mg Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: An Open Label, Single Dose, Cross-Over Study to Assess the Pharmacokinetic Properties of Lorcaserin in the Fed and Fasted State
Study Start Date : November 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Lorcaserin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Lorcaserin 10mg Drug: Lorcaserin 10mg

Primary Outcome Measures :
  1. To evaluate the pharmacokinetic properties of a single oral dose of lorcaserin in the fed versus fasted state

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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)
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00828724

United States, New Jersey
CRI Worldwide
Willingboro, New Jersey, United States, 08046
Sponsors and Collaborators
Arena Pharmaceuticals
OverallOfficial: Christen Anderson, MD, PhD Arena Pharmaceuticals

Responsible Party: Christen Anderson, MD, PhD, Arena Pharmaceuticals, Inc. Identifier: NCT00828724     History of Changes
Other Study ID Numbers: APD356-015
First Posted: January 26, 2009    Key Record Dates
Last Update Posted: January 26, 2009
Last Verified: January 2009