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Pharmacokinetic Properties of Lorcaserin in the Fed and Fasted State

This study has been completed.
Information provided by:
Arena Pharmaceuticals Identifier:
First received: January 22, 2009
Last updated: January 23, 2009
Last verified: January 2009
The purpose of this study is to evaluate the PK properties in fed and fasted men and women.

Condition Intervention Phase
Obesity Drug: Lorcaserin 10mg Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Arena Pharmaceuticals:

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

Enrollment: 24
Study Start Date: November 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lorcaserin 10mg Drug: Lorcaserin 10mg


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.
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

Responsible Party: Christen Anderson, MD, PhD, Arena Pharmaceuticals, Inc. Identifier: NCT00828724     History of Changes
Other Study ID Numbers: APD356-015
Study First Received: January 22, 2009
Last Updated: January 23, 2009 processed this record on September 21, 2017