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Pharmacokinetic Properties of Lorcaserin in the Fed and Fasted State

This study has been completed.
Sponsor:
Information provided by:
Arena Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00828724
First received: January 22, 2009
Last updated: January 23, 2009
Last verified: January 2009

January 22, 2009
January 23, 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 [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00828724 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Obesity
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
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.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00828724
APD356-015
No
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