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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
History of Changes
  Purpose

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: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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:

MedlinePlus related topics: Obesity
Drug Information available for: Lorcaserin
U.S. FDA Resources

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 [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00828724

Locations
United States, New Jersey
CRI Worldwide
Willingboro, New Jersey, United States, 08046
Sponsors and Collaborators
Arena Pharmaceuticals
Investigators
Investigator: Christen Anderson, MD, PhD Arena Pharmaceuticals
  More Information

No publications provided

Responsible Party: Christen Anderson, MD, PhD, Arena Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00828724     History of Changes
Other Study ID Numbers: APD356-015
Study First Received: January 22, 2009
Last Updated: January 23, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013