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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Drug: Lorcaserin 10mg

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Willingboro, New Jersey, United States, 08046
      • CRI Worldwide

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lorcaserin 10mg	Drug: Lorcaserin 10mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To evaluate the pharmacokinetic properties of a single oral dose of lorcaserin in the fed versus fasted state

Collaborators and Investigators

• Sponsor: Eisai Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: January 22, 2009
• First Submitted That Met QC Criteria: January 23, 2009
• First Posted (Estimate): January 26, 2009

Study Record Updates

• Last Update Posted (Actual): September 12, 2019
• Last Update Submitted That Met QC Criteria: September 11, 2019
• Last Verified: January 1, 2009

More Information

Terms related to this study

• Other Study ID Numbers: APD356-015