Pharmacokinetic Properties of Lorcaserin in the Fed and Fasted State

NCT ID: NCT00828724

Last Updated: 2019-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2008-12-31

Brief Summary

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

Conditions

Obesity

Study Design

• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Lorcaserin 10mg

Group Type: EXPERIMENTAL

Lorcaserin 10mg

Intervention Type: DRUG

Interventions

Lorcaserin 10mg

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eisai Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CRI Worldwide

Willingboro, New Jersey, United States

Countries

United States

Other Identifiers

APD356-015

Identifier Type: -

Identifier Source: org_study_id