Pharmacokinetic Properties of Lorcaserin in the Fed and Fasted State

Eisai

Status and phase: Completed; Phase 1

Conditions: Obesity

Treatments: Drug: Lorcaserin 10mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00828724

APD356-015

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

24 participants in 1 patient group

Lorcaserin 10mg

Experimental group

Treatment:

Drug: Lorcaserin 10mg