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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00828724

Enrollment

Registered

2009-01-26

Start date

2008-11-30

Completion date

2008-12-31

Last updated

2019-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Brief summary

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

Interventions

DRUGLorcaserin 10mg

Study design

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026