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OpenTrials
Completed

NCT Number: NCT00828724

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CRI Worldwide

Willingboro, New Jersey, 08046, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males or females aged between 18 and 65 years (inclusive)
  • Able to give signed informed consent
  • BMI 27-45 kg/m2, inclusive
  • Eligible male and female subjects must agree not to participate in a conception process.
  • Considered to be in stable health in the opinion of the Investigator.

Exclusion criteria

  • Prior participation in any study of lorcaserin.
  • Clinically significant new illness in the 1 month before screening
  • 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
  • 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
  • Positive result of HIV, hepatitis B or hepatitis C screens
  • Malignancy within 2 years of the screening visit (except basal cell or squamous cell carcinoma with clean surgical margins)
  • Initiation of a new prescription medication within 1 month prior to screening.
  • 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.
  • Participated in any clinical study with an investigational drug, biologic, or device within 1 month prior to screening
  • Use of SSRIs,SNRIs, and other medications must meet the washout period.

Treatment and study plan

Lorcaserin 10mg

Drug

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Eisai Inc.

Industry

Registry information

Official study title

An Open Label, Single Dose, Cross-over Study to Assess the Pharmacokinetic Properties of Lorcaserin in the Fed and Fasted State

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jan 26, 2009
Registry last updated
Sep 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.