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Completed

NCT Number: NCT00828581

Pharmacokinetic Properties of Lorcaserin in Obese or Overweight Elderly Subjects

The purpose of this study is to evaluate the PK properties of lorcaserin in obese or overweight elderly subjects.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CRI Worldwide - Lourdes Hospital

Willingboro, New Jersey, 08046, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Males or females
  • Control (Adult) group: aged between 18 and 65 years (inclusive)
  • Elderly group: aged > 65 years (includes subjects 1 day or more beyond the 65th birthday)
  • Able to give signed informed consent
  • BMI 27-45 kg/m2, inclusive 6. Eligible male and female subjects must agree not to participate in a conception process (i.e. active attempt to become pregnant or to impregnate, egg or sperm donation, in vitro fertilization).
  • 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), cerebral vascular accident (CVA), transient ischemic attack (TIA) or reversible ischemic neurologic deficit (RIND) within 6 months of screening
  • Cardiac arrhythmia requiring initiation of new medical or surgical treatment within 6 months of screening (stable medical therapy for > 6 months, pacemakers and/or defibrillators implanted > 6 months prior to screening are acceptable)
  • Unstable angina
  • History of pulmonary artery hypertension
  • Positive result of HIV, hepatitis B or hepatitis C screens
  • Initiation of a new prescription medication within 1 month prior to screening with the following exceptions:
  • Use of SSRIs, SNRIs, and other medications must meet washout period.
  • Participated in any clinical study with an investigational drug, biologic, or device within 1 month prior to screening

Treatment and study plan

Lorcaserin

Drug

Primary outcomes

  1. To compare the single-dose pharmacokinetic (PK) parameters of lorcaserin in the obese or overweight Elderly (> 65) to those obtained from the obese or overweight Adult (18-65)

Secondary outcomes

  1. To assess the safety and tolerability of a single oral dose of lorcaserin in obese or overweight Elderly (> 65) subjects and obese or overweight Adult (18-65) subjects.

Sponsors and collaborators

Lead sponsor

Eisai Inc.

Industry

Registry information

Official study title

An Open-Label, Single-Dose Study of the Pharmacokinetic Properties of Lorcaserin in Obese or Overweight Elderly Subjects

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jan 26, 2009
Registry last updated
Jun 18, 2023

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.

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