Pharmacokinetic Properties of Lorcaserin in Obese or Overweight Elderly Subjects

June 16, 2023 updated by: Eisai Inc.

An Open-Label, Single-Dose Study of the 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Willingboro, New Jersey, United States, 08046
        • CRI Worldwide - Lourdes Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Males or females
  2. Control (Adult) group: aged between 18 and 65 years (inclusive)
  3. Elderly group: aged > 65 years (includes subjects 1 day or more beyond the 65th birthday)
  4. Able to give signed informed consent
  5. 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).
  6. 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), 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
  5. Positive result of HIV, hepatitis B or hepatitis C screens
  6. Initiation of a new prescription medication within 1 month prior to screening with the following exceptions:
  7. Use of SSRIs, SNRIs, and other medications must meet washout period.
  8. Participated in any clinical study with an investigational drug, biologic, or device within 1 month prior to screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lorcaserin
Drug: lorcaserin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

January 22, 2009

First Submitted That Met QC Criteria

January 23, 2009

First Posted (Estimated)

January 26, 2009

Study Record Updates

Last Update Posted (Estimated)

June 19, 2023

Last Update Submitted That Met QC Criteria

June 16, 2023

Last Verified

January 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APD356-018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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