Pharmacokinetic Properties of Lorcaserin in Obese or Overweight Elderly Subjects

Sponsor

Eisai Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00828581

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Obesity	Drug: lorcaserin	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Study Start Date :

Oct 1, 2008

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lorcaserin	Drug: lorcaserin

Arm

Intervention/Treatment

Experimental: Lorcaserin

Drug: lorcaserin

Outcome Measures

Primary Outcome Measures

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

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CRI Worldwide - Lourdes Hospital	Willingboro	New Jersey	United States	08046

Sponsors and Collaborators

Eisai Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eisai Inc.

ClinicalTrials.gov Identifier:

NCT00828581

Other Study ID Numbers:

APD356-018

First Posted:

Jan 26, 2009

Last Update Posted:

Sep 12, 2019

Last Verified:

Jan 1, 2009

Additional relevant MeSH terms:

Overweight

Study Results

No Results Posted as of Sep 12, 2019