Pharmacokinetic Properties of Lorcaserin in Obese or Overweight Elderly Subjects

NCT00828581 | Completed Phase 1

• 1 other identifier: APD356-018
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity

Outcome Measures

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.

Study Arms (1)

Lorcaserin

EXPERIMENTAL

Drug: lorcaserin

Interventions

lorcaserin DRUG

Lorcaserin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (1)

CRI Worldwide - Lourdes Hospital

Willingboro, New Jersey, 08046, United States

Location

Related Publications (1)

• Christopher RJ, Morgan ME, Tang Y, Anderson C, Sanchez M, Shanahan W. Pharmacokinetics and Tolerability of Lorcaserin in Special Populations: Elderly Patients and Patients with Renal or Hepatic Impairment. Clin Ther. 2017 Apr;39(4):837-848.e7. doi: 10.1016/j.clinthera.2017.03.004. Epub 2017 Mar 30.

  PMID: 28365033 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

lorcaserin

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2009
• First Posted: January 26, 2009
• Study Start: October 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: June 18, 2023

Record last verified: 2009-01

Locations

US (1)