Pharmacokinetic Properties of Lorcaserin in the Fed and Fasted State

NCT00828724 | Completed Phase 1

• 1 other identifier: APD356-015
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the PK properties in fed and fasted men and women.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

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

Study Arms (1)

Lorcaserin 10mg

EXPERIMENTAL

Drug: Lorcaserin 10mg

Interventions

Lorcaserin 10mg DRUG

Lorcaserin 10mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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), 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.

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (1)

CRI Worldwide

Willingboro, New Jersey, 08046, United States

Location

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
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2009
• First Posted: January 26, 2009
• Study Start: November 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: September 12, 2019

Record last verified: 2009-01

Locations

US (1)