Pharmacokinetic Properties of Lorcaserin in Subjects With Hepatic Impairment - Full Text View

Sponsored by:	Arena Pharmaceuticals
Information provided by:	Arena Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00828932

Purpose

The purpose of this study is to evaluate and establish whether lorcaserin dose adjustment is required in patients with mild or moderate hepatic impairment.

Condition	Intervention	Phase
Hepatic Impairment	Drug: Lorcaserin	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Open Label, Single Group Assignment, Pharmacokinetics Study
Official Title:	An Open Label, Single Dose Study of the Pharmacokinetic Properties of Lorcaserin in Subjects With Hepatic Impairment

Further study details as provided by Arena Pharmaceuticals:

Primary Outcome Measures:

The primary objective of this study is to evaluate the pharmacokinetic properties of lorcaserin in subjects with mild or moderate hepatic impairment compared to subjects with normal hepatic function. [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the safety and tolerability of lorcaserin [ Designated as safety issue: Yes ]

Estimated Enrollment:	24
Study Start Date:	September 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Lorcaserin 10mg: Experimental	Drug: Lorcaserin

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Males or females aged between 18 and 75 years (inclusive)
Able to give signed informed consent
Hepatic function will fall into one of the following categories:
- One-third of patients will have normal hepatic function (defined as having all of the following parameters within the normal range of the clinical laboratory used for this trial: AST, ALT, alkaline phosphatase, total bilirubin)
- One-third of patients will have mild impairment (Child-Pugh score 5-6)
- One-third of patients will have moderate impairment (Child-Pugh score 7-9)
All subjects will have a BMI of 27-45 kg/m2, inclusive.
Eligible male and female patients must agree not to participate in a conception process
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), CVA, TIA or 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
Surgically implanted portacaval shunts are excluded with the following exception: transjugular intrahepatic portosystemic shunts (TIPS) will be allowed if placed no less than 3 months prior to dosing
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 3 months prior to the screening visit) of alcohol or drug/solvent abuse or a positive screen for drugs of abuse at screening.
Use of SSRI's, SNRI's, and other medications must meet the required washout periods.
Participated in any clinical study with an investigational drug, biologic, or device within 1 month prior to dosing

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00828932

Locations

United States, Florida
Orlando Clinical Research Center
Orlando, Florida, United States, 32809

Sponsors and Collaborators

Arena Pharmaceuticals

Investigators

Investigator:

Christen Anderson, MD, PhD

Arena Pharmaceuticals

More Information

No publications provided

Responsible Party:	Arena Pharmaceuticals, INc. ( Christen Anderson, MD, PhD )
Study ID Numbers:	APD356-017
Study First Received:	January 22, 2009
Last Updated:	January 23, 2009
ClinicalTrials.gov Identifier:	NCT00828932 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Liver Diseases
Digestive System Diseases

Additional relevant MeSH terms:

Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 07, 2009