Pharmacokinetic Properties of Lorcaserin in Subjects With Hepatic Impairment

• Sponsor: Eisai Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00828932
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arm: 1
• Duration (Months): 4
• Patients Per Site Per Month: 6

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Hepatic Impairment	Drug: Lorcaserin	Phase 1

Study Design

• Study Type: Interventional
• Anticipated 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 Subjects With Hepatic Impairment
• Study Start Date: Aug 1, 2008
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lorcaserin 10mg	Drug: Lorcaserin

Outcome Measures

Primary Outcome Measures

1. 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. []

Secondary Outcome Measures

1. To evaluate the safety and tolerability of lorcaserin []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Males or females aged between 18 and 75 years (inclusive)

2. Able to give signed informed consent

3. 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)

1. All subjects will have a BMI of 27-45 kg/m2, inclusive.

2. Eligible male and female patients must agree not to participate in a conception process

3. 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), 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

1. 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

2. Malignancy within 2 years of the screening visit (except basal cell or squamous cell carcinoma with clean surgical margins)

3. Initiation of a new prescription medication within 1 month prior to screening.

4. 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.

5. Use of SSRI's, SNRI's, and other medications must meet the required washout periods.

6. Participated in any clinical study with an investigational drug, biologic, or device within 1 month prior to dosing

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Orlando Clinical Research Center	Orlando	Florida	United States	32809

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: NCT00828932
• Other Study ID Numbers: APD356-017
• First Posted: Jan 26, 2009
• Last Update Posted: Sep 12, 2019
• Last Verified: Jul 1, 2009

• Additional relevant MeSH terms: Liver Diseases

Study Results

No Results Posted as of Sep 12, 2019