Pharmacokinetic Properties of Lorcaserin in Subjects With Hepatic Impairment

An Open Label, Single Dose Study of the Pharmacokinetic Properties of Lorcaserin in Subjects With Hepatic Impairment

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

Study Overview

• Status: Completed
• Conditions: Hepatic Impairment
• Intervention / Treatment: Drug: Lorcaserin

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)
4. All subjects will have a BMI of 27-45 kg/m2, inclusive.
5. Eligible male and female patients must agree not to participate in a conception process
6. 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
5. 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
6. Malignancy within 2 years of the screening visit (except basal cell or squamous cell carcinoma with clean surgical margins)
7. Initiation of a new prescription medication within 1 month prior to screening.
8. 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.
9. Use of SSRI's, SNRI's, and other medications must meet the required washout periods.
10. Participated in any clinical study with an investigational drug, biologic, or device within 1 month prior to dosing

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
To evaluate the safety and tolerability of lorcaserin

Collaborators and Investigators

• Sponsor: Eisai Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: January 22, 2009
• First Submitted That Met QC Criteria: January 23, 2009
• First Posted (Estimate): January 26, 2009

Study Record Updates

• Last Update Posted (Actual): September 12, 2019
• Last Update Submitted That Met QC Criteria: September 11, 2019
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: APD356-017