Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole

October 27, 2016 updated by: GlaxoSmithKline

An Open Label, Repeat Dose, Dose Escalation Study Conducted in Parkinson's Disease Patients to Characterize the Pharmacokinetics and Effect of Food on Ropinirole Prolonged Release (PR/CR) 12mg Tablets.

This study in PD patients is designed to assess the affect food has on the absorption, distribution, metabolism and excretion of ropinirole (by dosing some patients in the fasted state and other patients following a high-fat breakfast), and to assess the difference in absorption, distribution, metabolism and excretion of ropinirole if patients are given three 4mg ropinirole tablets versus one 12mg tablet.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Berlin, Germany, 10117
        • GSK Investigational Site
    • Eastern Cape
      • George, Eastern Cape, South Africa, 6529
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female patients aged between 30 and 85 years of age
  • Body mass index of 18 to 32 kg/m2, body weight of at least 50 kg.
  • Diagnosis of idiopathic Parkinson's disease
  • Patients must have provided written informed consent prior to performing any study procedures
  • QTc interval of < 450ms (or QTc < 480ms in patients with Bundle Branch Block).

Exclusion Criteria:

  • Patients who have an abnormality on physical examination.
  • Patients who have medical conditions which could present a safety concern.
  • Patients who have a clinically significant abnormal laboratory value, ECG, or physical examination finding
  • Positive result for Hepatitis B surface antigen, Hepatitis C antibody or Human Immunodeficiency Virus (HIV) antibody
  • Positive alcohol test result and / or urine test for undeclared drugs
  • Recent history of moderate to severe dizziness, syncope, or orthostatic hypotension
  • Significant sleep disorder or Epworth Sleep Score (Appendix 5) > 9
  • Patients with a lying/sitting diastolic blood pressure =110mmHg or =50mmHg or a systolic blood pressure =180mmHg or =90mmHg
  • History of any dopaminergic treatment (other than ropinirole IR and L-dopa) within 2 weeks prior to first dose.
  • Withdrawal, introduction, or change in dose of hormone replacement therapy and/or any drug known to substantially inhibit CYP1A2 or induce CYP1A2
  • Patients who smoke >20 cigarettes per day and will not maintain a constant smoking habit for the duration of the study.
  • Blood donation or significant blood loss less than 90 days before Day 1 of the current study.
  • Definite or suspected personal history, or family history, of adverse reactions or hypersensitivity to ropinirole or to drugs with a similar chemical structure.
  • Use of any investigational drug (with the exception of ropinirole PR/CR) within 30 days or 5 half lives (whichever is longer) before the start of dosing with study medication.
  • Patients who have received over-the-counter (OTC) medicine within 48 h before the first dose of study drug.
  • Recent history, or suspicion, of drug dependence or abuse of alcohol
  • Significant concern, or likelihood, that the patient will drop out of the study prematurely, will require new or prohibited concomitant medications during the study period, or will not be compliant with study procedures.
  • Women who are pregnant or breast-feeding.
  • Female patient is currently either of:

    1. Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal or any female who is surgically sterilized (via documented hysterectomy or bilateral tubal ligation).

      (For purposes of this study, postmenopausal is defined as one year without menses) OR

    2. child-bearing potential, has a negative urine/serum pregnancy test at the Screening Visit (prior to investigational product administration), and agrees to use acceptable contraception from one month prior to study Day 1 until one month after completion of the study (ie. one month after the follow-up visit). All hormonal birth control must have been administered for at least one monthly cycle prior to the Screening Visit. GSK acceptable contraception methods, when used consistently and in accordance with both the product label and the instructions of a physician, are as follows:

      • complete abstinence
      • sterilization of patient's male partner prior to female patient's entry into study
      • oral contraceptive (either combined or progestogen only)
      • any intra-uterine device with a documented failure rate of less than 1% per year
      • systemic contraception (eg. norplant system)
      • double barrier method if comprised of a spermicide with either a condom or diaphragm
  • Patients with prior or current major psychosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ropinirole AUC, the area under the plasma concentration-time curve over 24 hours Ropinirole maximum plasma concentration over 24 hours
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to attain the maximum plasma concentration Incidence of adverse events over 37 days As above, but for ropinirole metabolites
Time Frame: over 37 days
over 37 days
Vital signs, ECG and clinical laboratory data over 37 days
Time Frame: over 37 days
over 37 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • This study has not been published in the scientific literature.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

April 11, 2007

First Submitted That Met QC Criteria

April 11, 2007

First Posted (Estimate)

April 13, 2007

Study Record Updates

Last Update Posted (Estimate)

October 28, 2016

Last Update Submitted That Met QC Criteria

October 27, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

  1. Dataset Specification
    Information identifier: ROP109087
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Annotated Case Report Form
    Information identifier: ROP109087
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Clinical Study Report
    Information identifier: ROP109087
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Study Protocol
    Information identifier: ROP109087
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Informed Consent Form
    Information identifier: ROP109087
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Individual Participant Data Set
    Information identifier: ROP109087
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Statistical Analysis Plan
    Information identifier: ROP109087
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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