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

NCT00460148 | Completed Phase 2

• 1 other identifier: ROP109087
• Study Type: interventional
• Target: 28
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Parkinson Disease

Keywords

ropinirole PR/CR,; pharmacokinetic,; formulation,; food effect,; SK&F101468,; PD

Outcome Measures

Primary Outcomes (1)

• Ropinirole AUC, the area under the plasma concentration-time curve over 24 hours Ropinirole maximum plasma concentration over 24 hours

  24 hours

Secondary Outcomes (2)

• Time to attain the maximum plasma concentration Incidence of adverse events over 37 days As above, but for ropinirole metabolites

  over 37 days

• Vital signs, ECG and clinical laboratory data over 37 days

  over 37 days

Interventions

Ropinirole DRUG

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

GSK Investigational Site

Berlin, State of Berlin, 10117, Germany

Location

GSK Investigational Site

George, Eastern Cape, 6529, South Africa

Location

Related Publications (1)

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

  BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Parkinson Disease

Interventions

ropinirole

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2007
• First Posted: April 13, 2007
• Study Start: April 1, 2007
• Study Completion: August 1, 2007
• Last Updated: October 28, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

ZA (1); DE (1)