Restless Legs Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole And The Effect Of Food

NCT00419692 | Completed Phase 1

• 1 other identifier: ROR106470
• Study Type: interventional
• Target: 32
• Locations: 2 countries
• Sites: 2

Brief Summary

This study in RLS 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 two 3mg ropinirole tablets versus one 6mg tablet.

Conditions

Restless Legs Syndrome

Keywords

pharmacokinetic,; RLS; formulation,; food effect,; controlled release for RLS,; SK&F101468,

Outcome Measures

Primary Outcomes (1)

• Ropinirole AUC (area under the plasma concentration-time curve) over the dosing interval Ropinirole maximum plasma concentration

  dosing interval

Secondary Outcomes (1)

• Time to attain the maximum plasma concentration Time taken for ropinirole concentration to fall to half initial value Incidence of adverse events Vital signs, ECG and clinical laboratory data As above, but for ropinirole metabolites

  Time taken for ropinirole concentration to fall to half initial value

Study Arms (6)

Sequence WAXBYZCDE

EXPERIMENTAL

Subjects will receive ropinirole as follows W: 1 x 0.5 mg CR-RLS (normal fed), A: 1 x 1 mg CR-RLS (fasted), X: 1 x 2 mg CR-RLS (normal fed), B: 1 x 3 mg CR-RLS (fasted), Y: 2 x 2 mg CR-RLS (normal fed), Z: (2 x 2 mg) + (1 x 1 mg) CR-RLS (normal fed), C: 1 x 6 mg CR-RLS (fasted), D: 1 x 6 mg CR-RLS (high fat fed) and E: 2 x 3 mg CR-RLS (fasted).

Drug: Ropinirole

Sequence WAXBYZCED

EXPERIMENTAL

Subjects will receive ropinirole as follows W: 1 x 0.5 mg CR-RLS (normal fed), A: 1 x 1 mg CR-RLS (fasted), X: 1 x 2 mg CR-RLS (normal fed), B: 1 x 3 mg CR-RLS (fasted), Y: 2 x 2 mg CR-RLS (normal fed), Z: (2 x 2 mg) + (1 x 1 mg) CR-RLS (normal fed), C: 1 x 6 mg CR-RLS (fasted), E: 2 x 3 mg CR-RLS (fasted) and D: 1 x 6 mg CR-RLS (high fat fed).

Drug: Ropinirole

Sequence WAXBYZDCE

EXPERIMENTAL

Subjects will receive ropinirole as follows W: 1 x 0.5 mg CR-RLS (normal fed), A: 1 x 1 mg CR-RLS (fasted), X: 1 x 2 mg CR-RLS (normal fed), B: 1 x 3 mg CR-RLS (fasted), Y: 2 x 2 mg CR-RLS (normal fed), Z: (2 x 2 mg) + (1 x 1 mg) CR-RLS (normal fed), D: 1 x 6 mg CR-RLS (high fat fed), C: 1 x 6 mg CR-RLS (fasted) and E: 2 x 3 mg CR-RLS (fasted).

Drug: Ropinirole

Sequence WAXBYZDEC

EXPERIMENTAL

Subjects will receive ropinirole as follows W: 1 x 0.5 mg CR-RLS (normal fed), A: 1 x 1 mg CR-RLS (fasted), X: 1 x 2 mg CR-RLS (normal fed), B: 1 x 3 mg CR-RLS (fasted), Y: 2 x 2 mg CR-RLS (normal fed), Z: (2 x 2 mg) + (1 x 1 mg) CR-RLS (normal fed), D: 1 x 6 mg CR-RLS (high fat fed), E: 2 x 3 mg CR-RLS (fasted) and C: 1 x 6 mg CR-RLS (fasted).

Drug: Ropinirole

Sequence WAXBYZECD

EXPERIMENTAL

Subjects will receive ropinirole as follows W: 1 x 0.5 mg CR-RLS (normal fed), A: 1 x 1 mg CR-RLS (fasted), X: 1 x 2 mg CR-RLS (normal fed), B: 1 x 3 mg CR-RLS (fasted), Y: 2 x 2 mg CR-RLS (normal fed), Z: (2 x 2 mg) + (1 x 1 mg) CR-RLS (normal fed), E: 2 x 3 mg CR-RLS (fasted),C: 1 x 6 mg CR-RLS (fasted) and D: 1 x 6 mg CR-RLS (high fat fed).

Drug: Ropinirole

Sequence WAXBYZEDC

EXPERIMENTAL

Subjects will receive ropinirole as follows W: 1 x 0.5 mg CR-RLS (normal fed), A: 1 x 1 mg CR-RLS (fasted), X: 1 x 2 mg CR-RLS (normal fed), B: 1 x 3 mg CR-RLS (fasted), Y: 2 x 2 mg CR-RLS (normal fed), Z: (2 x 2 mg) + (1 x 1 mg) CR-RLS (normal fed), E: 2 x 3 mg CR-RLS (fasted), D: 1 x 6 mg CR-RLS (high fat fed) and C: 1 x 6 mg CR-RLS (fasted).

Drug: Ropinirole

Interventions

Ropinirole DRUG

Subjects will receive ropinirole 0.5 mg for first 7 days, 1 mg from Day 8-14, 2 mg from Day 15-21, 3 mg from Day 22-28, 4 mg from Day 29-35, 5 mg from Day 36-42 and 6 mg from Day 43-51.

Sequence WAXBYZCDE; Sequence WAXBYZCED; Sequence WAXBYZDCE; Sequence WAXBYZDEC; Sequence WAXBYZECD; Sequence WAXBYZEDC

Eligibility Criteria

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

You may qualify if:

• Patients with a diagnosis of RLS
• Body mass index of 18 to 32 kg/m², with a body weight of at least 50 kg
• Normal blood pressure pre-study
• Light smokers only (\<20/day)

You may not qualify if:

• History of postural hypotension or faints
• Secondary RLS
• Patients who suffer from a primary sleep disorder other than RLS
• Patients diagnosed with movement disorders
• Patients with unstable medical conditions
• Patients with personal or family history of adverse reactions or hypersensitivity to the study drug
• Patients with abnormal laboratory values
• Patients with hepatitis or HIV
• Patients who abuse alcohol or drugs
• Patients taking the following medications: dopamine agonists (including ropinirole), dopamine antagonists (e.g., metoclopramide and domperidone), levodopa/carbidopa

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

GSK Investigational Site

Berlin, 14050, Germany

Location

GSK Investigational Site

George, 6530, South Africa

Location

Related Links

• Results for study ROR106470 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

ropinirole

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2007
• First Posted: January 9, 2007
• Study Start: August 24, 2006
• Primary Completion: December 12, 2006
• Study Completion: December 12, 2006
• Last Updated: October 13, 2017

Record last verified: 2017-10

Locations

DE (1); ZA (1)