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

An Open Label, Repeat Dose, Dose Escalation Study Conducted in RLS Patients to Characterize Pharmacokinetics and Food Effect of Ropinirole Controlled Release for RLS

Sponsors

Lead Sponsor: GlaxoSmithKline

Source GlaxoSmithKline
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.

Overall Status Completed
Start Date 2006-08-24
Completion Date 2006-12-12
Primary Completion Date 2006-12-12
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Ropinirole AUC (area under the plasma concentration-time curve) over the dosing interval Ropinirole maximum plasma concentration dosing interval
Secondary Outcome
Measure Time Frame
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
Enrollment 32
Condition
Intervention

Intervention Type: Drug

Intervention Name: Ropinirole

Description: 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.

Eligibility

Criteria:

Inclusion criteria: - 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) Exclusion criteria: - 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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

65 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
GSK Clinical Trials Study Director GlaxoSmithKline
Location
Facility:
GSK Investigational Site | Berlin, 14050, Germany
GSK Investigational Site | George, 6530, South Africa
Location Countries

Germany

South Africa

Verification Date

2017-10-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 6
Arm Group

Label: Sequence WAXBYZCDE

Type: Experimental

Description: 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).

Label: Sequence WAXBYZCED

Type: Experimental

Description: 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).

Label: Sequence WAXBYZDCE

Type: Experimental

Description: 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).

Label: Sequence WAXBYZDEC

Type: Experimental

Description: 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).

Label: Sequence WAXBYZECD

Type: Experimental

Description: 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).

Label: Sequence WAXBYZEDC

Type: Experimental

Description: 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).

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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