Comparison of IPX054, IR Carbidopa-Levodopa, and CR Carbidopa-Levodopa in Subjects With Parkinson's Disease

Study Overview
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Brief Summary
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The objective of this study is to compare the pharmacokinetics and pharmacodynamics of IPX054, carbidopa-levodopa immediate-release tablets, and carbidopa-levodopa controlled-release tablets in subjects with idiopathic Parkinson's disease.

Detailed Description
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IPX054 contains two different drugs called levodopa and carbidopa in one tablet. levodopa turns into a material called 'dopamine' in your brain. The dopamine helps to improve the symptoms of your Parkinson's disease. carbidopa belongs to a group of medicines called 'aromatic amino acid decarboxylase inhibitors'. It helps levodopa work more effectively by slowing the speed at which levodopa is broken down in your body.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Compare IPX054 200 mg and 250 mg to CD-LD IR 200 (2x100) mg Tablets and CD-LD CR 200 mg Tablet in Subjects With Parkinson's Disease

Conditions
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Idiopathic Parkinson's Disease

Intervention / Treatment
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* Drug: IPX054 200 mg
* Drug: IPX054 250 mg
* Drug: CD-LD IR
* Drug: CD-LD CR
* Drug: IPX054 200 mg Placebo
* Drug: IPX054 250 mg Placebo
* Drug: CD-LD IR Placebo
* Drug: CD-LD CR Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with idiopathic Parkinson's disease. Currently being treated with immediate-release or controlled-release carbidopa-levodopa and not requiring more than 200 mg levodopa per dose. Must experience wearing OFF between doses of medication. Exclusion Criteria: Diagnosed with atypical parkinsonism. Allergic or non-responsive to previous carbidopa-levodopa therapy. Active or history of narrow-angle or wide-angle glaucoma. History of seizure or epilepsy, or is currently taking an anti-convulsant for treatment of seizures. Treatment with any neuroleptic agent, including atypical neuroleptics, within the previous 12 months. Treatment with any dopaminergic blocking agent within the previous 3 months.

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sequence 1<br>Subjects take 1 tablet of IPX054 200 mg, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo. In Second treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo. In Third treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR and 1 tablet of CD-LD CR Placebo. In Fourth treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR. | Drug: IPX054 200 mg<br>* IPX054 tablet containing 50 mg carbidopa and 200 mg levodopa<br>Drug: IPX054 250 mg<br>* IPX054 tablet containing 62.5 mg carbidopa and 250 mg levodopa<br>Drug: CD-LD IR<br>* Active comparator containing 25 mg carbidopa and 100 mg levodopa<br>* Other names: Carbidopa-levodopa immediate-release tablets;Drug: CD-LD CR<br>* Active comparator containing 50 mg carbidopa and 200 mg levodopa<br>* Other names: Carbidopa-levodopa controlled-release tablets;Drug: IPX054 200 mg Placebo<br>* Placebo to match IPX054 200 mg<br>Drug: IPX054 250 mg Placebo<br>* Placebo to match IPX054 250 mg<br>Drug: CD-LD IR Placebo<br>* Placebo to match CD-LD IR<br>Drug: CD-LD CR Placebo<br>* Placebo to match CD-LD CR<br>|
| Other: Sequence 2<br>Subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo. In Second treatment, subjects take 1 tablet of IPX054 200 mg, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo. In Third treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR. In Fourth treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR and 1 tablet of CD-LD CR Placebo. | Drug: IPX054 200 mg<br>* IPX054 tablet containing 50 mg carbidopa and 200 mg levodopa<br>Drug: IPX054 250 mg<br>* IPX054 tablet containing 62.5 mg carbidopa and 250 mg levodopa<br>Drug: CD-LD IR<br>* Active comparator containing 25 mg carbidopa and 100 mg levodopa<br>* Other names: Carbidopa-levodopa immediate-release tablets;Drug: CD-LD CR<br>* Active comparator containing 50 mg carbidopa and 200 mg levodopa<br>* Other names: Carbidopa-levodopa controlled-release tablets;Drug: IPX054 200 mg Placebo<br>* Placebo to match IPX054 200 mg<br>Drug: IPX054 250 mg Placebo<br>* Placebo to match IPX054 250 mg<br>Drug: CD-LD IR Placebo<br>* Placebo to match CD-LD IR<br>Drug: CD-LD CR Placebo<br>* Placebo to match CD-LD CR<br>|
| Other: Sequence 3<br>Subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR and 1 tablet of CD-LD CR Placebo. In Second treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR. In Third treatment, subjects take 1 tablet of IPX054 200 mg, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo. In Fourth treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo. | Drug: IPX054 200 mg<br>* IPX054 tablet containing 50 mg carbidopa and 200 mg levodopa<br>Drug: IPX054 250 mg<br>* IPX054 tablet containing 62.5 mg carbidopa and 250 mg levodopa<br>Drug: CD-LD IR<br>* Active comparator containing 25 mg carbidopa and 100 mg levodopa<br>* Other names: Carbidopa-levodopa immediate-release tablets;Drug: CD-LD CR<br>* Active comparator containing 50 mg carbidopa and 200 mg levodopa<br>* Other names: Carbidopa-levodopa controlled-release tablets;Drug: IPX054 200 mg Placebo<br>* Placebo to match IPX054 200 mg<br>Drug: IPX054 250 mg Placebo<br>* Placebo to match IPX054 250 mg<br>Drug: CD-LD IR Placebo<br>* Placebo to match CD-LD IR<br>Drug: CD-LD CR Placebo<br>* Placebo to match CD-LD CR<br>|
| Other: Sequence 4<br>Subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR. In Second treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR and 1 tablet of CD-LD CR Placebo. In Third treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo. In Fourth treatment, subjects take 1 tablet of IPX054 200 mg, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo. | Drug: IPX054 200 mg<br>* IPX054 tablet containing 50 mg carbidopa and 200 mg levodopa<br>Drug: IPX054 250 mg<br>* IPX054 tablet containing 62.5 mg carbidopa and 250 mg levodopa<br>Drug: CD-LD IR<br>* Active comparator containing 25 mg carbidopa and 100 mg levodopa<br>* Other names: Carbidopa-levodopa immediate-release tablets;Drug: CD-LD CR<br>* Active comparator containing 50 mg carbidopa and 200 mg levodopa<br>* Other names: Carbidopa-levodopa controlled-release tablets;Drug: IPX054 200 mg Placebo<br>* Placebo to match IPX054 200 mg<br>Drug: IPX054 250 mg Placebo<br>* Placebo to match IPX054 250 mg<br>Drug: CD-LD IR Placebo<br>* Placebo to match CD-LD IR<br>Drug: CD-LD CR Placebo<br>* Placebo to match CD-LD CR<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alternate tapping of keys |  | single dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed walking |  | single dose | 
| Tremor score |  | single dose | 
| Dyskinesia rating scale |  | single dose |