NCT03887884

Pharmacokinetic Study of CVT-301 (Levodopa Inhalation Powder)

Randomized, Multi-center, Open-label, Crossover Pharmacokinetic Study of CVT-301 (Levodopa Inhalation Powder) and an Oral Dose of Carbidopa/Levodopa CD/LD Under Fed Conditions in Patients With Parkinson's Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Acorda Therapeutics · Industry
• Sex: All
• Age: 30 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study will be an open-label, randomized, multi-center, 2-way crossover Pharmacokinetic PK evaluation of a single inhaled dose of CVT-301 84 mg and a single oral dose of carbidopa/levodopa CD/LD 25 mg/100 mg (Sinemet®) under fed conditions in Parkinson's Disease (PD) patients who regularly take CD/LD.

Detailed description

The study duration includes a screening period followed by an overnight stay in the center (4 days, 3 nights) to complete 2 treatments, including a 48-hour interval between the treatments, and a follow-up phone call 1-2 days after discharge from the center. On each of two treatment days, subjects will consume a standard high fat meal and then receive either (A) a single inhaled dose of CVT-301 or (B) a single dose of oral CD/LD followed by Pharmacokinetic (PK) sampling for 4 hours. A crossover design will be used such that each subject receives both Treatment A and Treatment B over the 2 treatment days, randomized 1:1 to the treatment sequence AB or BA.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	CVT-301	Levodopa Inhalation Powder
DRUG	Sinemet	Single oral dose of Carbidopa/Levodopa 25 mg/100 mg

Timeline

• Start date: 2019-03-05
• Primary completion: 2019-06-28
• Completion: 2019-06-28
• First posted: 2019-03-25
• Last updated: 2019-08-02

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study