Â鶹´«Ã½Ó³»­

Â鶹´«Ã½Ó³»­

Explore the latest content from across our publications
Join The Â鶹´«Ã½Ó³»­

Log In

Forgot Password?
Create New Account

Loading... please wait

Abstract Details

Pharmacokinetics of CVT-301 (Inhaled Levodopa) Co-Administered With Oral Carbidopa in Subjects With Parkinson’s Disease (PD) Under Fed Conditions
Movement Disorders
P12 - Poster Session 12 (12:00 PM-1:00 PM)
3-001

To evaluate pharmacokinetic profiles and safety of single doses of CVT-301 84mg, administered with oral carbidopa (CD), and single oral doses of carbidopa/levodopa (CD/LD), under fed conditions, in Parkinson’s disease (PD) subjects.

CVT-301 is an LD inhalation powder for OFF period symptom treatment in PD subjects on an oral dopa-decarboxylase inhibitor/LD regimen.

In an open-label, randomized crossover study, subjects received a single inhaled dose of CVT-301 84mg administered with CD 25mg followed by oral CD/LD (25/100mg), or vice versa, in 2 dosing periods. Four-to-five hours after their morning oral CD/LD dose, subjects ate a high-fat, high-protein meal. Predose pharmacokinetic blood samples were obtained post-meal, followed by CVT-301 administered with oral CD 25mg or oral CD/LD 25mg/100mg. Blood was sampled for plasma LD concentrations at 5/10/15/30/45 minutes and 1/1.5/2/3/4 hours postdose. Safety assessments included treatment-emergent adverse events (TEAEs).

23 subjects (mean age 69.3 years, BMI 26.9, PD duration 8.2 years, baseline LD dose 461mg/day) were enrolled: 17% at Hoehn and Yahr stages 1-1.5; 57%, stage 2; 26%, stages 2.5-3. One subject discontinued due to TEAE of cough. Primary pharmacokinetic analyses were based on LD concentrations without baseline LD adjustment. Median Tmax for CVT-301 was 15min vs 120min for oral CD/LD (P<0.001). Cmax was lower for CVT-301 (590.3ng/mL) than oral CD/LD (844.3ng/mL). C10min, C15min, and C30min values for CVT-301 were approximately twice those for oral CD/LD (523-552 vs 247-301ng/mL). Coefficient of variation% for CVT-301 was smaller than oral CD/LD. Nine (39.1%) and 2 (9.1%) subjects reported TEAEs following CVT-301 and oral CD/LD administration, respectively. Most common TEAE was cough:7 (30.4%) in the CVT-301 group vs 1 (4.5%) subject administered oral CD/LD.

In this study pharmacokinetic parameters showed that CVT-301 was more rapidly absorbed and demonstrated lower inter-subject variability than oral CD/LD in the fed condition.
Authors/Disclosures
Beth E. Safirstein, MD (Velocity Clinical Research, Hallandale Beach)
PRESENTER 		No disclosure on file
Aaron Ellenbogen, DO Dr. Ellenbogen has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for allergan. Dr. Ellenbogen has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for allergan. Dr. Ellenbogen has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Teva. Dr. Ellenbogen has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Supernus. Dr. Ellenbogen has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for ipsen. Dr. Ellenbogen has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Acorda.
No disclosure on file
Herbert Henney, PharmD (Acorda Therapeutics, Inc.) No disclosure on file
Deena M. Kegler-Ebo, PhD (Neurelis, Inc.) Dr. Kegler-Ebo has received personal compensation for serving as an employee of Acorda Therapeutics. Dr. Kegler-Ebo has received stock or an ownership interest from Acorda Therapeutics.
Charles Oh, MD No disclosure on file