Sustained Release Oral Formulation for Treatment of Parkinson's Disease

University of Minnesota (UMN)

Status and phase: Enrolling; Early Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: levodopa/carbidopa oral formulation A; Drug: levodopa/carbidopa oral formulation B

Study type: Interventional

Funder types: Other

Identifier

NCT05471609

Details and patient eligibility

About

Achieving sustained blood levels of carbidopa/levodopa has been a challenge in the treatment of PD and although levodopa remains the most commonly used drug, motor fluctuations remain a major disability especially in advanced Parkinson's disease. The aim of this study is to determine the efficacy of a novel oral carbidopa-levodopa formulation in achieving a sustained blood level of levodopa and carbidopa in normal volunteers.

Enrollment: 6 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Normal healthy
• Are 18-65 years of age
• Are not currently taking medications regularly
• Able to fast 6 hours (water allowed)

Exclusion criteria

• Pregnancy
• Inability to fast

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

---

6 participants in 2 patient groups

levodopa/carbidopa oral formulation A

Experimental group

Description:

LD/CD will be delivered using an oral device placed in the oral/buccal cavity (between cheek and gum of lower jaw) and delivers continuous release of CD and LD for both transmucosal and gastrointestinal absorption.

Treatment:

Drug: levodopa/carbidopa oral formulation A

levodopa/carbidopa oral formulation B

Experimental group

Description:

LD/CD will be delivered using an oral device placed in the oral/buccal cavity (between cheek and gum of lower jaw) and delivers continuous release of CD and LD for both transmucosal and gastrointestinal absorption.

Treatment:

Drug: levodopa/carbidopa oral formulation B