Sustained Release Oral Formulation for Treatment of Parkinson's Disease

NCT05471609 | Recruiting Early Phase 1 FDA Drug

• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Carbidopa/levodopa serum level Efficacy of the delivery method

  Carbidopa/levodopa serum level

  4 times, then every 60 mins for a total of 6 hours after administration (total of 9 blood samples)

Study Arms (2)

levodopa/carbidopa oral formulation A

EXPERIMENTAL

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.

Drug: levodopa/carbidopa oral formulation A

levodopa/carbidopa oral formulation B

EXPERIMENTAL

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.

Drug: levodopa/carbidopa oral formulation B

Interventions

levodopa/carbidopa oral formulation A DRUG

Outer sachet 100mg CD/100mg LD and inner sachet 0mg CD /300mg LD

levodopa/carbidopa oral formulation A

levodopa/carbidopa oral formulation B DRUG

Outer sachet 100mg CD/0mg LD and inner sachet 0mg CD /400mg LD

levodopa/carbidopa oral formulation B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnancy
• Inability to fast

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Interventions

Levodopa

Intervention Hierarchy (Ancestors)

Dihydroxyphenylalanine; Catecholamines; Amines; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Tyrosine

Study Officials

• Khalaf Bushara, MD,FRCP

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Coordinator

CONTACT

507-339-4093; umnstudies@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blinded
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 different assemblies with 2 different formulations (A, B) will be used.

Study Record Dates

• First Submitted: July 20, 2022
• First Posted: July 25, 2022
• Study Start: June 12, 2025
• Primary Completion (Estimated): June 16, 2026
• Study Completion (Estimated): June 16, 2026
• Last Updated: July 10, 2025

Record last verified: 2025-07

Locations

US (1)