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NCT Number: NCT07709741

Sustained Release Oral Formulation For Treatment Of Parkinsons Disease

LD/CD (medications to treat Parkinson's disease) will be delivered using an assembly of nested sachets made of permeable material. The assembly is 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. The combination of CD/LD in the inner sachet varies from that in the outer sachet. This allows for sequential release of CD and then LD to mimic a CD pretreatment method which is known to increase LD absorption and prolong its half-life.

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Key information

Conditions

Healthy Volunteers Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location contact

Khalaf Bushara, MD, FRCP

CONTACT

[email protected]

612-725-2000 ext. x4233

Khalaf Bushara, MD, FRCP

PRINCIPAL_INVESTIGATOR

About this study

This is a randomized, double-blind (dose-masked), single-dose crossover study to investigate the pharmacokinetics of a novel delivery method and formulation of different doses of CD/LD in normal volunteers.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult healthy male or female
  • Age 18 to 65 years
  • Willingness and ability to complete study procedures

Exclusion criteria

  • medical conditions that require taking medications regularly.

Treatment and study plan

Formulation A

Drug

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

Other names: Study Drug A

Formulation B

Drug

outer sachet 150mg CD/0mg LD and inner sachet 600mg LD

Other names: Study Drug B

Formulation C

Drug

outer sachet 200mg CD/0mg LD and inner sachet 800mg LD

Other names: Study Drug C

Primary outcomes

  1. Blood CD Level - Minute 15

    Time frame: Minute 15 after administration

    Measured in [ng/mL]

  2. Blood LD Level - Minute 15

    Time frame: Minute 15 after administration

    Measured in [ng/mL]

  3. Blood CD Level - Minute 30

    Time frame: Minute 30 after administration

    Measured in [ng/mL]

  4. Blood LD Level - Minute 30

    Time frame: Minute 30 after administration

    Measured in [ng/mL]

  5. Blood CD Level - Minute 45

    Time frame: Minute 45 after administration

    Measured in [ng/mL]

  6. Blood LD Level - Minute 45

    Time frame: Minute 45 after administration

    Measured in [ng/mL]

  7. Blood CD Level - Hour 1

    Time frame: One hour after administration

    Measured in [ng/mL]

  8. Blood LD Level - Hour 1

    Time frame: One hour after administration

    Measured in [ng/mL]

  9. Blood CD Level - Hour 2

    Time frame: Two hours after administration

    Measured in [ng/mL]

  10. Blood LD Level - Hour 2

    Time frame: Two hours after administration

    Measured in [ng/mL]

  11. Blood CD Level - Hour 3

    Time frame: Three hours after administration

    Measured in [ng/mL]

  12. Blood LD Level - Hour 3

    Time frame: Three hours after administration

    Measured in [ng/mL]

  13. Blood CD Level - Hour 4

    Time frame: Four hours after administration

    Measured in [ng/mL]

  14. Blood LD Level - Hour 4

    Time frame: Four hours after administration

    Measured in [ng/mL]

  15. Blood CD Level - Hour 5

    Time frame: Five hours after administration

    Measured in [ng/mL]

  16. Blood LD Level - Hour 5

    Time frame: Five hours after administration

    Measured in [ng/mL]

  17. Blood CD Level - Hour 6

    Time frame: Six hours after administration

    Measured in [ng/mL]

  18. Blood LD Level - Hour 6

    Time frame: Six hours after administration

    Measured in [ng/mL]

  19. Blood CD Level - Hour 7

    Time frame: Seven hours after administration

    Measured in [ng/mL]

  20. Blood LD Level - Hour 7

    Time frame: Seven hours after administration

    Measured in [ng/mL]

  21. Blood CD Level - Hour 8

    Time frame: Eight hours after administration

    Measured in [ng/mL]

  22. Blood LD Level - Hour 8

    Time frame: Eight hours after administration

    Measured in [ng/mL]

Study contacts

Contact information is provided by the study sponsor or research team.

Khalaf Bushara, MD, FRCP

CONTACT

[email protected]

‪(612) 460-5734‬

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 16, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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