Healthy VolunteersPhase 1/2NCT07709741
Sustained Release Oral Formulation For Treatment Of Parkinsons Disease
A Phase 1/2 study testing Formulation A, Formulation B and Formulation C in people with Healthy Volunteers, run by University of Minnesota at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Formulation A, Formulation B and Formulation C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2027to 30 Jun 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult healthy male or female
- Age 18 to 65 years
- Willingness and ability to complete study procedures
Who cannot join
- medical conditions that require taking medications regularly.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
Khalaf Bushara, MD, FRCP, 612-725-2000 ext. x4233, busha001@umn.edu
Khalaf Bushara, MD, FRCP
About this study
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.
Read the detailed description
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.
- Conditions
- Healthy Volunteers
- Being tested
- Formulation A, Formulation B, Formulation C
- Keywords
- Parkinson's, Levidopa, Carbidopa
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formulation ADrug
Also called Study Drug A
outer sachet 100 mg CD/0mg LD and inner sachet 0mg CD /400mg LD
Formulation BDrug
Also called Study Drug B
outer sachet 150mg CD/0mg LD and inner sachet 600mg LD
Formulation CDrug
Also called Study Drug C
outer sachet 200mg CD/0mg LD and inner sachet 800mg LD
| Study group | Role | What they receive |
|---|---|---|
| Formulation A | Active comparator | Two sachets nested between the lower jaw, gum, and cheek; outer sachet 100 mg CD/0mg LD and inner sachet 0mg CD /400mg LD Receives: Drug: Formulation A |
| Formulation B | Active comparator | Two sachets nested between the lower jaw, gum, and cheek; outer sachet 150mg CD/0mg LD and inner sachet 600mg LD Receives: Drug: Formulation B |
| Formulation C | Active comparator | Two sachets nested between the lower jaw, gum, and cheek; outer sachet 200mg CD/0mg LD and inner sachet 800mg LD Receives: Drug: Formulation C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood CD Level - Minute 15
Measured in [ng/mL]
Measured: Minute 15 after administration
Blood LD Level - Minute 15
Measured in [ng/mL]
Measured: Minute 15 after administration
Blood CD Level - Minute 30
Measured in [ng/mL]
Measured: Minute 30 after administration
Blood LD Level - Minute 30
Measured in [ng/mL]
Measured: Minute 30 after administration
Blood CD Level - Minute 45
Measured in [ng/mL]
Measured: Minute 45 after administration
Blood LD Level - Minute 45
Measured in [ng/mL]
Measured: Minute 45 after administration
Blood CD Level - Hour 1
Measured in [ng/mL]
Measured: One hour after administration
Blood LD Level - Hour 1
Measured in [ng/mL]
Measured: One hour after administration
Blood CD Level - Hour 2
Measured in [ng/mL]
Measured: Two hours after administration
Blood LD Level - Hour 2
Measured in [ng/mL]
Measured: Two hours after administration
Blood CD Level - Hour 3
Measured in [ng/mL]
Measured: Three hours after administration
Blood LD Level - Hour 3
Measured in [ng/mL]
Measured: Three hours after administration
Blood CD Level - Hour 4
Measured in [ng/mL]
Measured: Four hours after administration
Blood LD Level - Hour 4
Measured in [ng/mL]
Measured: Four hours after administration
Blood CD Level - Hour 5
Measured in [ng/mL]
Measured: Five hours after administration
Blood LD Level - Hour 5
Measured in [ng/mL]
Measured: Five hours after administration
Blood CD Level - Hour 6
Measured in [ng/mL]
Measured: Six hours after administration
Blood LD Level - Hour 6
Measured in [ng/mL]
Measured: Six hours after administration
Blood CD Level - Hour 7
Measured in [ng/mL]
Measured: Seven hours after administration
Blood LD Level - Hour 7
Measured in [ng/mL]
Measured: Seven hours after administration
Blood CD Level - Hour 8
Measured in [ng/mL]
Measured: Eight hours after administration
Blood LD Level - Hour 8
Measured in [ng/mL]
Measured: Eight hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start1 Apr 2027 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Khalaf Bushara, MD, FRCP, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07709741
- Sponsor's protocol ID
- NEUR-2021-29687
- Status last verified
- Sep 2026
- First submitted
- 6 Jul 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustained Release Oral Formulation For Treatment Of Parkinsons Disease
- ClinicalTrials.gov ID
- NCT07709741
- Acronym / sponsor ID
- NEUR-2021-29687
- Conditions
- Healthy Volunteers
- Keywords
- Parkinson's, Levidopa, Carbidopa
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Apr 2027 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Formulation A | Active comparator | Drug: Formulation ATwo sachets nested between the lower jaw, gum, and cheek; outer sachet 100 mg CD/0mg LD and inner sachet 0mg CD /400mg LD |
| Formulation B | Active comparator | Drug: Formulation BTwo sachets nested between the lower jaw, gum, and cheek; outer sachet 150mg CD/0mg LD and inner sachet 600mg LD |
| Formulation C | Active comparator | Drug: Formulation CTwo sachets nested between the lower jaw, gum, and cheek; outer sachet 200mg CD/0mg LD and inner sachet 800mg LD |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult healthy male or female
- Age 18 to 65 years
- Willingness and ability to complete study procedures
Key exclusion criteria (1 listed)
- medical conditions that require taking medications regularly.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Formulation AAlso: Study Drug Aouter sachet 100 mg CD/0mg LD and inner sachet 0mg CD /400mg LD | Drug | Formulation A |
| Formulation BAlso: Study Drug Bouter sachet 150mg CD/0mg LD and inner sachet 600mg LD | Drug | Formulation B |
| Formulation CAlso: Study Drug Couter sachet 200mg CD/0mg LD and inner sachet 800mg LD | Drug | Formulation C |
Primary outcome
Blood CD Level - Minute 15
Time frame: Minute 15 after administration
Measured in [ng/mL]
Blood LD Level - Minute 15
Time frame: Minute 15 after administration
Measured in [ng/mL]
Blood CD Level - Minute 30
Time frame: Minute 30 after administration
Measured in [ng/mL]
Blood LD Level - Minute 30
Time frame: Minute 30 after administration
Measured in [ng/mL]
Blood CD Level - Minute 45
Time frame: Minute 45 after administration
Measured in [ng/mL]
Blood LD Level - Minute 45
Time frame: Minute 45 after administration
Measured in [ng/mL]
Blood CD Level - Hour 1
Time frame: One hour after administration
Measured in [ng/mL]
Blood LD Level - Hour 1
Time frame: One hour after administration
Measured in [ng/mL]
Blood CD Level - Hour 2
Time frame: Two hours after administration
Measured in [ng/mL]
Blood LD Level - Hour 2
Time frame: Two hours after administration
Measured in [ng/mL]
Blood CD Level - Hour 3
Time frame: Three hours after administration
Measured in [ng/mL]
Blood LD Level - Hour 3
Time frame: Three hours after administration
Measured in [ng/mL]
Blood CD Level - Hour 4
Time frame: Four hours after administration
Measured in [ng/mL]
Blood LD Level - Hour 4
Time frame: Four hours after administration
Measured in [ng/mL]
Blood CD Level - Hour 5
Time frame: Five hours after administration
Measured in [ng/mL]
Blood LD Level - Hour 5
Time frame: Five hours after administration
Measured in [ng/mL]
Blood CD Level - Hour 6
Time frame: Six hours after administration
Measured in [ng/mL]
Blood LD Level - Hour 6
Time frame: Six hours after administration
Measured in [ng/mL]
Blood CD Level - Hour 7
Time frame: Seven hours after administration
Measured in [ng/mL]
Blood LD Level - Hour 7
Time frame: Seven hours after administration
Measured in [ng/mL]
Blood CD Level - Hour 8
Time frame: Eight hours after administration
Measured in [ng/mL]
Blood LD Level - Hour 8
Time frame: Eight hours after administration
Measured in [ng/mL]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Khalaf Bushara, MD, FRCP principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Formulation A, Formulation B and Formulation C in people with Healthy Volunteers, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Khalaf Bushara, MD, FRCP ((612) 460-5734, umnstudies@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood CD Level - Minute 15 (time frame: Minute 15 after administration). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.