Healthy VolunteersEarly Phase 1NCT05471609
Sustained Release Oral Formulation for Treatment of Parkinson's Disease
A Early Phase 1 study testing levodopa/carbidopa oral formulation A and levodopa/carbidopa oral formulation B in people with Healthy Volunteers, run by University of Minnesota at 1 site in United States.
Trial 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. 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?
- levodopa/carbidopa oral formulation A and levodopa/carbidopa oral formulation B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2025to 14 Aug 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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
- Normal healthy
- Are 18-65 years of age
- Are not currently taking medications regularly
- Able to fast 6 hours (water allowed)
Who cannot join
- Pregnancy
- Inability to fast
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
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
- Being tested
- levodopa/carbidopa oral formulation A, levodopa/carbidopa oral formulation B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levodopa/carbidopa oral formulation ADrug
Outer sachet 100mg CD/100mg LD and inner sachet 0mg CD /300mg LD
levodopa/carbidopa oral formulation BDrug
Outer sachet 100mg CD/0mg LD and inner sachet 0mg CD /400mg LD
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: levodopa/carbidopa oral formulation B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carbidopa/levodopa serum level Efficacy of the delivery method
Carbidopa/levodopa serum level
Measured: 4 times, then every 60 mins for a total of 6 hours after administration (total of 9 blood samples)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start12 Jun 2025
- Primary completion14 Aug 2025
- Study completion14 Aug 2025
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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- 2 different assemblies with 2 different formulations (A, B) will be used.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 6 participants (actual)
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
- NCT05471609
- Status last verified
- Jun 2026
- First submitted
- 20 Jul 2022
- Last updated
- 25 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustained Release Oral Formulation for Treatment of Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05471609
- Conditions
- Healthy Volunteers
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 12 Jun 2025 (actual)
- Primary completion
- 14 Aug 2025 (actual)
- Study completion
- 14 Aug 2025 (actual)
- First posted
- 25 Jul 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 2 different assemblies with 2 different formulations (A, B) will be used.
| Arm | Type | Receives |
|---|---|---|
| levodopa/carbidopa oral formulation A | Experimental | Drug: levodopa/carbidopa oral formulation ALD/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. |
| levodopa/carbidopa oral formulation B | Experimental | Drug: levodopa/carbidopa oral formulation BLD/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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Normal healthy
- Are 18-65 years of age
- Are not currently taking medications regularly
- Able to fast 6 hours (water allowed)
Key exclusion criteria (2 listed)
- Pregnancy
- Inability to fast
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 |
|---|---|---|
| levodopa/carbidopa oral formulation AOuter sachet 100mg CD/100mg LD and inner sachet 0mg CD /300mg LD | Drug | levodopa/carbidopa oral formulation A |
| levodopa/carbidopa oral formulation BOuter sachet 100mg CD/0mg LD and inner sachet 0mg CD /400mg LD | Drug | levodopa/carbidopa oral formulation B |
Primary outcome
Carbidopa/levodopa serum level Efficacy of the delivery method
Time frame: 4 times, then every 60 mins for a total of 6 hours after administration (total of 9 blood samples)
Carbidopa/levodopa serum level
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
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 Early Phase 1 study testing levodopa/carbidopa oral formulation A and levodopa/carbidopa oral formulation B 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 25 Jun 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Carbidopa/levodopa serum level Efficacy of the delivery method (time frame: 4 times, then every 60 mins for a total of 6 hours after administration (total of 9 blood samples)). 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 25 Jun 2026.