Parkinson DiseasePhase 1NCT02812394
A Study to Compare Two Dose Strengths of CVT-301 (Levodopa Inhalation Powder) With an Oral Dose of Sinemet® (Carbidopa-levodopa) Tablets
A Phase 1 study testing CVT-301 (Dose Level 1), CVT-301 (Dose Level 2) and Sinemet® in people with Parkinson Disease, run by Acorda Therapeutics at 1 site in United States.
Trial summary
This study will be an open-label, randomized, three-period cross-over pharmacokinetic evaluation of CVT-301 compared with the Reference Listed Drug (RLD), orally administered carbidopa/levodopa, in healthy volunteers. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- CVT-301 (Dose Level 1), CVT-301 (Dose Level 2) and Sinemet®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Sep 2016
- Phase
- 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- In good general health as determined by medical history, physical examination, electrocardiogram (ECG), vital signs, and clinical laboratory evaluation;
- FEV1/FVC above the 5th percentile of the predicted normal distribution for age and gender;
- Body Mass Index (BMI) between 18 - 30 kg/m2
Who cannot join
- No flu-like syndrome or other respiratory infections within 2 weeks prior to the Screening Visit;
- Negative drug and alcohol testing;
- Negative pregnancy test for female subjects
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Single Dose Pharmacokinetic Bridging Study to Compare Two Dose Strengths of CVT-301 (Levodopa Inhalation Powder) With an Oral Dose of Sinemet® (Carbidopa-levodopa) Tablets
This study will be an open-label, randomized, three-period cross-over pharmacokinetic evaluation of CVT-301 compared with the Reference Listed Drug (RLD), orally administered carbidopa/levodopa, in healthy volunteers.
Read the detailed description
The primary objective is to determine the relative bioavailability of two CVT-301 (dose levels 1 and 2) capsules compared with the Reference Listed Drug (RLD) on a per milligram basis.
- Conditions
- Parkinson Disease
- Being tested
- CVT-301 (Dose Level 1), CVT-301 (Dose Level 2), Sinemet®
- Keywords
- Parkinson's disease, Episodic motor fluctuations (OFF periods)
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVT-301 (Dose Level 1)Drug
All subjects will receive a single dose of low-dose CVT-301 with a 1-day washout between the doses.
CVT-301 (Dose Level 2)Drug
All subjects will receive a single dose of high-dose CVT-301 with a 1-day washout between the doses.
Sinemet®Drug
Also called carbidopa/levodopa
All subjects will receive carbidopa/levodopa tablets administered every 8 hours.
| Study group | Role | What they receive |
|---|---|---|
| CVT-301 | Experimental | CVT-301 (Dose Level 1): two (low dose) levodopa fine particle dose (FPD) capsules administered to the lung via oral inhalation using the CVT 301 inhaler.
CVT-301 (Dose Level 2): two (high dose) levodopa FPD capsules administered to the lung via oral inhalation using the CVT 301 inhaler.
Sinemet® (carbidopa/levodopa) Receives: Drug: CVT-301 (Dose Level 1); Drug: CVT-301 (Dose Level 2); Drug: Sinemet® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma drug concentration (Cmax)
Measured: within 15min pre-dose (baseline) and specified time points up to and @ 24h post-dose.
Area under the plasma concentration curve from time 0 to the concentration at 24 hours (AUC0-24h)
Measured: within 15min pre-dose (baseline) and specified time points up to and @ 24h post-dose.
Secondary outcomes (1)
Number of subjects with Adverse Events (AEs) including Serious AEs
Measured: up to 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionAug 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acorda Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charles Oh, MD, Study director, Acorda Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02812394
- Sponsor's protocol ID
- CVT-301-010
- Status last verified
- Oct 2016
- First submitted
- 22 Jun 2016
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Single Dose Pharmacokinetic Bridging Study to Compare Two Dose Strengths of CVT-301 (Levodopa Inhalation Powder) With an Oral Dose of Sinemet® (Carbidopa-levodopa) Tablets
- ClinicalTrials.gov ID
- NCT02812394
- Acronym / sponsor ID
- CVT-301-010
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's disease, Episodic motor fluctuations (OFF periods)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Acorda TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 24 Jun 2016 (estimated)
- 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.
This study will be an open-label, randomized, three-period cross-over pharmacokinetic evaluation of CVT-301 compared with the Reference Listed Drug (RLD), orally administered carbidopa/levodopa, in healthy volunteers.
Detailed description
The primary objective is to determine the relative bioavailability of two CVT-301 (dose levels 1 and 2) capsules compared with the Reference Listed Drug (RLD) on a per milligram basis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CVT-301 | Experimental | Drug: CVT-301 (Dose Level 1), Drug: CVT-301 (Dose Level 2), Drug: Sinemet®CVT-301 (Dose Level 1): two (low dose) levodopa fine particle dose (FPD) capsules administered to the lung via oral inhalation using the CVT 301 inhaler. CVT-301 (Dose Level 2): two (high dose) levodopa FPD capsules administered to the lung via oral inhalation using the CVT 301 inhaler. Sinemet® (carbidopa/levodopa) |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- In good general health as determined by medical history, physical examination, electrocardiogram (ECG), vital signs, and clinical laboratory evaluation;
- FEV1/FVC above the 5th percentile of the predicted normal distribution for age and gender;
- Body Mass Index (BMI) between 18 - 30 kg/m2
Key exclusion criteria (3 listed)
- No flu-like syndrome or other respiratory infections within 2 weeks prior to the Screening Visit;
- Negative drug and alcohol testing;
- Negative pregnancy test for female subjects
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 |
|---|---|---|
| CVT-301 (Dose Level 1)All subjects will receive a single dose of low-dose CVT-301 with a 1-day washout between the doses. | Drug | CVT-301 |
| CVT-301 (Dose Level 2)All subjects will receive a single dose of high-dose CVT-301 with a 1-day washout between the doses. | Drug | CVT-301 |
| Sinemet®Also: carbidopa/levodopaAll subjects will receive carbidopa/levodopa tablets administered every 8 hours. | Drug | CVT-301 |
Primary outcome
Maximum observed plasma drug concentration (Cmax)
Time frame: within 15min pre-dose (baseline) and specified time points up to and @ 24h post-dose.
Area under the plasma concentration curve from time 0 to the concentration at 24 hours (AUC0-24h)
Time frame: within 15min pre-dose (baseline) and specified time points up to and @ 24h post-dose.
1 secondary outcome
Number of subjects with Adverse Events (AEs) including Serious AEs
Time frame: up to 9 days
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 26 Oct 2016.
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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.
Charles Oh, MD study director
Acorda Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CVT-301 (Dose Level 1), CVT-301 (Dose Level 2) and Sinemet® in people with Parkinson Disease, run by Acorda Therapeutics 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 3 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 26 Oct 2016. 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?
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.
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?
Maximum observed plasma drug concentration (Cmax) (time frame: within 15min pre-dose (baseline) and specified time points up to and @ 24h post-dose.). The study lists 2 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 26 Oct 2016.