Parkinson DiseasePhase 1NCT02970019
Safety and Tolerability Study of K0706 in Subjects With Parkinson's Disease
A Phase 1 study testing K0706 in people with Parkinson Disease, run by Sun Pharma Advanced Research Company Limited at 5 sites in United States.
Trial summary
This is a safety, tolerability and pharmacokinetic study in subjects with Parkinson's disease Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- K0706
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 5 sitesUnited States
- Study dates
- 30 Mar 2017to 28 May 2019
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to give written, and dated, informed consent (or legally acceptable representative/impartial witness when applicable) and is available for the entire study
- Willing and able to comply with the scheduled visits, treatment plan, laboratory testing, study procedures, and restrictions (in the Investigator's opinion), and be accessible for follow-up
- Male or female aged 18 to 65 years (both inclusive)
- Diagnosed with Parkinson's disease
Who cannot join
- Clinical diagnosis of genetic form of Parkinson's disease, or drug-induced parkinsonism
- Diagnosis of Parkinson's disease Dementia (probable, possible)
- Presence of severe dyskinesias
- History of brain surgery for Parkinson's disease
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
SPARC Site 01
DeLand, Florida, 32720
SPARC Site 03
Long Beach, California, 90806
SPARC Site 02
Orlando, Florida, 32806
SPARC Site 05
Panorama City, California, 91402
SPARC Site 04
Raleigh, North Carolina, 27612
About this study
Official title: A Double-blind, Placebo-controlled Study to Determine Safety, Tolerability, Pharmacokinetic of K0706.
This is a safety, tolerability and pharmacokinetic study in subjects with Parkinson's disease
- Conditions
- Parkinson Disease
- Being tested
- K0706, Placebo
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
K0706Drug
Once a day administration after fast
PlaceboDrug
Once a day administration after fast
| Study group | Role | What they receive |
|---|---|---|
| K0706 | Experimental | K0706 will be administered once a day Receives: Drug: K0706 |
| Placebo | Experimental | Placebo will be administered once a day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Measured: 4 weeks
Secondary outcomes (3)
Peak plasma concentration
Measured: 4 weeks
Area under the plasma concentration versus time curve
Measured: 4 weeks
Time of observed peak plasma concentration
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study start30 Mar 2017
- Primary completion28 May 2019
- Study completion28 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharma Advanced Research Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02970019
- Sponsor's protocol ID
- CLR_16_27
- Status last verified
- Mar 2020
- First submitted
- 18 Nov 2016
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Joshi D, Kulkarni M, Parekh P, Shah S, Greig NH, Acharya S. Targeting protein kinases in Parkinson's disease: the emerging role of phytoconstituents. Nutr Neurosci. 2025 Dec;28(12):1532-1563. doi: 10.1080/1028415X.2025.2531356. Epub 2025 Jul 18.
PubMed 40680102
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled Study to Determine Safety, Tolerability, Pharmacokinetic of K0706.
- ClinicalTrials.gov ID
- NCT02970019
- Acronym / sponsor ID
- CLR_16_27
- Conditions
- Parkinson Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sun Pharma Advanced Research Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2017 (actual)
- Primary completion
- 28 May 2019 (actual)
- Study completion
- 28 May 2019 (actual)
- First posted
- 21 Nov 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 is a safety, tolerability and pharmacokinetic study in subjects with Parkinson's disease
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| K0706 | Experimental | Drug: K0706K0706 will be administered once a day |
| Placebo | Experimental | Drug: PlaceboPlacebo will be administered once a day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Willing and able to give written, and dated, informed consent (or legally acceptable representative/impartial witness when applicable) and is available for the entire study
- Willing and able to comply with the scheduled visits, treatment plan, laboratory testing, study procedures, and restrictions (in the Investigator's opinion), and be accessible for follow-up
- Male or female aged 18 to 65 years (both inclusive)
- Diagnosed with Parkinson's disease
Key exclusion criteria (4 listed)
- Clinical diagnosis of genetic form of Parkinson's disease, or drug-induced parkinsonism
- Diagnosis of Parkinson's disease Dementia (probable, possible)
- Presence of severe dyskinesias
- History of brain surgery for Parkinson's disease
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 |
|---|---|---|
| K0706Once a day administration after fast | Drug | K0706 |
| PlaceboOnce a day administration after fast | Drug | Placebo |
Primary outcome
Adverse events
Time frame: 4 weeks
3 secondary outcomes
Peak plasma concentration
Time frame: 4 weeks
Area under the plasma concentration versus time curve
Time frame: 4 weeks
Time of observed peak plasma concentration
Time frame: 4 weeks
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 31 Mar 2020.
- Derived from this study: PubMed 40680102Joshi D, Kulkarni M, Parekh P, Shah S, Greig NH, Acharya S. Targeting protein kinases in Parkinson's disease: the emerging role of phytoconstituents. Nutr Neurosci. 2025 Dec;28(12):1532-1563. doi: 10.1080/1028415X.2025.2531356. Epub 2025 Jul 18.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing K0706 in people with Parkinson Disease, run by Sun Pharma Advanced Research Company Limited at 5 sites 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 4 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 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Adverse events (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02970019, which also lists 1 linked publication.
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 31 Mar 2020.