Safety and Tolerability Study of K0706 in Subjects With P... | NCT02970019

Studies
Safety and Tolerability Study of K0706 in Subjects With Parkinson's Disease

NCT02970019

Sponsor

Sun Pharma Advanced Research Company Limited

Status

Completed

Last Update Posted

Mar 31, 2020Actual

Enrollment

60Actual

Phase

Phase 1

Conditions

Parkinson Disease

Interventions

K0706
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 30, 2017Actual

Primary Completion Date

May 28, 2019Actual

Completion Date

May 28, 2019Actual

First Submitted Date

Nov 18, 2016

First Submission Date that Met QC Criteria

Nov 18, 2016

First Posted Date

Nov 21, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 29, 2020

Last Update Posted Date

Mar 31, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
K0706	Experimental	K0706 will be administered once a day	Drug: K0706
Placebo	Experimental	Placebo will be administered once a day	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
K0706	Drug	Once a day administration after fast	K0706
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse events		4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Peak plasma concentration		4 weeks
Area under the plasma concentration versus time curve		4 weeks
Time of observed peak plasma concentration

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SPARC Site 03		Long Beach	California	90806	United States
SPARC Site 05

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40680102	Derived	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.

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases