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

• Sponsor: Sun Pharma Advanced Research Company Limited (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02970019
• Collaborator: (none)
• Enrollment: 60
• Locations: 5
• Arms: 2
• Actual Duration (Months): 25.9
• Patients Per Site: 12
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

This is a safety, tolerability and pharmacokinetic study in subjects with Parkinson's disease

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Drug: K0706; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Double-blind, Placebo-controlled Study to Determine Safety, Tolerability, Pharmacokinetic of K0706.
• Actual Study Start Date: Mar 30, 2017
• Actual Primary Completion Date: May 28, 2019
• Actual Study Completion Date: May 28, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: K0706 K0706 will be administered once a day	Drug: K0706; Once a day administration after fast
Experimental: Placebo Placebo will be administered once a day	Drug: Placebo; Once a day administration after fast

Outcome Measures

Primary Outcome Measures

1. Adverse events [4 weeks]

Secondary Outcome Measures

1. Peak plasma concentration [4 weeks]

2. Area under the plasma concentration versus time curve [4 weeks]

3. Time of observed peak plasma concentration [4 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. 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

2. 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

3. Male or female aged 18 to 65 years (both inclusive)

4. Diagnosed with Parkinson's disease

Exclusion Criteria:

1. Clinical diagnosis of genetic form of Parkinson's disease, or drug-induced parkinsonism

2. Diagnosis of Parkinson's disease Dementia (probable, possible)

3. Presence of severe dyskinesias

4. History of brain surgery for Parkinson's disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SPARC Site 03	Long Beach	California	United States	90806
2	SPARC Site 05	Panorama City	California	United States	91402
3	SPARC Site 01	DeLand	Florida	United States	32720
4	SPARC Site 02	Orlando	Florida	United States	32806
5	SPARC Site 04	Raleigh	North Carolina	United States	27612

Sponsors and Collaborators

• Sun Pharma Advanced Research Company Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sun Pharma Advanced Research Company Limited
• ClinicalTrials.gov Identifier: NCT02970019
• Other Study ID Numbers: CLR_16_27
• First Posted: Nov 21, 2016
• Last Update Posted: Mar 31, 2020
• Last Verified: Mar 1, 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Parkinson Disease

Study Results

No Results Posted as of Mar 31, 2020