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

Parkinson Disease Clinical Trial

Official title:

A Double-blind, Placebo-controlled Study to Determine Safety, Tolerability, Pharmacokinetic of K0706.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02970019
• Other study ID #: CLR_16_27
• Status: Completed
• Phase: Phase 1
• Start date: March 30, 2017
• Est. completion date: May 28, 2019

Study information

• Verified date: March 2020
• Source: Sun Pharma Advanced Research Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 28, 2019
• Est. primary completion date: May 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• K0706
Once a day administration after fast
• Placebo
Once a day administration after fast

Locations

Country	Name	City	State
United States	SPARC Site 01	DeLand	Florida
United States	SPARC Site 03	Long Beach	California
United States	SPARC Site 02	Orlando	Florida
United States	SPARC Site 05	Panorama City	California
United States	SPARC Site 04	Raleigh	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Sun Pharma Advanced Research Company Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events		4 weeks
Secondary	Peak plasma concentration		4 weeks
Secondary	Area under the plasma concentration versus time curve		4 weeks
Secondary	Time of observed peak plasma concentration		4 weeks