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

Phase 1

Completed

• Conditions: Parkinson Disease
• Interventions: Drug: Placebo; Drug: K0706

• Registration Number: NCT02970019
• Lead Sponsor: Sun Pharma Advanced Research Company Limited

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-18
• Study First Submitted QC: 2016-11-18
• Study First Posted: 2016-11-21
• Study Start: 2017-03-30
• Primary Completion: 2019-05-28
• Study Completion: 2019-05-28
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-29
• Last Update Posted: 2020-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo will be administered once a day
K0706	K0706	K0706 will be administered once a day

Primary Outcome Measures

Name	Time	Method
Adverse events	4 weeks

Secondary Outcome Measures

Name	Time	Method
Time of observed peak plasma concentration	4 weeks
Peak plasma concentration	4 weeks
Area under the plasma concentration versus time curve	4 weeks

Trial Locations

Locations (5)

SPARC Site 04; 🇺🇸 Raleigh, North Carolina, United States

SPARC Site 05; 🇺🇸 Panorama City, California, United States

SPARC Site 01; 🇺🇸 DeLand, Florida, United States

SPARC Site 02; 🇺🇸 Orlando, Florida, United States

SPARC Site 03; 🇺🇸 Long Beach, California, United States