A study of K102(Medicine) in patients with Parkinsonâ??s disease

Phase 1

Completed

• Conditions: Health Condition 1: G20- Parkinsons disease

• Registration Number: CTRI/2019/09/021093
• Lead Sponsor: Kashiv Biosciences LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-12-06
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 16

Inclusion Criteria

1. Able to provide informed consent.

2. Able and willing to comply with the protocol, including availability for all scheduled study visits and blood sample collections.

3. Aged 35 to 70, both inclusive, with a diagnosis of PD, currently being treated with a stable regimen (at least 4 weeks) of anti-parkinsonian drugs which include at least 1 LD-containing therapy with or without dopamine agonist at Screening.

4. A diagnosis of PD for 10 years or less at Screening.

5. Must have predictable fluctuations between â??ONâ?? and â??OFFâ?? states.

6. Modified Hoehn and Yahr stages 1 to 4 in â??ONâ?? state.

7. Male or Female age 30 years or older at time of PD diagnosis.

8. Mini Mental State Examination (MMSE) >= 24 at screening

visit.

9. Patients who agree to use adequate contraception (e.g., hormonal, chemical, double-barrier, or abstinence) while in the study.

10. Female patients with negative serum pregnancy test at screening and negative urine pregnancy test on the day of hospitalization.

11. No history of addiction to any recreational drug or drug dependence or alcohol addiction.

Exclusion Criteria

1. Breastfeeding.

2. Diagnosed with atypical parkinsonism.

3. History, physical findings or laboratory results suggesting a diagnosis other than PD.

4. Allergic or nonresponsive to previous CD-LD therapy.

5. Known hypersensitivity to Carbidopa, Levodopa or any of the components of investigational product.

6. Patients with narrow angle-glaucoma.

7. Patients with suspicious, undiagnosed skin lesion or history of melanoma.

8. Patients scheduled to receive non-selective MAOIs or other prohibited medications.

9. Any medical (e.g., liver or kidney impairment, peptic ulcer) or condition/history that, in the Investigators opinion, may jeopardize the patients safety.

10. Exposure to any investigational agent within 30 days prior to first dose of investigational product.

11. Donated blood or plasma within 30 days before the first dose of investigational product.

12. Had prior functional neurosurgical treatment for PD (ablation or Deep Brain Stimulation).

13. Patients with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the pharmacokinetics and dose proportionality of single dose of K102 in PD patients.Timepoint: Day 1: Pre-dose blood sample (00.00) within 1.00 hour prior to dosing, 1 hr, 1.5 hr, 2 hr, 2.5 hr, 3 hr, 4 hr, 5 hr, 6 hr, 7 hr, 8 hr, 9 hr, 10 hr, 11 hr, 12 hr, 14 hr, 16 hr, 18 hr, 20 hr (± 05 minutes), Day 2: 24 hr (± 05 minutes)

Secondary Outcome Measures

Name	Time	Method
Individual patient safety of K102 will also be evaluated in PD patients.Timepoint: Day 1: Pre-dose blood sample (00.00) within <br/ ><br>1.00 hour prior to dosing, 1 hr, 1.5 hr, 2 hr, 2.5 <br/ ><br>hr, 3 hr, 4 hr, 5 hr, 6 hr, 7 hr, 8 hr, 9 hr, 10 hr, 11 <br/ ><br>hr, 12 hr, 14 hr, 16 hr, 18 hr, 20 hr (± 05 <br/ ><br>minutes), Day 2: 24 hr (± 05 minutes)