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

Phase 1

Completed

• Conditions: Health Condition 1: G20- Parkinsons disease

• Registration Number: CTRI/2019/12/022395
• Lead Sponsor: Kashiv BioScience LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-03-20
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 32

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. Currently being treated with a stable regimen for at least 4 weeks prior to enrollment of anti-parkinsonian drugs which include at least one LD-containing therapy with or without dopamine agonist at Screening

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

6. Must have predictable fluctuations between ON and OFF states

7. Modified Hoehn and Yahr stages 1 to 4 in ON state

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

9. Mini Mental State Examination MMSE >= 24 at screening

Visit.

10. Women of child bearing potential, defined as women physiologically capable of becoming pregnant, unless they are using effective method of contraception during dosing of the investigational product practicing two acceptable methods of contraception.

Acceptable methods of contraception are

Oral or parenteral injection, patch or implant hormonal contraception which has been used continuously for at least one month prior to the first dose of study medication

Intrauterine device IUD or intrauterine system IUD and IUS

Double barrier method of contraception Condom and occlusive cap or condom and spermicidal agent

Male sterilization at least 6 months prior to the screening, should be the sole male partner for that patient

Female sterilization surgical bilateral oophorectomy or tubal ligation within at least 6 weeks prior to study participation

Total abstinence, partial abstinence is not acceptable

Female patients with negative serum pregnancy test at screening and negative urine pregnancy test on the day of hospitalization only for female who has not completed 1 year after menopause & have not gone through hysterectomy or bilateral tubal ligation

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

Exclusion Criteria

1. Lactating women

2. Diagnosed with atypical Parkinsonism

3. PD patients having severe uncontrolled symptoms of anxiety and or depression with or without suicidal tendencies which may require any antidepressants

4. History, physical findings or laboratory results suggesting any other diagnosis other than PD.

5. Allergic or nonresponsive to previous CDLD therapy

6. Known hypersensitivity to Carbidopa and Levodopa or any of the components of investigational product

7. Patients with narrow angle-glaucoma

8. Patients with suspicious, undiagnosed skin lesions or history of melanoma

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

10. Patient with implanted metal device like pacemaker, heart valve, stent, implantable cardioverter defibrillator or any artificial joints only applicable for cohort 4

11. History of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias that are not controlled with medical and or surgical interventions

A recent <= 12 months history of myocardial infarction with secondary arrhythmias is exclusionary regardless of the therapeutic control

12. Any medical Example liver or kidney impairment, peptic ulcer or condition or history that, in the Investigators opinion may jeopardize the patients safety

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

14. Blood loss of >= 350 mL 1 unit within 90 days before the first dose of investigational product

15. had prior functional neurosurgical treatment for PD ablation or Deep Brain Stimulation

16. 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, 0.33 hours, 0.50 hours, 0.75 hours, 1.00 hour, 1.33 hours, 1.67 hours, 2.00 hours, 2.50 hours, 3.00 hours, 4.00 hours, 5.00 hours, 6.00 hours, 7.00 hours, 8.00 hours, 9.00 hours, 10.00 hours, 11.00 hours, 12.00 hours, 13.00hours, 14.00 hours, 16.00 hours, 20.00 hours (± 02 minutes), Day-2 : 24.00 hours (± 02 minutes)

Secondary Outcome Measures

Name	Time	Method
To track the location of the tablet in the body after single dose administration. <br/ ><br>To assess safety of K102 at all strengths <br/ ><br>Timepoint: Day- 1 : 4.00, 12.00, 16.00, Day-2 : 24.00 and 48.00 hours (±60 minutes) post-dose