Health Condition 1: G20- Parkinsons disease
Conditions
Interventions
Intervention1: K102(CD/LD) of Kashiv BioSciences, USA: 72.5/290 mg in extended release tablets (low strength)- Single oral dose (1 Tablet)
Intervention2: K102(CD/LD) of Kashiv BioSciences, USA: 92.5/3
Sponsors
Kashiv BioScience LLC
CBCC Global Research LLP
Eligibility
Inclusion criteria
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
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. 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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| To track the location of the tablet in the body after single dose administration. To assess safety of K102 at all strengths Timepoint: Day- 1 : 4.00, 12.00, 16.00, Day-2 : 24.00 and 48.00 hours (±60 minutes) post-dose | — |
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
India
Contacts
Public ContactDr Prayag Shah
Kashiv BioSciences LLC
Outcome results
None listed