Health Condition 1: E538- Deficiency of other specified B group vitamins
Conditions
Interventions
Intervention1: Methylcobalamin Nasal Spray, 250 mcg/spray/nostril: Part A: Part A of the study shall be conducted as monocentric, open-label,
multiple-dose, single-arm, clinical study in healthy subje
Sponsors
Torrent Pharamceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Part A Inclusion Criteria 1. Male or female subjects of 18-45 years of age 2. Subject voluntarily give written informed consent to participate in the study. Part B Inclusion Criteria 1. Male or female patients of 18-65 years of age 2. Patient with serum vitamin B12 levels 3. Patient voluntarily give written informed consent to participate in the study
Exclusion criteria
Exclusion criteria: Part A:Exclusion Criteria 1. Subject with a history of hypersensitivity to intranasal administration of vitamin B12 or its excipients or any intranasal preparations. 2. Subject who have taken any medication by intranasal route or have used any vitamin supplement within the past 72 hours prior to screening. 3. History of consumption of vitamin supplements i.e. as prescribed medication in the last 14 Days or over-the-counter medication/ herbal remedies in the last 7 Days prior to screening. Subjects currently on treatment with drugs, which interfere with folate or folic acid metabolism and serum vitamin B12 assay (e.g., cholestyramine, methotrexate, pyrimethamine, proton pump inhibitors, trimethoprim, etc.) 4. Subject with clinically significant abnormal nasal or respiratory tract conditions, for example, atrophic rhinitis, nasal polyp, upper respiratory tract infection etc. which may alter the absorption of the study investigational product. 5. Subject having any clinically significant medical illness that would compromise safety of the subject or study outcome/serum vitamin B12 levels as per investigator opinion 6. Subjects with liver enzymes (Alanine transaminase, Aspartate transaminase, Alkaline phosphatase) > 2.5X the upper limit of normal value (ULN) or total bilirubin >1.5X of ULN or serum creatinine >1.5X of ULN at screening and considered clinically significant by the investigator. 7. History of alcohol or drug abuse or tobacco sniffing. 8. Subjects with known cases of haemoglobinopathies (e.g history of thalessemia minor/major, sickle cell anemia etc.). 9. Subject with clinically abnormal findings on physical examination, vital signs, electrocardiogram and laboratoryinvestigations at screening 10. Subjects positive for Hepatitis B surface antigen (HBsAg),Hepatitis C antibody and human immunodeficiency virus (HIV)antibody test. 11. Subject with positive breath-alcohol test at enrolment. 12. Subject with positive opiate, tetrahydrocannabinol (THC),amphetamine, barbiturates, benzodiazepines or cocaine on urine test at enrolment or known active alcohol abuse within past 6 months 13. Pregnant or lactating women. 14. In the opinion of the investigator, subject is either unable to cooperate or unlikely to adhere with any study procedure 15. Subjects who have participated in any other investigational drug trial within the past 3 months prior to screening. Part B:Exclusion Criteria 1. Patients with a history of hypersensitivity to intranasal administration of vitamin B12 or its excipients or any intranasal preparations. 2. Patients who have taken any medication by intranasal route or have used any vitamin supplement within the past 72 hours prior to screening. 3. History of consumption of vitamin supplements i.e. as prescribed medication in the last 14 Days or over-the-counter medication/ herbal remedies in the last 7 Days prior to screening. Patients currently on treatment with drugs, which interfere with folate or folic acid metabolism and serum vitamin B12 assay (e.g., cholestyramine, methotrexate, pyrimethamine, proton pump inhibitors, trimethoprim, etc.) 4. Patients with clinically significant abnormal nasal or respiratory tract conditions, for example, atrophic rhinitis, nasal polyp,upper respiratory tract infection etc. which may al
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A: 1) To evaluate the safety and tolerability of methylcobalamin nasal spray in healthy subjects 2)To study serum concentration v/s time of methylcobalamin nasal spray to guide dosing in Part B Part B: 1) Proportion of patients achieving, serum vitamin B12 levels 200 pg/mL at Day 14Timepoint: Proportion of patients achieving, serum vitamin B12 levels more than 200 pg/mL at Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Methylmalonic acid (MMA) levels as compared to baseline at Day 7 and 14 in each treatment groupTimepoint: Day 7 and 14;Nasal sensory evaluation questionnaire score at Day 14Timepoint: Day 14;Part B:Proportion of patients maintaining serum vitamin B12 level 200 pg/mL at the end of 2 weeks of being on maintenance dose (Day 28) in each treatment group Timepoint: Day 28;Proportion of patients achieving serum vitamin B12 level 200 pg/mL at Day 21 in each treatment groupTimepoint: Day 21;Proportion of patients achieving serum vitamin B12 level 200 pg/mL at Day 7 in each treatment groupTimepoint: Day 7;Reticulocyte count and Reticulocyte Production Index (RPI) as compared to baseline at Day 7 and 14 in each treatment groupTimepoint: Day 7 and 14;Total amount of vitamin B12 excreted in urine over 12 hoursâ?? time after first doseTimepoint: 12 hoursâ?? time after first dose | — |
Countries
India
Contacts
Public ContactDr Sanjay Sharma
Torrent Pharmaceuticals Limited
Outcome results
None listed