Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess and compare the pharmacokinetics (PK) of cyanocobalamin after the oral administration of EligenĀ® B12 (cyanocobalamin/SNAC), oral cyanocobalamin alone (commercially-available formulation) and cyanocobalamin administered intravenously (IV) (also a commercially-available formulation) to healthy male subjects under fasting conditions. The safety and tolerability of oral EligenĀ® B12 (cyanocobalamin/SNAC) versus oral cyanocobalamin alone and versus IV cyanocobalamin are also assessed.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10 mg EligenĀ® B12 (Cyanocobalamin/SNAC) | Experimental | A single oral dose of EligenĀ® B12, cyanocobalamin/SNAC (5 mg cyanocobalamin/100 mg SNAC) administered in the fasted state as 2 tablets taken with 50 mL of water resulting in a total dose of 10 mg cyanocobalamin and 200 mg SNAC. |
|
| 5 mg EligenĀ® B12 (Cyanocobalamin/SNAC) | Experimental | A single oral dose of EligenĀ® B12, cyanocobalamin/SNAC (5 mg cyanocobalamin/100 mg SNAC) administered in the fasted state as a tablet taken with 50 mL of water resulting in a total dose of 5 mg cyanocobalamin and 100 mg SNAC. |
|
| 5 mg Oral Cyanocobalamin | Active Comparator | A single oral dose of cyanocobalamin alone (5 mg cyanocobalamin, commercial: VITALABS, INC) administered in the fasted state as a tablet taken with 50 mL of water resulting in a total dose of 5 mg cyanocobalamin. |
|
| 1 mg Intravenous Cyanocobalamin | Active Comparator | A single intravenous (IV) dose of cyanocobalamin (1 mg cyanocobalamin) administered in the fasted state. Each subject will receive a 1 mL IV injection of a 1 mg/mL (1000 μg/mL) solution resulting in a total dose of 1 mg cyanocobalamin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyanocobalamin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum Cobalamin Pharmacokinetics (PK) | Serum cobalamin evaluated via collection and processing of blood samples from predose through 24 hours. Pharmacokinetics to be determined by non-compartmental analysis using predose to 24 hour serum cyanocobalamin non-baseline-adjusted and baseline-adjusted concentration data. Serum cobalamin PK parameters to include: Cmax, tmax, AUClast, AUCā, t1/2, and Kel and bioavailability (% F) of oral formulations. | pre-dose to 24 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects with Adverse Events as a Measure of Safety and Tolerability | Safety evaluated through the monitoring of medical history findings, physical examination findings, concomitant medications, vital signs (including blood pressure, respiratory rate, heart rate, and temperature), laboratory tests (hematology, serum chemistry, and urinalysis values), ECGs, AEs, and serious adverse events (SAEs). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sandra M. Connolly, MD | MDS Pharma Services | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21722960 | Derived | Castelli MC, Wong DF, Friedman K, Riley MG. Pharmacokinetics of oral cyanocobalamin formulated with sodium N-[8-(2-hydroxybenzoyl)amino]caprylate (SNAC): an open-label, randomized, single-dose, parallel-group study in healthy male subjects. Clin Ther. 2011 Jul;33(7):934-45. doi: 10.1016/j.clinthera.2011.05.088. Epub 2011 Jul 1. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014805 | Vitamin B 12 |
| ID | Term |
|---|---|
| D045728 | Corrinoids |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| pre-dose to 24 (end-of-study) hours postdose |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |