Clinical trial NCT01311739: Oral Cyanocobalamin (Eligen B12) Bioavailability Study
Official title: An Open-label, Single-Dose, Parallel-Group, Randomized Study of Comparative Bioavailability of B12 After Oral Administration of B2 Formulated With an Absorption Promoter (SNAC), Oral B12 Alone and IV B12 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Pharmacokinetics
Lead sponsor: Emisphere Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2011-03-09
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess and compare the pharmacokinetics (PK) of cyanocobalamin after the oral administration of Eligen® 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 Eligen® B12 (cyanocobalamin/SNAC) versus oral cyanocobalamin alone and versus IV cyanocobalamin are also assessed.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects aged 18 to 45 years.
* Signed ICF prior to any study-related procedures.
* Normal organ function including renal and hepatic function.
* Normal hematological function.
* Body weight between 60 and 100 kg and within 18 - 30 kg/m2 for body mass index (BMI).
* Normal ranges in vital signs, ECG, and laboratory tests.
* Normal ranges of serum B12, methylmalonic acid (MMA), and homocysteine.

Exclusion Criteria:

* Current use (within 14 days) of acetaminophen or non-steroidal anti-inflammatory drugs (NSAIDs) (i.e., aspirin or ibuprofen)
* Current use (within 14 days) of antibiotics, antacids, multivitamins, or nutritional supplements.
* Absolute platelet count below 100 x 109/L
* History or current diagnosis of any clinically significant disease of the liver, kidneys or GI system, or any abnormal condition that compromises the function of these systems and could result in the possibility of altered absorption, excess accumulation, or impairment of metabolism or excretion of the study product.
* History or current diagnosis of any clinically significant hematological, immunological, metabolic, cardiovascular, neurological, or GI abnormalities which that should, in the opinion of the Investigator exclude the subject from this study.
* Any other clinically significant laboratory value at Screening, which, in the opinion of the Investigator, suggested a condition that could have precluded the subject from entering this study.
* At risk of transmitting infection via blood samples e.g., producing a positive HIV test at screening or having participated in a high-risk activity for contracting HIV; producing a positive HBsAg test at screening; producing a positive hepatitis C antibody test at screening.
* Participation in a clinical research study involving a new chemical entity within 30 days of study entry.
* Significant loss or donation of blood within 56 days or plasma within 30 days prior to the initial dose in this study.
* Unsuitable for any reason to receive study product in the opinion of the Investigator.
* Alcohol consumption within the last 48 hours prior to study entry or anytime during the study.
* Positive urine alcohol test.

Primary outcomes:
measure: Serum Cobalamin Pharmacokinetics (PK)
timeFrame: pre-dose to 24 hours post-dose
Secondary outcomes:
measure: Number of Subjects with Adverse Events as a Measure of Safety and Tolerability
timeFrame: pre-dose to 24 (end-of-study) hours postdose
Other outcomes:
Locations:
Study officials:
affiliation: MDS Pharma Services
name: Sandra M. Connolly, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.