Oral Cyanocobalamin (Eligen B12) Bioavailability Study

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Emisphere Technologies, Inc.
• Treatments: Hydroxocobalamin; Vitamin B 12

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.