HealthyNCT01311739
Oral Cyanocobalamin (Eligen B12) Bioavailability Study
A study testing Cyanocobalamin in people with Healthy, run by Emisphere Technologies, Inc..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Cyanocobalamin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- May 2008to Jun 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this 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
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.
- Conditions
- Healthy
- Being tested
- Cyanocobalamin
- Keywords
- Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyanocobalaminDrug
Also called B12, Eligen® B12, Cobalamin
| Study group | Role | What they receive |
|---|---|---|
| 10 mg Eligen® B12 (Cyanocobalamin/SNAC) | Experimental | A single oral dose of Eligen® 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. Receives: Drug: Cyanocobalamin |
| 5 mg Eligen® B12 (Cyanocobalamin/SNAC) | Experimental | A single oral dose of Eligen® 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. Receives: Drug: Cyanocobalamin |
| 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. Receives: Drug: 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. Receives: Drug: Cyanocobalamin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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, AUC∞, t1/2, and Kel and bioavailability (% F) of oral formulations.
Measured: pre-dose to 24 hours post-dose
Secondary outcomes (1)
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).
Measured: pre-dose to 24 (end-of-study) hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2011 (estimated)
- Study startMay 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emisphere Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Sandra M. Connolly, MD, Principal investigator, MDS Pharma Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01311739
- Sponsor's protocol ID
- EMIS 112-C-01
- Status last verified
- Mar 2011
- First submitted
- 8 Mar 2011
- Last updated
- 9 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21722960
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01311739
- Acronym / sponsor ID
- EMIS 112-C-01
- Conditions
- Healthy
- Keywords
- Pharmacokinetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Emisphere Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2008
- Study completion
- Jun 2008 (actual)
- First posted
- 9 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 10 mg Eligen® B12 (Cyanocobalamin/SNAC) | Experimental | Drug: CyanocobalaminA single oral dose of Eligen® 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 Eligen® B12 (Cyanocobalamin/SNAC) | Experimental | Drug: CyanocobalaminA single oral dose of Eligen® 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 | Drug: CyanocobalaminA 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 | Drug: CyanocobalaminA 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CyanocobalaminAlso: B12, Eligen® B12, Cobalamin | Drug | 1 mg Intravenous Cyanocobalamin, 10 mg Eligen® B12 (Cyanocobalamin/SNAC), 5 mg Eligen® B12 (Cyanocobalamin/SNAC), 5 mg Oral Cyanocobalamin |
Primary outcome
Serum Cobalamin Pharmacokinetics (PK)
Time frame: pre-dose to 24 hours post-dose
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, AUC∞, t1/2, and Kel and bioavailability (% F) of oral formulations.
1 secondary outcome
Number of Subjects with Adverse Events as a Measure of Safety and Tolerability
Time frame: pre-dose to 24 (end-of-study) hours postdose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2011.
- Derived from this study: PubMed 21722960Castelli 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra M. Connolly, MD principal investigator
MDS Pharma Services
Questions about this trial
What is this clinical trial studying?
A study testing Cyanocobalamin in people with Healthy, run by Emisphere Technologies, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Cobalamin Pharmacokinetics (PK) (time frame: pre-dose to 24 hours post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01311739, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2011.