FBCx (Alpha-CD) Mechanism of Action Trial

A Single Center, Randomized, Double-blind, Placebo Controlled, Two-way Crossover Study to Determine the Fat Losses in Stool Associated With Alpha-CD Use as Compared to Placebo Using a Radiotracer

To determine the fat losses in stool associated with alpha-CD use in healthy volunteers, as compared to placebo when consumed with a standardized radiolabeled fatty meal.

This clinical investigation will determine the fat losses in stool associated with alpha-CD use as compared to placebo when ingested with a standardized liquid breakfast (100 microCi of [3H]triolein) and 20 microCi of [14C]tripalmitin). The ingested dose will be 2 g of α-CD at each of three meals per day for 2 days.

Eight subjects will be recruited in a two-way crossover design consisting of two treatment periods.

Treatment 1 requires all subjects to receive α-CD and a meal containing the fatty acid radiotracers Treatment 2 requires all subjects to receive placebo and a meal containing the fatty acid radiotracers All subjects will be observed for 48 hours as an in-patient, and a further 24 hours as an out-patient following the meal containing the radiotracer and will then undergo at least a further ≥ 14 day washout period before crossing over to the alternate treatment.

All subjects randomized to the α-CD treatment arm will receive 2 g of α-CD (2 x 1 g tablets), at each of three meals per day for 2 days. During the placebo phase, all subjects will receive two identical-looking placebo tablets.

Inclusion Criteria:

• Healthy weight stable individuals (defined as a BMI of ≥18.5 and <27, and stable for at least the preceding two months from Screening)
• Not pregnant, and if of childbearing potential, agrees to use adequate birth control (hormonal or barrier method of birth control or abstinence) prior to study entry and during the trial and agrees not to donate sperm or ova, for the duration of the study
• Subjects ≥ 18 - ≤60 years of age at screening
• Consistent regular bowel movement (defined as between 3 times a day to 1 time per day)
• Provide Informed Consent
• Willing and able to complete study procedures within the study timelines
• Adequate renal function: serum creatinine less than 1.5 x upper limit of normal (ULN)
• Adequate liver function: serum glutamic oxaloacetic transaminase/aspartate aminotransferase (SGOT/AST) and serum glutamic pyruvic transaminase/alanine aminotransferase (SGPT/ALT) ≤ 2 × ULN and serum bilirubin ≤ 1.5 × ULN unless Gilbert's syndrome has previously been confirmed for the subject
• Adequate bone marrow function: white blood cells (WBCs) ≥ 3,000/mm3, absolute neutrophil count (ANC) ≥ 1,500/mm3, hemoglobin ≥ 9 g/dL, and platelets ≥ 100,000/mm3

Exclusion Criteria:

• Evidence of chronic pancreatitis
• Evidence of irritable bowel syndrome (medical or self-diagnosed)
• Previous gallbladder surgery
• Use of enemas and/or suppositories within 30 days of Screening
• Consuming ≥ 375 mg of caffeine per day (equivalent to 5 serves of 1 oz. restaurant style espresso per day)
• History of febrile illness within 5 days prior to Screening
• Evidence or history of substance or alcohol abuse
• History of major depression (per DSM4 criteria), bipolar disorder, or schizophrenia
• Current use of prescription or non-prescription weight loss products (≥ 2 week washout period is required to become eligible)
• Smoking ≥ 30 cigarettes (one pack) per week
• Significant dietary restrictions (incl. vegan, vegetarian diets and any subject not prepared to consume any of the standardized food/s
• Evidence of an active eating disorder (incl. anorexia nervosa, bulimia, and/or obsessive compulsive disorders)
• Use of other investigational agent(s) at the time of enrollment, or within 30 days or five half-lives of enrollment, whichever is longer
• Pregnant or lactating
• Current use of any medication known to affect gut motility
• History of malignancy, treated or untreated, within the past five years, with the exception of non-melanoma skin cancer and cervical carcinoma in situ
• A known history of hypersensitivity to any of the α-CD components
• Any other health condition that would preclude participation in the study in the judgment of the principal investigator