Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2026-01-14 @ 2:24 PM
Study NCT ID:
NCT02999620
Status:
COMPLETED
Last Update Posted:
2017-08-11
First Post:
2016-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FBCx (Alpha-CD) Mechanism of Action Trial
Sponsor:
SFI Research
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FMAT
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: