Safety Study of AT1001 to Treat Celiac Disease.
Information source: Alba Therapeutics
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Celiac Disease
Intervention: AT-1001 (Drug)
Phase: Phase 1
Sponsored by: Alba Therapeutics
Official(s) and/or principal investigator(s):
Blake Paterson, MD, Study Chair, Affiliation: Alba Therapeutics
To demonstrate the safety and tolerance of single, oral doses of AT-1001 in celiac disease
subjects that are gluten-free diets and in remission.
Official title: A Phase Ib, Randomized, Double-Blind, Placebo Controlled Study to Determine the Safety, Tolerance, Pharmacokinetic and Pharmacodynamic Effects of Single Doses of AT-1001 in Celiac Disease Subjects.
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety Study
To demonstrate the safety and tolerance of single, oral doses of AT-1001 in celiac disease subjects that are gluten-free and in remission
To determine whether quantifiable AT-1001 concentrations are present in plasma following single oral doses and to characterize the pharmacokinetic behavior of AT-1001 in celiac disease subjects that are gluten-free and in remission
To evaluate the effects of single doses of AT-1001 on intestinal permeability ratios and zonulin levels following single, oral challenge doses of gluten (2.5 gm) by utilizing urinary lactulose and mannitol, and serum zonulin concentrations as biomarkers.
Self-reported measures of GI discomfort
One (1) cohort of 24 (2: 1 drug: placebo) subjects will receive single oral doses of either
AT-1001 or matching placebo. Subjects will complete screening and thereafter be admitted to
the clinic prior to treatment. On Day 1 AT-1001 or matching placebo will be administered
followed by a baseline intestinal permeability test. Intestinal permeability will be
measured by administration of an oral sucrose, lactulose and mannitol solution followed by an
8-hour urine collection. Day 2 subjects will be given AT-1001 or matching placebo followed
by a gluten challenge and have the intestinal permeability test repeated. Day 3 subjects
will be administered AT-1001 or matching placebo followed by a post gluten challenge
intestinal permeability test. Serial blood samples will be collected for pharmacokinetic
determinations at baseline, 2, and 3 hours post administration of AT-1001 or matching
placebo, for zonulin determinations at baseline (prior to first dose) and at 3 hours post
dose, and for cytokine determination at baseline, 3 hours post dose (Days 2 and 3 only) and
Day 7. Sucrose, lactulose, mannitol, zonulin and AT-1001 concentrations will be determined
by validated analytical methods.
Subjects will be evaluated at screening (medical history, physical examination, vital signs,
clinical laboratory testing, and 12-lead electrocardiogram). Vital signs and clinical
laboratory testing will be conducted pre-dose and vital signs, clinical laboratory testing
and EKG will be monitored post dose. Adverse event reports will be monitored throughout the
study. At the end of the study a physical exam and clinical laboratory testing will be
Minimum age: 18 Years.
Maximum age: 59 Years.
- Subject must have been diagnosed with celiac disease by biopsy for ≥ 6 months
(attending physician confirmation will be accepted in lieu of a biopsy report).
- Subject must be on a gluten-free diet for at least the past 6 months.
- Subject has Anti-Tissue Transglutaminase (tTG) > 10 EU as measured by serology
- Subject intermittently consumes clinically significant quantities of non-steroidal
anti-inflammatory agents (“NSAIDs”) and proton-pump inhibitors, within the last 3 days
prior to the treatment visit.
Locations and Contacts
Parexel, Baltimore, Maryland 21225, United States
Starting date: January 2006
Ending date: February 2006
Last updated: October 10, 2006