Trial record 2 of 7 for:    "alba therapeutics"

Safety Study of AT1001 to Treat Celiac Disease.

This study has been completed.
Sponsor:
Information provided by:
Alba Therapeutics
ClinicalTrials.gov Identifier:
NCT00386165
First received: October 9, 2006
Last updated: October 10, 2006
Last verified: October 2006
  Purpose

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.


Condition Intervention Phase
Celiac Disease
Drug: AT-1001
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Alba Therapeutics:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • Self-reported measures of GI discomfort
  • Pharmacokinetic Measures
  • Pharmacodynamic Measures

Estimated Enrollment: 24
Study Start Date: January 2006
Estimated Study Completion Date: February 2006
Detailed Description:

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 performed.

  Eligibility

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00386165

Locations
United States, Maryland
Parexel
Baltimore, Maryland, United States, 21225
Sponsors and Collaborators
Alba Therapeutics
Investigators
Study Chair: Blake Paterson, MD Alba Therapeutics
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00386165     History of Changes
Other Study ID Numbers: CLIN1001-002
Study First Received: October 9, 2006
Last Updated: October 10, 2006
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on August 01, 2014