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Safety Study of Larazotide Acetate to Treat Celiac Disease.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00386165
First Posted: October 11, 2006
Last Update Posted: September 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Innovate Biopharmaceuticals
  Purpose
To demonstrate the safety, pharmacokinetics and efficacy of larazotide acetate in patients with controlled celiac disease on a gluten-free diet following a gluten challenge.

Condition Intervention Phase
Celiac Disease Drug: larazotide acetate Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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 Larazotide Acetate (AT-1001) in Celiac Disease Subjects.

Resource links provided by NLM:


Further study details as provided by Innovate Biopharmaceuticals:

Primary Outcome Measures:
  • Demonstrate the safety and tolerance of single doses of larazotide acetate in patients with controlled celiac disease on a gluten-free diet. [ Time Frame: AEs were monitored throughout the study. Clinical laboratory testing was performed at scheduled times throughout the study. ECGs were measured at baseline, 3 hours post-dose on all study days and at the follow-up visit. ]
    Safety assessments included scheduled monitoring of adverse events (AEs), vital sign measurements, 12-lead ECG measurements, physical examinations, and clinical laboratory testing (chemistry, hematology, and urinalysis).

  • Determine whether quantifiable concentrations of larazotide acetate are present in plasma following single oral doses and to characterize the pharmacokinetic behavior of larazotide acetate in celiac disease subjects that are gluten-free and in remission [ Time Frame: erial blood samples were collected for pharmacokinetic determinations at baseline and 2 and 3 hours post dose. ]
    Pharmacokinetic samples were taken to determine whether quantifiable concentrations of larazotide acetate were present in plasma following single oral doses and to characterize the pharmacokinetic behavior of larazotide acetate in celiac disease subjects.

  • Evaluate the effects of single doses of larazotide acetate on intestinal permeability ratios and zonulin levels [ Time Frame: Intestinal permeability was measured each day following dosing. A gluten challenge was administered on Day 2. ]
    Intestinal permeability was measured by administration of an oral sucrose, lactulose and mannitol solution followed by urine and serum collection to measure urinary lactulose and mannitol, and serum zonulin concentrations as biomarkers.


Secondary Outcome Measures:
  • Self-reported measures of GI discomfort [ Time Frame: Once daily on dosing days ]
    GI discomfort was reported by marking an "X" on a 10 cm linear line. Other GI Symptoms were assessed by subjects answering three questions related to bowel function.

  • Patient Global Assessment of Disease Status [ Time Frame: At discharge from the clinic ]
    Subjects chose one of seven ordinal levels in response to a question related to any change in their disease status since being admitted to the clinic


Enrollment: 21
Actual Study Start Date: November 29, 2005
Study Completion Date: January 26, 2006
Primary Completion Date: January 26, 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Larazotide acetate
Larazotide acetate capsules: 12 mg QD x 3 days
Drug: larazotide acetate
larazotide acetate 4 mg capsules
Other Names:
  • AT-1001
  • INN-202
Placebo Comparator: Placebo
Placebo capsules: QD x 3 days
Drug: larazotide acetate
larazotide acetate 4 mg capsules
Other Names:
  • AT-1001
  • INN-202

Detailed Description:
CLIN1001-002 was a Phase 1b, randomized, double-blind, placebo controlled study to determine the safety, tolerance, pharmacokinetic and pharmacodynamic effects of single doses of larazotide acetate in subjects with celiac disease subjects. Study subjects were randomized (2:1) to receive single oral doses of larazotide acetate 12 mg or matching placebo once daily for 3 days. Subjects received a single-blinded gluten challenge (5 mg amygluten) on Day 2. Intestinal permeability was measured each day following dosing. Intestinal permeability was measured by administration of an oral sucrose, lactulose and mannitol solution followed by a 6-hour urine collection. Serial blood samples were collected for pharmacokinetic determinations at baseline and 2 and 3 hours post dose; for zonulin determinations at baseline (prior to first dose) and 3 hours post dose; and for cytokine determination at baseline and 3 hours post dose (Days 2 and 3 only) and on Day 7. Sucrose, lactulose, mannitol, zonulin and larazotide acetate concentrations were determined by validated analytical methods.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00386165


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

Publications:
Responsible Party: Innovate Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT00386165     History of Changes
Other Study ID Numbers: CLIN1001-002
First Submitted: October 9, 2006
First Posted: October 11, 2006
Last Update Posted: September 11, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Innovate Biopharmaceuticals:
larazotide acetate

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


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