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Trial · Interventional

CompletedPhase 1Registry data

Safety Study of Larazotide Acetate to Treat Celiac Disease.

NCTNCT00386165 (opens ClinicalTrials.gov in a new tab)Other idCLIN1001-002
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Overview

Status
Completed
Phase
Phase 1
Enrollment
21 participants (actual)
Sponsor
9 Meters Biopharma, Inc. · Industry
Design
Randomized · Double masking
Countries
1 country

United States

Start
29 Nov 2005
Primary completion
26 Jan 2006
Completion
26 Jan 2006
First posted
11 Oct 2006 (estimated)
Last update posted
11 Sept 2017
Conditions
Celiac Disease

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200520062007
  1. Ph 1

    Safety Study of Larazotide Acetate to Treat Celiac Disease.

    NCT00386165

    29 Nov 2005 to 26 Jan 2006

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • larazotide acetateDrug

Arms2

  • Experimental

    Larazotide acetate

    Larazotide acetate capsules: 12 mg QD x 3 days

  • Placebo comparator

    Placebo

    Placebo capsules: QD x 3 days

Primary outcomes3

Outcomes the sponsor listed as primary.

  1. 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.

    Registry description

    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).

  2. 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.

    Registry description

    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.

  3. 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.

    Registry description

    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 outcomes(2)

  1. Self-reported measures of GI discomfort

    Time frame · Once daily on dosing days

    Registry description

    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.

  2. Patient Global Assessment of Disease Status

    Time frame · At discharge from the clinic

    Registry description

    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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultPaterson BM, Lammers KM, Arrieta MC, Fasano A, Meddings JB. The safety, tolerance, pharmacokinetic and pharmacodynamic effects of single doses of AT-1001 in coeliac disease subjects: a proof of concept study. Aliment Pharmacol Ther. 2007 Sep 1;26(5):757-66. doi: 10.1111/j.1365-2036.2007.03413.x. PMID 17697209

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 59 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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