Safety Study of Larazotide Acetate to Treat Celiac Disease.

NCT00386165 | Completed Phase 1 FDA Drug

• 1 other identifier: CLIN1001-002
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Celiac Disease

Keywords

larazotide acetate

Outcome Measures

Primary Outcomes (3)

• Demonstrate the safety and tolerance of single doses of larazotide acetate in patients with controlled celiac disease on a gluten-free diet.

  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).

  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.

• 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

  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.

  erial blood samples were collected for pharmacokinetic determinations at baseline and 2 and 3 hours post dose.

• Evaluate the effects of single doses of larazotide acetate on intestinal permeability ratios and zonulin levels

  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.

  Intestinal permeability was measured each day following dosing. A gluten challenge was administered on Day 2.

Secondary Outcomes (2)

• Self-reported measures of GI discomfort

  Once daily on dosing days

• Patient Global Assessment of Disease Status

  At discharge from the clinic

Study Arms (2)

Larazotide acetate

EXPERIMENTAL

Larazotide acetate capsules: 12 mg QD x 3 days

Drug: larazotide acetate

Placebo

PLACEBO COMPARATOR

Placebo capsules: QD x 3 days

Drug: larazotide acetate

Interventions

larazotide acetate DRUG

larazotide acetate 4 mg capsules

Also known as: AT-1001, INN-202

Larazotide acetate; Placebo

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• 9 Meters Biopharma, Inc.: lead

Study Sites (1)

Parexel

Baltimore, Maryland, 21225, United States

Location

Related Publications (1)

• Paterson 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 RESULT

MeSH Terms

Conditions

Celiac Disease

Interventions

larazotide acetate

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Blake Paterson, MD

  Alba Therapeutics

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2006
• First Posted: October 11, 2006
• Study Start: November 29, 2005
• Primary Completion: January 26, 2006
• Study Completion: January 26, 2006
• Last Updated: September 11, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)