Safety Study of Larazotide Acetate to Treat Celiac Disease.

NCT ID: NCT00386165

Last Updated: 2017-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-29
• Study Completion Date: 2006-01-26

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.

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.

Conditions

Celiac Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Larazotide acetate

Larazotide acetate capsules: 12 mg QD x 3 days

Group Type: EXPERIMENTAL

larazotide acetate

Intervention Type: DRUG

larazotide acetate 4 mg capsules

Placebo

Placebo capsules: QD x 3 days

Group Type: PLACEBO_COMPARATOR

larazotide acetate

Intervention Type: DRUG

larazotide acetate 4 mg capsules

Interventions

larazotide acetate

larazotide acetate 4 mg capsules

Intervention Type: DRUG

Other Intervention Names

AT-1001; INN-202

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

9 Meters Biopharma, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Blake Paterson, MD

Role: STUDY_CHAIR

Alba Therapeutics

Locations

Parexel

Baltimore, Maryland, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 17697209 (View on PubMed)

Other Identifiers

CLIN1001-002

Identifier Type: -

Identifier Source: org_study_id