NCT00386165

Safety Study of Larazotide Acetate to Treat Celiac Disease.

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: 9 Meters Biopharma, Inc. · Industry
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	larazotide acetate	larazotide acetate 4 mg capsules

Timeline

• Start date: 2005-11-29
• Primary completion: 2006-01-26
• Completion: 2006-01-26
• First posted: 2006-10-11
• Last updated: 2017-09-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study