Safety of Larazotide Acetate in Healthy Volunteers

A Phase 1, Randomized, Double-Blind, Placebo Controlled, Multi-Dose Study to Determine the Safety, Tolerance and Pharmacokinetics of 3 Dose Levels of Larazotide Acetate (AT-1001) in Healthy Volunteers

To demonstrate the safety, tolerance and pharmacokinetics of multiple, oral doses of larazotide acetate.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: larazotide acetate

Detailed Description

CLIN1001-003 was a Phase 1, randomized, double-blind, placebo controlled multi-dose study to determine the safety, tolerance, and pharmacokinetics (including food effect) of 3 dose levels of larazotide acetate in healthy volunteers. Three (3) cohorts of 8 subjects, in which six (6) subjects in each cohort received larazotide acetate in escalating doses of 0.25 mg, 1 mg, or 4 mg TID for 10 days and two (2) subjects received placebo TID for 10 days, were studied. Subjects maintained a standard gluten-free diet. Subjects were dosed three times a day 30 minutes prior to meals except for the morning dosing on Days 1, 5, and 10. For the morning dosing on Days 1, 5, and 10 subjects, fasted overnight prior to dosing and for 2 hours post dose. Subjects were evaluated for safety (medical history, physical examination, vital signs, clinical laboratory testing, and 12-lead electrocardiograms) throughout the study. Serial blood samples were collected or pharmacokinetic determinations at baseline and 2 hours post morning dose on Days 1, 2, 5, 6 and 10.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21225
      • Parexel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy male and female subjects
• BMI between 18 and 30.

Exclusion Criteria:

• Subjects with clinically significant abnormal clinical lab results
• Hemoglobin < 12g/dL
• Subjects with diarrhea within 3 days prior to treatment visit

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Larazotide acetate 0.25 mg; larazotide acetate 0.25 mg capsule TID for 10 days	Drug: larazotide acetate; capsule for oral administration; Other Names: AT-1001; INN-202
Experimental: Larazotide acetate 1 mg; larazotide acetate 1 mg capsule TID for 10 days	Drug: larazotide acetate; capsule for oral administration; Other Names: AT-1001; INN-202
Experimental: Larazotide acetate 4 mg; larazotide acetate 4 mg capsule TID for 10 days	Drug: larazotide acetate; capsule for oral administration; Other Names: AT-1001; INN-202
Experimental: Placebo; Placebo capsule TID for 10 days	Drug: larazotide acetate; capsule for oral administration; Other Names: AT-1001; INN-202

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demonstrate the safety and tolerance of multiple, oral doses of larazotide acetate	Safety evaluations included medical history, physical examination, vital signs, clinical laboratory testing, and 12-lead electrocardiograms	Subjects were evaluated for safety at screening, prior to administration of treatment, and following dosing of the study drug.
Determine whether quantifiable concentrations of larazotide acetate are present in plasma following multiple oral doses and characterize the pharmacokinetic behavior of larazotide acetate in healthy 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 multiple oral doses and to characterize the pharmacokinetic behavior of larazotide acetate in celiac disease subjects.	Serial blood samples were collected for pharmacokinetic determinations at baseline and 2 hours post morning dose on Days 1, 2, 5, 6 and 10.

Collaborators and Investigators

• Sponsor: 9 Meters Biopharma, Inc.
• Investigators: Study Chair: Blake Paterson, MD, Alba Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2006
• Primary Completion (Actual): February 27, 2006
• Study Completion (Actual): February 27, 2006

Study Registration Dates

• First Submitted: October 9, 2006
• First Submitted That Met QC Criteria: October 10, 2006
• First Posted (Estimate): October 11, 2006

Study Record Updates

• Last Update Posted (Actual): September 12, 2017
• Last Update Submitted That Met QC Criteria: September 8, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: celiac disease; larazotide acetate
• Other Study ID Numbers: CLIN1001-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No