Safety of Larazotide Acetate in Healthy Volunteers

Study Overview
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Brief Summary
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To demonstrate the safety, tolerance and pharmacokinetics of multiple, oral doses of larazotide acetate.

Detailed Description
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: larazotide acetate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Phase 1, randomized, double-blind, placebo controlled multi-dose study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Larazotide acetate 0.25 mg<br>larazotide acetate 0.25 mg capsule TID for 10 days | Drug: larazotide acetate<br>* capsule for oral administration<br>* Other names: INN-202;|
| Experimental: Larazotide acetate 1 mg<br>larazotide acetate 1 mg capsule TID for 10 days | Drug: larazotide acetate<br>* capsule for oral administration<br>* Other names: INN-202;|
| Experimental: Larazotide acetate 4 mg<br>larazotide acetate 4 mg capsule TID for 10 days | Drug: larazotide acetate<br>* capsule for oral administration<br>* Other names: INN-202;|
| Experimental: Placebo<br>Placebo capsule TID for 10 days | Drug: larazotide acetate<br>* capsule for oral administration<br>* Other names: INN-202;|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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celiac disease, larazotide acetate