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Safety of Larazotide Acetate in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT00386490
Recruitment Status : Completed
First Posted : October 11, 2006
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):
Innovate Biopharmaceuticals

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

Condition or disease Intervention/treatment Phase
Healthy Drug: larazotide acetate Phase 1

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  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Phase 1, randomized, double-blind, placebo controlled multi-dose study
Masking: Double (Participant, Investigator)
Masking Description: double-blind
Primary Purpose: Basic Science
Official Title: 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
Actual Study Start Date : January 10, 2006
Actual Primary Completion Date : February 27, 2006
Actual Study Completion Date : February 27, 2006

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



Primary Outcome Measures :
  1. Demonstrate the safety and tolerance of multiple, oral doses of larazotide acetate [ Time Frame: Subjects were evaluated for safety at screening, prior to administration of treatment, and following dosing of the study drug. ]
    Safety evaluations included medical history, physical examination, vital signs, clinical laboratory testing, and 12-lead electrocardiograms

  2. 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 [ Time Frame: Serial blood samples were collected for pharmacokinetic determinations at baseline and 2 hours post morning dose on Days 1, 2, 5, 6 and 10. ]
    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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00386490


Locations
United States, Maryland
Parexel
Baltimore, Maryland, United States, 21225
Sponsors and Collaborators
Innovate Biopharmaceuticals
Investigators
Study Chair: Blake Paterson, MD Alba Therapeutics

Responsible Party: Innovate Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT00386490     History of Changes
Other Study ID Numbers: CLIN1001-003
First Posted: October 11, 2006    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Innovate Biopharmaceuticals:
celiac disease
larazotide acetate