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Safety of Larazotide Acetate in Healthy Volunteers

Sponsor
9 Meters Biopharma, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00386490
Collaborator
(none)
24
Enrollment
1
Location
4
Arms
1.6
Actual Duration (Months)
15.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
Phase 1, randomized, double-blind, placebo controlled multi-dose studyPhase 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 :
Jan 10, 2006
Actual Primary Completion Date :
Feb 27, 2006
Actual Study Completion Date :
Feb 27, 2006

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Demonstrate the safety and tolerance of multiple, oral doses of larazotide acetate [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Parexel Baltimore Maryland United States 21225

    Sponsors and Collaborators

    • 9 Meters Biopharma, Inc.

    Investigators

    • Study Chair: Blake Paterson, MD, Alba Therapeutics

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    9 Meters Biopharma, Inc.
    ClinicalTrials.gov Identifier:
    NCT00386490
    Other Study ID Numbers:
    • CLIN1001-003
    First Posted:
    Oct 11, 2006
    Last Update Posted:
    Sep 12, 2017
    Last Verified:
    Sep 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    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 9 Meters Biopharma, Inc.
    celiac disease
    larazotide acetate

    Study Results

    No Results Posted as of Sep 12, 2017