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Safety of Larazotide Acetate in Healthy Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00386490
First Posted: October 11, 2006
Last Update Posted: September 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Innovate Biopharmaceuticals
October 9, 2006
October 11, 2006
September 12, 2017
January 10, 2006
February 27, 2006   (Final data collection date for primary outcome measure)
  • 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
  • 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.
  • To demonstrate the safety and tolerance of multiple, oral doses of AT-1001
  • To determine whether quantifiable AT-1001 concentrations are present in plasma following oral drug administration and to characterize the pharmacokinetic behavior of AT-1001
Complete list of historical versions of study NCT00386490 on ClinicalTrials.gov Archive Site
Not Provided
Pharmacokinetic Measures
Not Provided
Not Provided
 
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.
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.
Interventional
Phase 1
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
Healthy
Drug: larazotide acetate
capsule for oral administration
Other Names:
  • AT-1001
  • INN-202
  • Experimental: Larazotide acetate 0.25 mg
    larazotide acetate 0.25 mg capsule TID for 10 days
    Intervention: Drug: larazotide acetate
  • Experimental: Larazotide acetate 1 mg
    larazotide acetate 1 mg capsule TID for 10 days
    Intervention: Drug: larazotide acetate
  • Experimental: Larazotide acetate 4 mg
    larazotide acetate 4 mg capsule TID for 10 days
    Intervention: Drug: larazotide acetate
  • Experimental: Placebo
    Placebo capsule TID for 10 days
    Intervention: Drug: larazotide acetate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
February 27, 2006
February 27, 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00386490
CLIN1001-003
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Innovate Biopharmaceuticals
Innovate Biopharmaceuticals
Not Provided
Study Chair: Blake Paterson, MD Alba Therapeutics
Innovate Biopharmaceuticals
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP