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Trial · Interventional

CompletedPhase 1Registry data

Safety of Larazotide Acetate in Healthy Volunteers

NCTNCT00386490 (opens ClinicalTrials.gov in a new tab)Other idCLIN1001-003
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
24 participants (actual)
Sponsor
9 Meters Biopharma, Inc. · Industry
Design
Randomized · Double masking
Countries
1 country

United States

Start
10 Jan 2006
Primary completion
27 Feb 2006
Completion
27 Feb 2006
First posted
11 Oct 2006 (estimated)
Last update posted
12 Sept 2017
Conditions
Healthy

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20062007
  1. Ph 1

    Safety of Larazotide Acetate in Healthy Volunteers

    NCT00386490

    10 Jan 2006 to 27 Feb 2006

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • larazotide acetateDrug

Arms4

  • Experimental

    Larazotide acetate 0.25 mg

    larazotide acetate 0.25 mg capsule TID for 10 days

  • Experimental

    Larazotide acetate 1 mg

    larazotide acetate 1 mg capsule TID for 10 days

  • Experimental

    Larazotide acetate 4 mg

    larazotide acetate 4 mg capsule TID for 10 days

  • Experimental

    Placebo

    Placebo capsule TID for 10 days

Primary outcomes2

Outcomes the sponsor listed as primary.

  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.

    Registry description

    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.

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 45 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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