Safety of Larazotide Acetate in Healthy Volunteers

NCT00386490 | Completed Phase 1 FDA Drug

• 1 other identifier: CLIN1001-003
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

celiac disease; larazotide acetate

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (4)

Larazotide acetate 0.25 mg

EXPERIMENTAL

larazotide acetate 0.25 mg capsule TID for 10 days

Drug: larazotide acetate

Larazotide acetate 1 mg

EXPERIMENTAL

larazotide acetate 1 mg capsule TID for 10 days

Drug: larazotide acetate

Larazotide acetate 4 mg

EXPERIMENTAL

larazotide acetate 4 mg capsule TID for 10 days

Drug: larazotide acetate

Placebo

EXPERIMENTAL

Placebo capsule TID for 10 days

Drug: larazotide acetate

Interventions

larazotide acetate DRUG

capsule for oral administration

Also known as: AT-1001, INN-202

Larazotide acetate 0.25 mg; Larazotide acetate 1 mg; Larazotide acetate 4 mg; Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and female subjects
• BMI between 18 and 30.

You may not qualify if:

• Subjects with clinically significant abnormal clinical lab results
• Hemoglobin \< 12g/dL
• Subjects with diarrhea within 3 days prior to treatment visit

Sponsors & Collaborators

• 9 Meters Biopharma, Inc.: lead

Study Sites (1)

Parexel

Baltimore, Maryland, 21225, United States

Location

MeSH Terms

Conditions

Celiac Disease

Interventions

larazotide acetate

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Blake Paterson, MD

  Alba Therapeutics

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-blind
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 1, randomized, double-blind, placebo controlled multi-dose study

Study Record Dates

• First Submitted: October 9, 2006
• First Posted: October 11, 2006
• Study Start: January 10, 2006
• Primary Completion: February 27, 2006
• Study Completion: February 27, 2006
• Last Updated: September 12, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)