Safety of Larazotide Acetate in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: larazotide acetate

• Registration Number: NCT00386490
• Lead Sponsor: 9 Meters Biopharma, Inc.

Brief Summary

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

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 Timeline

• Study Start: 2006-01-10
• Primary Completion: 2006-02-27
• Study Completion: 2006-02-27
• Study First Submitted: 2006-10-09
• Study First Submitted QC: 2006-10-10
• Study First Posted: 2006-10-11
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-08
• Last Update Posted: 2017-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Larazotide acetate 1 mg	larazotide acetate	larazotide acetate 1 mg capsule TID for 10 days
Larazotide acetate 0.25 mg	larazotide acetate	larazotide acetate 0.25 mg capsule TID for 10 days
Larazotide acetate 4 mg	larazotide acetate	larazotide acetate 4 mg capsule TID for 10 days
Placebo	larazotide acetate	Placebo capsule TID for 10 days

Primary Outcome Measures

Name	Time	Method
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
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.

Trial Locations

Locations (1)

Parexel; 🇺🇸 Baltimore, Maryland, United States