Safety of Larazotide Acetate in Healthy Volunteers

9 Meters Biopharma

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: larazotide acetate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00386490

CLIN1001-003

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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24 participants in 4 patient groups

Larazotide acetate 0.25 mg

Experimental group

Description:

larazotide acetate 0.25 mg capsule TID for 10 days

Treatment:

Drug: larazotide acetate

Larazotide acetate 1 mg

Experimental group

Description:

larazotide acetate 1 mg capsule TID for 10 days

Treatment:

Drug: larazotide acetate

Larazotide acetate 4 mg

Experimental group

Description:

larazotide acetate 4 mg capsule TID for 10 days

Treatment:

Drug: larazotide acetate

Placebo

Experimental group

Description:

Placebo capsule TID for 10 days

Treatment:

Drug: larazotide acetate