Healthy
Conditions
Keywords
celiac disease, larazotide acetate
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.
Interventions
capsule for oral administration
Sponsors
9 Meters Biopharma, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Masking description
double-blind
Intervention model description
Phase 1, randomized, double-blind, placebo controlled multi-dose study
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed