Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00386490
Status:
COMPLETED
Last Update Posted:
2017-09-12
First Post:
2006-10-09
Brief Title:
Safety of Larazotide Acetate in Healthy Volunteers
Sponsor:
9 Meters Biopharma Inc
Organization:
9 Meters Biopharma Inc
Study Overview
Official Title:
A Phase 1 Randomized Double-Blind Placebo Controlled Multi-Dose Study to Determine the Safety Tolerance and Pharmacokinetics of 3 Dose Levels of Larazotide Acetate AT-1001 in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 025 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None