Status:
COMPLETED
Safety of Larazotide Acetate in Healthy Volunteers
Lead Sponsor:
9 Meters Biopharma, Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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 larazotid...
Eligibility Criteria
Inclusion
- Healthy male and female subjects
- BMI between 18 and 30.
Exclusion
- Subjects with clinically significant abnormal clinical lab results
- Hemoglobin \< 12g/dL
- Subjects with diarrhea within 3 days prior to treatment visit
Key Trial Info
Start Date :
January 10 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 27 2006
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00386490
Start Date
January 10 2006
End Date
February 27 2006
Last Update
September 12 2017
Active Locations (1)
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1
Parexel
Baltimore, Maryland, United States, 21225