Status:
COMPLETED
Study of ALV003 in Healthy Adult Volunteers and Subjects With Well-Controlled Celiac Disease Following a Gluten-Containing Meal
Lead Sponsor:
Alvine Pharmaceuticals Inc.
Conditions:
Celiac Disease
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
ALV003-0812 is a study of the safety and tolerability of a study drug (ALV003) in healthy adult volunteers and in patients with well-controlled celiac disease, following a meal that contains gluten.
Detailed Description
ALV003-0812 (the FED study) is designed to evaluate the safety and tolerability of a single dose of the study drug, ALV003, administered at one of four different dose levels, and following a test meal...
Eligibility Criteria
Inclusion
- Ages 18 to 45 years (inclusive)
- Healthy volunteers, in good health on the basis of medical history, physical examination, and laboratory values to include: hematology, chemistry, urinalysis, and liver function tests.
- Subjects with well-controlled celiac disease (CD), in good health with the exception of CD
- history of biopsy-proven CD in past 5 years
- on gluten free diet for at least 8 weeks prior to enrollment
- tTG or DGP titers within normal limits (≤ 15 IU)
- no flare in symptoms for the past 8 weeks
- Male or non-lactating, non-pregnant females who are postmenopausal, sterile or using at least two acceptable and highly effective birth control methods
- No systemic biologics may be taken for at least 6 months prior to Visit 2 and through 24 hours post-dose at Visit 3 Other than birth control, no prescribed medications, NSAIDs or aspirin may be taken for at least 7 days prior to Visit 2 and through 24 hours post-dose at Visit 3.
- No probiotics may be taken for at least 5 days prior to Visit 2 and through 24 hours post-dose at Visit 3.
- No over-the-counter medications and supplements may be taken for at least 3 days prior to Visit 2 and through 24 hours post-dose at Visit 3
- Body Mass Index of \< 30 kg/m2
- Have understood and signed an Informed Consent Form
- Able and willing to comply with study requirements
Exclusion
- Positive urine test for alcohol or illegal drugs at screening
- Positive breath test for Helicobacter pylori
- History (within the last 5 years) of inadequate acid secretion, either through a pentagastrin stimulated acid secretion test or fasting intragastric pH 2.5 or greater assessed by passage of a gastric pH probe in the fasting condition
- Aspirin or nonsteroidal anti-inflammatory drugs within 7 days prior to nasogastric or orogastric intubation at Visit 2
- The subject has received an experimental drug within 30 days
- History of substance abuse within the past 5 years
- Clinically significant abnormal lab values, as determined by the PI
- Liver Function Tests \> 2.5 times Upper Limit of Normal (ULN)
- Serum Creatinine \> 1.5 mg/dL
- Hemoglobin (Hb) \< 10 g/dL
- Hematocrit outside of the normal range
- Platelet count \< 150,000
- Serum Potassium, Prothrombin Time (PT), Partial Thromboplastin Time (PTT), or white blood cell count (WBC) outside of the normal range
- History of tobacco use within the last 6 months
- History of untreated or active peptic ulcer disease, esophagitis, motility disorders or any GI diseases in the past year
- Chronic use (more than once a week) of antacids, H2 receptor blockers or proton pump inhibitors
- Alcohol consumption of \> 2 standard drinks equivalents per day
- Positive pregnancy test within 7 days prior to study drug administration
- Medical history (Healthy volunteers)
- gluten intolerance
- first degree relative diagnosed with celiac disease
- history of food allergies or digestive enzyme deficiencies
- history of any medically significant condition considered by PI to adversely affect participation
- chronic disease or condition
- Medical History (well-controlled CD subjects)
- history of any medically significant condition (other than CD) considered by PI to adversely affect participation
- chronic disease or condition other than CD
- history of severe reactions to low doses of gluten/accidental exposure to gluten
- History of a condition that is contraindicated for nasogastric or orogastric intubation
- Known allergy or hypersensitivity to any of the components of the test meal, placebo, study drug, E. coli-derived proteins or the 25% dextrose and water solution that will be used to flush the tube immediately following dosing
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2008
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00669825
Start Date
March 1 2008
End Date
October 1 2008
Last Update
February 19 2010
Active Locations (2)
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1
Clinical Applications Laboratories, Inc.
San Diego, California, United States, 92103
2
Clinical Applications Laboratories
San Diego, California, United States, 92103