- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00669825
Study of ALV003 in Healthy Adult Volunteers and Subjects With Well-Controlled Celiac Disease Following a Gluten-Containing Meal (FED)
February 17, 2010 updated by: Alvine Pharmaceuticals Inc.
A Phase 1, Two Stage, Single-Blind, Single Dose, Placebo Controlled, Dose Escalation, Crossover Study of the Safety and Tolerability of ALV003 in Healthy Adult Volunteers and Subjects With Well-Controlled Celiac Disease Following a Gluten-Containing Meal
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.
Study Overview
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 containing a small amount (1 gram) of gluten.
ALV003 has been demonstrated to proteolyze (assist with the digestion of) various forms of gluten (gluten flour, wheat bread) in laboratory studies and in animals.
Celiac disease has been estimated to affect 1% of the population of the United States, is related to gluten, and has a wide range of clinical manifestations including chronic gastrointestinal symptoms, malabsorption, and bone disease.
Study Type
Interventional
Enrollment (Anticipated)
36
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
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San Diego, California, United States, 92103
- Clinical Applications Laboratories, Inc.
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San Diego, California, United States, 92103
- Clinical Applications Laboratories
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NON_RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: A
Placebo
|
Placebo to be administered via intragastric tube
|
ACTIVE_COMPARATOR: B
ALV003 (Active Study Drug)
|
Doses via intragastric tube at dosages of either 100 mg, 300 mg, 900 mg, or 1800 mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety and Tolerability
Time Frame: Throughout
|
Throughout
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Vijaya Pratha, MD, Clinical Applications Laboratories
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Primary Completion (ACTUAL)
October 1, 2008
Study Completion (ACTUAL)
October 1, 2008
Study Registration Dates
First Submitted
April 21, 2008
First Submitted That Met QC Criteria
April 30, 2008
First Posted (ESTIMATE)
May 1, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
February 19, 2010
Last Update Submitted That Met QC Criteria
February 17, 2010
Last Verified
February 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ALV003-0812
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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