Celiac DiseasePhase 1FEDNCT00669825
Study of ALV003 in Healthy Adult Volunteers and Subjects With Well-Controlled Celiac Disease Following a Gluten-Containing Meal
A Phase 1 study testing ALV003 in people with Celiac Disease, run by Alvine Pharmaceuticals Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Celiac Disease
- What is being tested?
- ALV003
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2008to Oct 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Clinical Applications Laboratories, Inc.
San Diego, California, 92103
Clinical Applications Laboratories
San Diego, California, 92103
About this study
Official title: 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.
Read the 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.
- Conditions
- Celiac Disease
- Being tested
- ALV003, Placebo
- Keywords
- Celiac Disease
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALV003Drug
Doses via intragastric tube at dosages of either 100 mg, 300 mg, 900 mg, or 1800 mg
PlaceboDrug
Placebo to be administered via intragastric tube
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | Placebo Receives: Drug: Placebo |
| B | Active comparator | ALV003 (Active Study Drug) Receives: Drug: ALV003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
Measured: Throughout
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2008 (estimated)
- Study startMar 2008
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alvine Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Vijaya Pratha, MD, Principal investigator, Clinical Applications Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00669825
- Sponsor's protocol ID
- ALV003-0812
- Acronym
- FED
- Status last verified
- Feb 2010
- First submitted
- 21 Apr 2008
- Last updated
- 19 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00669825
- Acronym / sponsor ID
- FED / ALV003-0812
- Conditions
- Celiac Disease
- Keywords
- Celiac Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Alvine Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 1 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Drug: PlaceboPlacebo |
| B | Active comparator | Drug: ALV003ALV003 (Active Study Drug) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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
- 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.
Key exclusion criteria (30 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALV003Doses via intragastric tube at dosages of either 100 mg, 300 mg, 900 mg, or 1800 mg | Drug | B |
| PlaceboPlacebo to be administered via intragastric tube | Drug | A |
Primary outcome
Safety and Tolerability
Time frame: Throughout
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2010.
Related trials for Celiac Disease
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vijaya Pratha, MD principal investigator
Clinical Applications Laboratories
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ALV003 in people with Celiac Disease, run by Alvine Pharmaceuticals Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability (time frame: Throughout). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2010.