Study of ALV003 in Healthy Adult Volunteers and Subjects With Well-Controlled Celiac Disease Following a Gluten-Containing Meal

Completed · Phase 1 · Has a placebo group

Conditions studied: Celiac Disease

In brief

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.

Key facts

Study ID

NCT00669825

Run by

Alvine Pharmaceuticals Inc.

People needed

36

Starts

2008-03-01

Expected to finish

2008-10-01

Last updated by the study team

2010-02-19

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Clinical Applications Laboratories, Inc. — San Diego, California, United States
• Clinical Applications Laboratories — San Diego, California, United States

Full record on ClinicalTrials.gov

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