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

NCT00669825 | Completed Phase 1

• 1 other identifier: ALV003-0812
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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.

Conditions

Celiac Disease

Keywords

Celiac Disease

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability

  Throughout

Study Arms (2)

A

PLACEBO COMPARATOR

Placebo

Drug: Placebo

B

ACTIVE COMPARATOR

ALV003 (Active Study Drug)

Drug: ALV003

Interventions

ALV003 DRUG

Doses via intragastric tube at dosages of either 100 mg, 300 mg, 900 mg, or 1800 mg

B

Placebo DRUG

Placebo to be administered via intragastric tube

A

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Alvine Pharmaceuticals Inc.: lead

Study Sites (2)

Clinical Applications Laboratories, Inc.

San Diego, California, 92103, United States

Location

Clinical Applications Laboratories

San Diego, California, 92103, United States

Location

Related Links

• Alvine Pharmaceuticals, Inc.

MeSH Terms

Conditions

Celiac Disease

Interventions

ALV003

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Vijaya Pratha, MD

  Clinical Applications Laboratories

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 21, 2008
• First Posted: May 1, 2008
• Study Start: March 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: February 19, 2010

Record last verified: 2010-02

Locations

US (2)