Study of ALV003 in Healthy Adult Volunteers and Subjects With Well-Controlled Celiac Disease Following a Gluten-Containing Meal (FED)
Tracking Information | |||||
---|---|---|---|---|---|
First Received Date ICMJE | April 21, 2008 | ||||
Last Updated Date | February 17, 2010 | ||||
Start Date ICMJE | March 2008 | ||||
Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Safety and Tolerability [ Time Frame: Throughout ] [ Designated as safety issue: Yes ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00669825 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Study of ALV003 in Healthy Adult Volunteers and Subjects With Well-Controlled Celiac Disease Following a Gluten-Containing Meal | ||||
Official Title ICMJE | 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 | ||||
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 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 ICMJE | Interventional | ||||
Study Phase | Phase 1 | ||||
Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Basic Science |
||||
Condition ICMJE | Celiac Disease | ||||
Intervention ICMJE |
|
||||
Study Arm (s) |
|
||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Estimated Enrollment ICMJE | 36 | ||||
Completion Date | October 2008 | ||||
Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
Gender | Both | ||||
Ages | 18 Years to 45 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00669825 | ||||
Other Study ID Numbers ICMJE | ALV003-0812 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Vijaya Pratha, MD, Principal Investigator, Clinical Applications Laboratories Inc. | ||||
Study Sponsor ICMJE | Alvine Pharmaceuticals Inc. | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
|
||||
Information Provided By | Alvine Pharmaceuticals Inc. | ||||
Verification Date | February 2010 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |