A Phase 1, Study of the Safety and Tolerability of ALV003 in Healthy Adult Volunteers and Subjects With Well-Controlled Celiac Disease

This study has been completed.

First Received: February 13, 2008 Last Updated: August 17, 2009 History of Changes

Sponsor:	Alvine Pharmaceuticals Inc.
Information provided by:	Alvine Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:	NCT00626184

Purpose

To assess safety and tolerability of ALV003 in healthy volunteers and patients with Celiac Disease

Condition	Intervention	Phase
Celiac Disease	Drug: 4 dose levels of ALV003	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Control: Placebo Control Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	A Phase 1, Two Stage, Single Dose, Single-Blind, Placebo Controlled, Dose Escalation, Crossover Study of the Safety and Tolerability of ALV003 in Healthy Adult Volunteers and Subjects With Well-Controlled Celiac Disease

Resource links provided by NLM:

MedlinePlus related topics: Celiac Disease

U.S. FDA Resources

Further study details as provided by Alvine Pharmaceuticals Inc.:

Primary Outcome Measures:

safety and tolerability [ Time Frame: Throughout ] [ Designated as safety issue: Yes ]

Enrollment:	28
Study Start Date:	February 2008
Study Completion Date:	July 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Placebo Comparator Placebo	Drug: 4 dose levels of ALV003 4 dose levels of ALV003 vs placebo
B: Active Comparator Active study Drug: ALV003	Drug: 4 dose levels of ALV003 4 dose levels of ALV003 vs placebo

Detailed Description:

A Phase 1, Two Stage, Single Dose, Single-Blind, Placebo Controlled, Dose Escalation, Crossover Study of the Safety and Tolerability of ALV003 in Healthy Adult Volunteers and Subjects With Well-Controlled Celiac Disease

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

INCLUSION

Health Status
1. Healthy volunteers must be in good health
2. Celiac Disease must be well controlled and in good health
Either male or non-lactating, non-pregnant females who are postmenopausal, sterile or using at least two acceptable and highly effective birth control methods.
Body Mass Index (BMI) of < 30 kg/m2,

EXCLUSION

A positive urine test for alcohol or illegal drugs at screening.
The subject has received an experimental drug within 30 days of the present study.
History of substance abuse, within the last 5 years
Clinically significant abnormal lab values, as determined by the PI
Alcohol consumption of > 2 standard drinks equivalents per day12. Positive pregnancy test within 7 days prior to study drug administration.
history of any medically significant condition considered by the PI to adversely affect participation in the trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00626184

Locations

United States, California
Clinical Applications Laboratories Inc.
San Diego, California, United States, 92103

Sponsors and Collaborators

Alvine Pharmaceuticals Inc.

Investigators

Principal Investigator:

Vijaya Pratha, MD

Clinical Applications Laboratory Inc.

More Information

Additional Information:

Alvine Home page This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Clinical Applications Laboratories Inc. ( Vijaya Pratha, M.D., Principal Investigator )
ClinicalTrials.gov Identifier:	NCT00626184 History of Changes
Other Study ID Numbers:	ALV003-0811
Study First Received:	February 13, 2008
Last Updated:	August 17, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Alvine Pharmaceuticals Inc.:

Celiac Disease

Additional relevant MeSH terms:

Celiac Disease
Malabsorption Syndromes
Intestinal Diseases

Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on August 31, 2010