NCT00263237

STA-5326 Meslylate to Treat Gut Inflammation Associated With Common Variable Immunodeficiency

Completed Phase 1 Last updated 2 July 2017

What this trial tests

Phase 1 trial testing STA-5326 in Common Variable Immunodeficiency in 10 participants. Completed in 23 July 2008.

Timeline

2 December 2005

23 July 2008

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Primary purpose	treatment
Enrollment	10
Start date	2 December 2005
Estimated completion	23 July 2008
Sites	1 location across United States

Drugs / interventions tested

• STA-5326

Conditions studied

• Common Variable Immunodeficiency — all drugs for Common Variable Immunodeficiency →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 75, any sex, with Common Variable Immunodeficiency. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will determine whether an experimental medicine, STA-5326 mesylate, is safe to use in patients with common variable immunodeficiency (CVID) who have inflammation of the gut. It will also determine if patients who take this drug show improvement in their symptoms, decrease in inflammatory chemicals in the gut, changes in their immune cells, and improvement in how their gut is functioning to absorb food.

Patients between 18 and 75 years of age with CVID and chronic diarrhea or involuntary weight loss of more than 5 percent of their past body weight over the past 12 months may be eligible for this study. Candidates are screened with a review of their medical records, a medical history and physical examination, blood, urine and stool tests, chest x-rays and skin test for exposure to tuberculosis, and a hydrogen breath test. For the latter, breath samples are collected before and every 20 minutes (for 2 hours) after the subject drinks a sugar solution. This test determines the digestive effects of bacteria in the upper intestine. Samples are collected by having the subject blow into a balloon.

Participants undergo the following tests and procedures:

Immune System and Gastrointestinal Evaluation

* 48-hour stool fat collection (measures the amount of undigested fat in the stool): Subjects keep a diary of what they eat for a 48-hour period. At the beginning of the 48 hours they take two dye capsules and then take another two capsules 48 hours later. They collect a stool sample when they pass the second set of capsules in their bowel movement. An additional 24-hour stool collection is tested for loss of protein in the stool.
* D-xylose absorption test (measures the ability of the gut to absorb nutrients): Subjects drink a solution of d-xylose (a sugar substitute). Blood samples are collected before and 1 hour after drinking the solution.
* Upper endoscopy: A thin flexible lighted tube is advanced through the mouth to evaluate the esophagus, stomach and beginning of the small intestine.
* Lower endoscopy: A thin flexible lighted tube is advanced through the rectum to evaluate the colon.

Treatment Period (Study days 1 to 57)

* Physical examination - study days 1, 8, 15, 29, 43 and 57
* Blood samples to test the levels of STA-5326 in the blood. On study days 1 and 57, samples are collected before the medication dose and 1, 2, 4, 6 and 8 hours after the dose; on day 29, one sample is collected before the medication dose.
* Blood samples for routine safety testing - study days 1, 8, 15, 29, 43 and 57
* Medication history - study days 1, 8, 15, 29, 43 and 57
* Interview about pain, discomfort, and well being - study days 1, 8, 15, 29, 43 and 57
* Pregnancy test for women who can become pregnant - study days 15, 43, and 57
* D-xylose absorption test - study days 29 and 57
* Electrocardiogram - study days 29 and 57
* Urine test - study days 29 and 57
* Blood test for research on immune cells - study day 57
* Repeat endoscopies and studies of gut function (24- and 48-hour stool collections)

Follow-up period (Day 85 and day 113)

-Physical examination, blood tests, medication history, questions about pain, discomfort and well being

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.