"Phase 2 Reduction of Dietary Mycotoxin Exposure by ACCS100"

PHASE2CompletedINTERVENTIONAL
Enrollment

234

Participants

Timeline

Start Date

September 30, 2012

Primary Completion Date

August 31, 2014

Study Completion Date

August 31, 2014

Conditions
Dietary Carcinogenesis
Interventions
DRUG

ACCS100

ACCS100 is not absorbed. The dose is estimated based on the volume of the gastrointestinal tract. We estimate that the average human intestinal tract has a volume of approximately 4 liters. In the high dose group, the effective concentration in the gut is 0.75 milligrams per milliliter. In the low dose, the effective concentration in the gut is 0.375 milligrams per milliliter. The test article is made by filling gelatin capsules with 500 milligrams of ACCS100. There are no excipients used in the manufacturing process of the test article.

DRUG

Placebo

Placebo is calcium carbonate, USP. This calcium mineral does not absorb mycotoxins, specifically aflatoxin and fumonisin. This mineral has approximately the same physical appearance as active test article.

Trial Locations (1)

78229

University of Texas Health Science Center Cancer Therapy and Research Center, San Antonio

All Listed Sponsors
collaborator

Texas A&M University

OTHER

collaborator

University of Georgia

OTHER

collaborator

The University of Texas at San Antonio

OTHER

lead

Texas Enterosorbents Incorporated

INDUSTRY

NCT01677195 - "Phase 2 Reduction of Dietary Mycotoxin Exposure by ACCS100" | Biotech Hunter | Biotech Hunter