A Pilot Efficacy Evaluation of BLI-801 as a Laxative in Constipated Adults

Inclusion Criteria: * Male or female subjects at least 18 years of age * Constipated according to ROME I criteria * Otherwise in good health, as determined by physical exam and medical history * If female, and of child-bearing potential, is using an acceptable form of birth control (hormonal birth control, IUD, double-barrier method, depot contraceptive, sterilized, abstinent, or vasectomized spouse) * Negative urine pregnancy test at screening, if applicable * In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study Exclusion Criteria: * Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon * Subjects taking laxatives or prokinetic agents that refuse to discontinue these treatments for the duration of the study * Subjects who are pregnant or lactating, or intending to become pregnant during the study * Subjects of childbearing potential who refuse a pregnancy test * Subjects who are allergic to any BLI-801 component. * Subjects who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedures * Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days