Phase 2 Study of MD-1100 Acetate Administered for 14 Days to Patients Meeting Criteria for Chronic Constipation

Inclusion Criteria

• •Male or non-pregnant, non-breastfeeding female, age 18-70 years old at the time of first dose;
• •Sexually active patients of childbearing potential agree to use double-barrier birth control;
• •Females of childbearing potential must complete negative pregnancy tests prior to first dose;
• •Negative colonoscopy within 10 years or completion of negative flexible sigmoidoscopy if under the age of 50 provided there is no history of rectal bleeding, weight loss, or anemia;
• •BMI must be greater than/equal to 18.5 and less than 35.0;
• •Successful completion of physical exam, 12-lead ECG, clinical laboratory tests prior to first dose of study medication;
• •Vital signs must not have clinically-significant findings within 4 hours of first dose of study medication;
• •Patient reports 3 or less spontaneous bowel movements (SBMs) per week and meets 1 or more of the following criteria for constipation for 12 weeks in the previous 12 months: straining at least 25% bowel movements (BMs), lumpy or hard stools at least 25% of BMs, or sensation of incomplete evacuation at least 25% of BMs;
• •Patient reports 3 or less SBMs during the 7-day Pre-treatment Period;
• •Patient is compliant with IVRS for at least 6 days in the 7-day Pre-treatment Period.