This will be a single-center, randomized, parallel group, multiple dose administration, double-blind, placebo-controlled study to evaluate the effects of YKP10811 on gastric, small bowel, and colonic transit in patients with Chronic Constipation or Functional Constipation. Four groups including a placebo group will be enrolled and will receive multiple oral doses of YKP10811 or matching placebo.
If the participant fulfills the initial eligibility criteria, the patient will be randomized to 1 of the active treatment groups or placebo. During the treatment period, patients will receive study medication once daily for 8 days. Patients will undergo scintigraphic assessment of gastric, small bowel and colonic transit of solids over the 48-hour period. Patients will be males or females, 18 through 65 years of age with a body mass index (BMI) of 19 through 40 kg/m2, with Chronic Constipation or Functional Constipation and no evidence of evacuation disorder as assessed by the Investigator and meet all the inclusion criteria and none of the exclusion criteria.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
57
This is the placebo capsule
The drug product, YKP10811, 10 mg under investigation
The drug product, YKP10811, 20 mg under investigation
Mayo Clinic
Rochester, Minnesota, United States
Colonic Geometric Center (GC) at 24 hours
The colonic GC at 24 hours is the measurement of the move of the food within the GI track.
Time frame: 48 hours
Gastric emptying half time
The gastric emptying half time is the time to empty the half of the ingested solid food in the stomach.
Time frame: 4 hours
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The drug product, YKP10811, 30 mg under investigation