Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Capsule | Placebo Comparator | Placebo Capsules |
|
| YKP10811 Drug Product Capsule, 10 mg | Active Comparator |
| |
| YKP10811 Drug Product Capsule, 20 mg | Active Comparator |
| |
| YKP10811 Drug Product Capsule, 30 mg | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo Capsule | Drug | This is the placebo capsule |
| |
| YKP10811 Drug Product Capsule |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Gastric emptying half time | The gastric emptying half time is the time to empty the half of the ingested solid food in the stomach. | 4 hours |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael Camilleri, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25148765 | Derived | Shin A, Acosta A, Camilleri M, Boldingh A, Burton D, Ryks M, Rhoten D, Zinsmeister AR. A randomized trial of 5-hydroxytryptamine4-receptor agonist, YKP10811, on colonic transit and bowel function in functional constipation. Clin Gastroenterol Hepatol. 2015 Apr;13(4):701-8.e1. doi: 10.1016/j.cgh.2014.08.012. Epub 2014 Aug 19. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
The drug product, YKP10811, 10 mg under investigation |
|
| YKP10811 Drug Product Capsule | Drug | The drug product, YKP10811, 20 mg under investigation |
|
| YKP10811 Drug Product Capsule | Drug | The drug product, YKP10811, 30 mg under investigation |
|