Clinical trial NCT01523184: A Phase 2 Study to Evaluate Pharmacodynamics of YKP10811 in Patients With Chronic or Functional Constipation
Official title: A Phase II, Single-Center, Randomized, Parallel Group, Multiple Administration, Double-Blind, Placebo-Controlled Study to Evaluate the Pharmacodynamics of YKP10811 in Patients With Chronic or Functional Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Constipation
Functional Constipation
Keywords: Chronic constipation (CC)
Functional Constipation (FC)
Gastric Emptying
Colon Transit
multiple doses of YKP10811
gastrointestinal transit
colonic transit
Lead sponsor: SK Life Science, Inc.
Sponsor class: INDUSTRY
First posted: 2012-02-01
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Non-smokers (refrained from any tobacco or nicotine usage, including smokeless tobacco, nicotine patches, etc.) for at least 6 months prior to Day 1 of the study
2. Body Mass Index of 19 through 40 kg/m2
3. Participants must be willing to follow dietary restrictions
4. Females of childbearing potential (ie, not menopausal, no hysterectomy, no bilateral oophorectomy) must complete a negative pregnancy test (urine) prior to receiving any radioisotopes
5. No evidence of pelvic floor dysfunction
6. If clinically indicated, absence of an evacuation disorder should be confirmed within 30 days prior to the first dose of study medication
7. At Screening, patients must meet ROME III Criteria for FC, which assumes an absence of a structural or biochemical explanation
8. The patient's screening (baseline) colonic transit test must show a GC ≤ 2.4 at 24 hours; and
9. Baseline EKG shows QTc interval ≤ 450mSec

Exclusion Criteria:

1. History of clinically-significant manifestations or current abnormality of any organ system
2. History of inflammatory bowel disease
3. Any history of GI surgery within 6 months prior to the first dose of study medication
4. History of clinically-significant prolonged diarrhea, in the absence of a laxative
5. Patients who have started a special dietary habit and/or an intense physical workout program within 4 weeks prior to the first dose of study medication
6. Any clinically-significant surgical procedure within 30 days prior to the first dose of study medication
7. History of alcoholism or drug addiction within 12 months prior to the first dose of study medication
8. Any patient who has had an acute illness within 5 days prior to the first dose of study medication, eg, flu syndrome, GI virus, indigestion
9. Patients who are breastfeeding

Primary outcomes:
measure: Colonic Geometric Center (GC) at 24 hours
timeFrame: 48 hours
Secondary outcomes:
measure: Gastric emptying half time
timeFrame: 4 hours
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Michael Camilleri, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.