A Phase 2 Study to Evaluate Pharmacodynamics of YKP10811 in Patients With Chronic or Functional Constipation
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Constipation Functional Constipation |
Drug: Placebo Capsule Drug: YKP10811 Drug Product Capsule |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
- Colonic Geometric Center (GC) at 24 hours [ Time Frame: 48 hours ] [ Designated as safety issue: No ]The colonic GC at 24 hours is the measurement of the move of the food within the GI track.
- Gastric emptying half time [ Time Frame: 4 hours ] [ Designated as safety issue: No ]The gastric emptying half time is the time to empty the half of the ingested solid food in the stomach.
| Estimated Enrollment: | 100 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo Capsule
Placebo Capsules
|
Drug: Placebo Capsule
This is the placebo capsule
|
| Active Comparator: YKP10811 Drug Product Capsule, 10 mg |
Drug: YKP10811 Drug Product Capsule
The drug product, YKP10811, 10 mg under investigation
|
| Active Comparator: YKP10811 Drug Product Capsule, 20 mg |
Drug: YKP10811 Drug Product Capsule
The drug product, YKP10811, 20 mg under investigation
|
| Active Comparator: YKP10811 Drug Product Capsule, 30 mg |
Drug: YKP10811 Drug Product Capsule
The drug product, YKP10811, 30 mg under investigation
|
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| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
- Body Mass Index of 19 through 40 kg/m2
- Participants must be willing to follow dietary restrictions
- Females of childbearing potential (ie, not menopausal, no hysterectomy, no bilateral oophorectomy) must complete a negative pregnancy test (urine) prior to receiving any radioisotopes
- No evidence of pelvic floor dysfunction
- If clinically indicated, absence of an evacuation disorder should be confirmed within 30 days prior to the first dose of study medication
- At Screening, patients must meet ROME III Criteria for FC, which assumes an absence of a structural or biochemical explanation
- The patient's screening (baseline) colonic transit test must show a GC ≤ 2.4 at 24 hours; and
- Baseline EKG shows QTc interval ≤ 450mSec
Exclusion Criteria:
- History of clinically-significant manifestations or current abnormality of any organ system
- History of inflammatory bowel disease
- Any history of GI surgery within 6 months prior to the first dose of study medication
- History of clinically-significant prolonged diarrhea, in the absence of a laxative
- 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
- Any clinically-significant surgical procedure within 30 days prior to the first dose of study medication
- History of alcoholism or drug addiction within 12 months prior to the first dose of study medication
- 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
- Patients who are breastfeeding
Contacts and Locations| Contact: Marc Kamin, MD | 201 421 3830 | mkamin@sklsi.com |
| Contact: Hong Wook Kim, Ph.D. | 201 421 3803 | hwkim@sklsi.com |
| United States, Minnesota | |
| Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Amy Boldingh 507-538-6599 Boldingh.Amy@mayo.edu | |
| Principal Investigator: Michael Camilleri, MD | |
| Principal Investigator: | Michael Camilleri, MD | Mayo Clinic |
More Information
No publications provided
| Responsible Party: | SK Life Science |
| ClinicalTrials.gov Identifier: | NCT01523184 History of Changes |
| Other Study ID Numbers: | YKP10811C003 |
| Study First Received: | January 27, 2012 |
| Last Updated: | January 15, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by SK Life Science:
|
Chronic constipation (CC) Functional Constipation (FC) Gastric Emptying Colon Transit |
multiple doses of YKP10811 gastrointestinal transit colonic transit |
Additional relevant MeSH terms:
|
Constipation Signs and Symptoms, Digestive Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013