A Phase 2 Study to Evaluate Pharmacodynamics of YKP10811 in Patients With Chronic or Functional Constipation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
SK Life Science
ClinicalTrials.gov Identifier:
NCT01523184
First received: January 27, 2012
Last updated: July 2, 2014
Last verified: July 2014
  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

Resource links provided by NLM:


Further study details as provided by SK Life Science:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 57
Study Start Date: March 2012
Study Completion Date: November 2013
Primary Completion Date: November 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01523184

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
SK Life Science
Investigators
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: July 2, 2014
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
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on October 23, 2014