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

January 27, 2012
July 2, 2014
March 2012
November 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01523184 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
A Phase 2 Study to Evaluate Pharmacodynamics of YKP10811 in Patients With Chronic or Functional Constipation
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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Chronic Constipation
  • Functional Constipation
  • Drug: Placebo Capsule
    This is the placebo capsule
  • Drug: YKP10811 Drug Product Capsule
    The drug product, YKP10811, 10 mg under investigation
  • Drug: YKP10811 Drug Product Capsule
    The drug product, YKP10811, 20 mg under investigation
  • Drug: YKP10811 Drug Product Capsule
    The drug product, YKP10811, 30 mg under investigation
  • Placebo Comparator: Placebo Capsule
    Placebo Capsules
    Intervention: Drug: Placebo Capsule
  • Active Comparator: YKP10811 Drug Product Capsule, 10 mg
    Intervention: Drug: YKP10811 Drug Product Capsule
  • Active Comparator: YKP10811 Drug Product Capsule, 20 mg
    Intervention: Drug: YKP10811 Drug Product Capsule
  • Active Comparator: YKP10811 Drug Product Capsule, 30 mg
    Intervention: Drug: YKP10811 Drug Product Capsule
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
57
November 2013
November 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01523184
YKP10811C003
No
SK Life Science
SK Life Science
Not Provided
Principal Investigator: Michael Camilleri, MD Mayo Clinic
SK Life Science
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP