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

Functional Constipation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01523184
• Other study ID #: YKP10811C003
• Status: Completed
• Phase: Phase 2
• First received: January 27, 2012
• Last updated: July 2, 2014
• Start date: March 2012
• Est. completion date: November 2013

Study information

• Verified date: July 2014
• Source: SK Life Science
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Constipation
• Constipation
• Functional Constipation

Intervention

Drug:
• Placebo Capsule
This is the placebo capsule
• YKP10811 Drug Product Capsule
The drug product, YKP10811, 10 mg under investigation
• YKP10811 Drug Product Capsule
The drug product, YKP10811, 20 mg under investigation
• YKP10811 Drug Product Capsule
The drug product, YKP10811, 30 mg under investigation

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
SK Life Science

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No