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

NCT ID: NCT01523184

Last Updated: 2014-07-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2013-11-30

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.

Conditions

Chronic Constipation; Functional Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo Capsule

Placebo Capsules

Group Type: PLACEBO_COMPARATOR

Placebo Capsule

Intervention Type: DRUG

This is the placebo capsule

YKP10811 Drug Product Capsule, 10 mg

Group Type: ACTIVE_COMPARATOR

YKP10811 Drug Product Capsule

Intervention Type: DRUG

The drug product, YKP10811, 10 mg under investigation

YKP10811 Drug Product Capsule, 20 mg

Group Type: ACTIVE_COMPARATOR

YKP10811 Drug Product Capsule

Intervention Type: DRUG

The drug product, YKP10811, 20 mg under investigation

YKP10811 Drug Product Capsule, 30 mg

Group Type: ACTIVE_COMPARATOR

YKP10811 Drug Product Capsule

Intervention Type: DRUG

The drug product, YKP10811, 30 mg under investigation

Interventions

Placebo Capsule

This is the placebo capsule

Intervention Type: DRUG

YKP10811 Drug Product Capsule

The drug product, YKP10811, 10 mg under investigation

Intervention Type: DRUG

YKP10811 Drug Product Capsule

The drug product, YKP10811, 20 mg under investigation

Intervention Type: DRUG

YKP10811 Drug Product Capsule

The drug product, YKP10811, 30 mg under investigation

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SK Life Science, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Camilleri, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 25148765 (View on PubMed)

Other Identifiers

YKP10811C003

Identifier Type: -

Identifier Source: org_study_id