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

Primary Purpose

Chronic Constipation, Functional Constipation

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Placebo Capsule

YKP10811 Drug Product Capsule

About this trial

This is an interventional treatment trial for Chronic Constipation focused on measuring Chronic constipation (CC), Functional Constipation (FC), Gastric Emptying, Colon Transit, multiple doses of YKP10811, gastrointestinal transit, colonic transit

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo Capsule

YKP10811 Drug Product Capsule, 10 mg

YKP10811 Drug Product Capsule, 20 mg

YKP10811 Drug Product Capsule, 30 mg

Arm Description

Placebo Capsules

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Gastric emptying half time

The gastric emptying half time is the time to empty the half of the ingested solid food in the stomach.

Full Information

NCT ID

NCT01523184

First Posted

January 27, 2012

Last Updated

July 2, 2014

Sponsor

SK Life Science, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01523184

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

March 2012 (undefined)

Primary Completion Date

November 2013 (Actual)

Study Completion Date

November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SK Life Science, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Constipation, Functional Constipation

Keywords

Chronic constipation (CC), Functional Constipation (FC), Gastric Emptying, Colon Transit, multiple doses of YKP10811, gastrointestinal transit, colonic transit

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

57 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo Capsule

Arm Type

Placebo Comparator

Arm Description

Placebo Capsules

Arm Title

YKP10811 Drug Product Capsule, 10 mg

Arm Type

Active Comparator

Arm Title

YKP10811 Drug Product Capsule, 20 mg

Arm Type

Active Comparator

Arm Title

YKP10811 Drug Product Capsule, 30 mg

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Placebo Capsule

Intervention Description

This is the placebo capsule

Intervention Type

Drug

Intervention Name(s)

YKP10811 Drug Product Capsule

Intervention Description

The drug product, YKP10811, 10 mg under investigation

Intervention Type

Drug

Intervention Name(s)

YKP10811 Drug Product Capsule

Intervention Description

The drug product, YKP10811, 20 mg under investigation

Intervention Type

Drug

Intervention Name(s)

YKP10811 Drug Product Capsule

Intervention Description

The drug product, YKP10811, 30 mg under investigation

Primary Outcome Measure Information:

Title

Colonic Geometric Center (GC) at 24 hours

Description

The colonic GC at 24 hours is the measurement of the move of the food within the GI track.

Time Frame

48 hours

Secondary Outcome Measure Information:

Title

Gastric emptying half time

Description

The gastric emptying half time is the time to empty the half of the ingested solid food in the stomach.

Time Frame

4 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Camilleri, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

25148765

Citation

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.

Results Reference

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

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