NCT01523184

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 1, 2012

Completed
29 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

July 4, 2014

Status Verified

July 1, 2014

Enrollment Period

1.7 years

First QC Date

January 27, 2012

Last Update Submit

July 2, 2014

Conditions

Chronic ConstipationFunctional Constipation

Keywords

Chronic constipation (CC)Functional Constipation (FC)Gastric EmptyingColon Transitmultiple doses of YKP10811gastrointestinal transitcolonic transit

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Gastric emptying half time

    4 hours

Study Arms (4)

Placebo Capsule

PLACEBO COMPARATOR

Placebo Capsules

Drug: Placebo Capsule

YKP10811 Drug Product Capsule, 10 mg

ACTIVE COMPARATOR
Drug: YKP10811 Drug Product Capsule

YKP10811 Drug Product Capsule, 20 mg

ACTIVE COMPARATOR
Drug: YKP10811 Drug Product Capsule

YKP10811 Drug Product Capsule, 30 mg

ACTIVE COMPARATOR
Drug: YKP10811 Drug Product Capsule

Interventions

Placebo CapsuleDRUG

This is the placebo capsule

Placebo Capsule
YKP10811 Drug Product CapsuleDRUG

The drug product, YKP10811, 10 mg under investigation

YKP10811 Drug Product Capsule, 10 mg

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • 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.

    PMID: 25148765DERIVED

Study Officials

  • Michael Camilleri, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2012

First Posted

February 1, 2012

Study Start

March 1, 2012

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

July 4, 2014

Record last verified: 2014-07

Locations

US(1)