Phase 1/2a Trial of YH12852 in Healthy Subjects and Patients With Functional Constipation

October 27, 2016 updated by: Yuhan Corporation

A Randomized, Double-blind/Open-label, Placebo/Active-controlled, Single/Multiple Dose, Parallel, Phase 1/2a Trial to Evaluate the Safety, Tolerability, PK , PD of YH12852 in Healthy Subjects and Patients With Functional Constipation

A randomized, double-blind/open-label, placebo/active-controlled, single/multiple dose, parallel, phase 1/2a trial to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of YH12852 in healthy subjects and patients with functional constipation

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subjects must be willing and able to provide written informed consent.
  2. BMI within the range 18 to 25 kg/m2.

Exclusion Criteria:

  1. History of positive serologic evidence for infectious disease including HBsAg, anti-HCV, anti-HIV.
  2. Clinically significant lab/ECG abnormalities in the opinion of the investigator.

  3. WOCBP who are unwilling or unable to use an adequate contraceptive method to avoid pregnancy for the entire study. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, bilateral tubectomy, or bilateral oophorectomy) or is not postmenopausal. Post menopause is defined as amenorrhea for ≥ 12 consecutive months without another cause.

    Clinically acceptable contraceptive methods for this study: intrauterine devices (e.g., loop), physical barrier method (e.g., diaphragm, uterine cap, condom) with chemical barrier method (e.g., spermicide), sterile partner, practicing abstinence.

  4. WOCBP who are willing to use hormonal methods or hormone-releasing device(e.g., mirena, implanon) for the entire study.
  5. WOCBP who are pregnant or breastfeeding.
  6. WOCBP with a positive pregnancy test prior to randomization.
  7. Males who have not received a vasectomy must agree to use contraceptive methods defined in (a) and refrain from donating sperm throughout the study.
  8. Presence of uncontrolled or severe medical illness.
  9. Presence of a disease that require surgery at any time during the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: YH12852 IR 0.05mg
Once daily
Drug: YH12852 IR 0.05mg
Experimental: YH12852 IR 0.1mg
Once daily
Drug: YH12852 IR 0.1mg
Experimental: YH12852 IR 0.3mg
Once daily
Drug: YH12852 IR 0.3mg
Experimental: YH12852 IR 0.5mg
Once daily
Drug: YH12852 IR 0.5mg
Experimental: YH12852 IR 1mg
Once daily
Drug: YH12852 IR 1mg
Experimental: YH12852 IR 2mg
Once daily
Drug: YH12852 IR 2mg
Experimental: YH12852 IR 3mg
Once daily
Drug: YH12852 IR 3mg
Experimental: YH12852 DR1 0.5mg
Once daily
Drug: YH12852 DR1 0.5mg
Experimental: YH12852 DR1 1mg
Once daily
Drug: YH12852 DR1 1mg
Experimental: YH12852 DR1 2mg
Once daily
Drug: YH12852 DR1 2mg
Experimental: YH12852 DR1 4mg
Once daily
Drug: YH12852 DR1 4mg
Experimental: YH12852 DR2 8mg
Once daily
Drug: YH12852 DR2 8mg
Active Comparator: Prucalopride 2mg
Once daily
Drug: Prucalopride 2mg
Placebo Comparator: Placebo
Once daily
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cmax (IR/DR multiple dose cohort and Multiple low-dose IR cohort)
Time Frame: Day 1 pre-dose (0 hr) ~ 24 hrs post-dose
Day 1 pre-dose (0 hr) ~ 24 hrs post-dose
AUC0-24 (IR/DR multiple dose cohort and Multiple low-dose IR cohort)
Time Frame: Day 1 pre-dose (0 hr) ~ 24 hrs post-dose
Day 1 pre-dose (0 hr) ~ 24 hrs post-dose
Tmax(IR/DR multiple dose cohort and Multiple low-dose IR cohort)
Time Frame: Day 1 pre-dose (0 hr) ~ 24 hrs post-dose
Day 1 pre-dose (0 hr) ~ 24 hrs post-dose
C(IR multiple dose cohort)
Time Frame: Day 5, 10, 12 and 13
CD5, CD10, CD12, CD13
Day 5, 10, 12 and 13
Cmax,ss(IR/DR multiple dose cohort and Multiple low-dose IR cohort)
Time Frame: Day 14
Day 14
Cmax,ss (DR single dose cohort)
Time Frame: Day 1: pre-dose (0 hr) ~ 62hr and 86 hrs post-dose
Day 1: pre-dose (0 hr) ~ 62hr and 86 hrs post-dose
AUClast (DR single dose cohort)
Time Frame: Day 1: pre-dose (0 hr) ~ 62hr and 86 hrs post-dose
Day 1: pre-dose (0 hr) ~ 62hr and 86 hrs post-dose
C(DR multiple dose cohort and Multiple low-dose IR cohort)
Time Frame: Day 5, 13 and 14
CD5, CD13, CD14
Day 5, 13 and 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yuhan Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Howard Lee, MD, PhD, Department of Clinical Pharmacology and Therapeutics, Seoul National University Hospital and College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 2, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 31, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • YH12852-102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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