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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02538367
Recruitment Status : Completed
First Posted : September 2, 2015
Last Update Posted : October 31, 2016
Sponsor:
Information provided by (Responsible Party):
Yuhan Corporation

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Functional Constipation Drug: YH12852 IR 0.05mg Drug: YH12852 IR 0.1mg Drug: YH12852 IR 0.3mg Drug: YH12852 IR 0.5mg Drug: YH12852 IR 1mg Drug: YH12852 IR 2mg Drug: YH12852 IR 3mg Drug: YH12852 DR1 0.5mg Drug: YH12852 DR1 1mg Drug: YH12852 DR1 2mg Drug: YH12852 DR1 4mg Drug: YH12852 DR2 8mg Drug: Prucalopride 2mg Drug: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: 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
Study Start Date : August 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Cmax (IR/DR multiple dose cohort and Multiple low-dose IR cohort) [ Time Frame: Day 1 pre-dose (0 hr) ~ 24 hrs post-dose ]
  2. 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 ]
  3. Tmax(IR/DR multiple dose cohort and Multiple low-dose IR cohort) [ Time Frame: Day 1 pre-dose (0 hr) ~ 24 hrs post-dose ]
  4. C(IR multiple dose cohort) [ Time Frame: Day 5, 10, 12 and 13 ]
    CD5, CD10, CD12, CD13

  5. Cmax,ss(IR/DR multiple dose cohort and Multiple low-dose IR cohort) [ Time Frame: Day 14 ]
  6. Cmax,ss (DR single dose cohort) [ Time Frame: Day 1: pre-dose (0 hr) ~ 62hr and 86 hrs post-dose ]
  7. AUClast (DR single dose cohort) [ Time Frame: Day 1: pre-dose (0 hr) ~ 62hr and 86 hrs post-dose ]
  8. C(DR multiple dose cohort and Multiple low-dose IR cohort) [ Time Frame: Day 5, 13 and 14 ]
    CD5, CD13, CD14



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02538367


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Yuhan Corporation
Investigators
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Principal Investigator: Howard Lee, MD, PhD Department of Clinical Pharmacology and Therapeutics, Seoul National University Hospital and College of Medicine
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Responsible Party: Yuhan Corporation
ClinicalTrials.gov Identifier: NCT02538367    
Other Study ID Numbers: YH12852-102
First Posted: September 2, 2015    Key Record Dates
Last Update Posted: October 31, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive
Prucalopride
YH12852
Laxatives
Gastrointestinal Agents
Serotonin 5-HT4 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs