None listed
Conditions
Interventions
Drug : 1. In IR multiple does cohort, 56 subjects will randomly receive YH12852 IR (Immediate Release), prucalopride or placebo for 14 days. The dose for YH12852 IR is 0.3, 0.5, 1, 2, and 3 mg. respec
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
All
Inclusion 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. 3.Males and females between 19 and 60 years of age.
Exclusion criteria
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(Women of Childbearing Potential) who are unwilling or unable to use an adequate contraceptive method to avoid pregnancy for the entire study. WOCBP(Women of Childbearing Potential) 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(Women of Childbearing Potential) who are willing to use hormonal methods or hormone-releasing device(e.g., mirena, implanon) for the entire study. 5.WOCBP(Women of Childbearing Potential) who are pregnant or breastfeeding. 6.WOCBP(Women of Childbearing Potential) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax, AUC0-24 ? Tmax of Day1 ;trough concentrations on Day5, 10, 12, 13, 14 pre-dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Stool assessment;PATIENT ASSESSMENT OF CONSTIPATION-SYMPTOM/PATIENT ASSESSMENT OF GASTROINTESTINAL-SYMPTOM/PATIENT ASSESSMENT OF CONSTIPATION -QUALITY OF LIFE Questionaire | — |
Countries
Korea, Republic of
Contacts
Public Contactseol J Moon
Seoul National University Hospital
Outcome results
None listed