Phase 1/2a Trial of YH12852 in Healthy Subjects and Patients With Functional Constipation
- Conditions
- Functional Constipation
- Interventions
- Drug: YH12852 IR 0.1mgDrug: YH12852 DR1 2mgDrug: YH12852 IR 0.05mgDrug: YH12852 IR 0.5mgDrug: YH12852 IR 2mgDrug: YH12852 IR 0.3mgDrug: YH12852 IR 1mgDrug: PlaceboDrug: YH12852 IR 3mgDrug: YH12852 DR1 0.5mgDrug: YH12852 DR1 1mgDrug: YH12852 DR1 4mgDrug: YH12852 DR2 8mg
- Registration Number
- NCT02538367
- Lead Sponsor
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- Subjects must be willing and able to provide written informed consent.
- BMI within the range 18 to 25 kg/m2.
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History of positive serologic evidence for infectious disease including HBsAg, anti-HCV, anti-HIV.
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Clinically significant lab/ECG abnormalities in the opinion of the investigator.
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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.
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WOCBP who are willing to use hormonal methods or hormone-releasing device(e.g., mirena, implanon) for the entire study.
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WOCBP who are pregnant or breastfeeding.
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WOCBP with a positive pregnancy test prior to randomization.
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Males who have not received a vasectomy must agree to use contraceptive methods defined in (a) and refrain from donating sperm throughout the study.
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Presence of uncontrolled or severe medical illness.
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Presence of a disease that require surgery at any time during the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description YH12852 IR 0.1mg YH12852 IR 0.1mg Once daily YH12852 DR1 2mg YH12852 DR1 2mg Once daily YH12852 IR 0.05mg YH12852 IR 0.05mg Once daily YH12852 IR 0.5mg YH12852 IR 0.5mg Once daily YH12852 IR 2mg YH12852 IR 2mg Once daily YH12852 IR 0.3mg YH12852 IR 0.3mg Once daily YH12852 IR 1mg YH12852 IR 1mg Once daily Placebo Placebo Once daily YH12852 IR 3mg YH12852 IR 3mg Once daily YH12852 DR1 0.5mg YH12852 DR1 0.5mg Once daily YH12852 DR1 1mg YH12852 DR1 1mg Once daily YH12852 DR1 4mg YH12852 DR1 4mg Once daily Prucalopride 2mg Prucalopride 2mg Once daily YH12852 DR2 8mg YH12852 DR2 8mg Once daily
- Primary Outcome Measures
Name Time Method AUClast (DR single dose cohort) Day 1: pre-dose (0 hr) ~ 62hr and 86 hrs post-dose C(IR multiple dose cohort) Day 5, 10, 12 and 13 CD5, CD10, CD12, CD13
Tmax(IR/DR multiple dose cohort and Multiple low-dose IR cohort) Day 1 pre-dose (0 hr) ~ 24 hrs post-dose AUC0-24 (IR/DR multiple dose cohort and Multiple low-dose IR cohort) Day 1 pre-dose (0 hr) ~ 24 hrs post-dose Cmax,ss(IR/DR multiple dose cohort and Multiple low-dose IR cohort) Day 14 C(DR multiple dose cohort and Multiple low-dose IR cohort) Day 5, 13 and 14 CD5, CD13, CD14
Cmax (IR/DR multiple dose cohort and Multiple low-dose IR cohort) Day 1 pre-dose (0 hr) ~ 24 hrs post-dose Cmax,ss (DR single dose cohort) Day 1: pre-dose (0 hr) ~ 62hr and 86 hrs post-dose
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of