Clinical trial NCT02538367: Phase 1/2a Trial of YH12852 in Healthy Subjects and Patients With Functional Constipation
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Functional Constipation
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2015-09-02
Enrollment: 120
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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


Eligibility 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.

Primary outcomes:
measure: Cmax (IR/DR multiple dose cohort and Multiple low-dose IR cohort)
timeFrame: Day 1 pre-dose (0 hr) ~ 24 hrs post-dose
measure: AUC0-24 (IR/DR multiple dose cohort and Multiple low-dose IR cohort)
timeFrame: Day 1 pre-dose (0 hr) ~ 24 hrs post-dose
measure: Tmax(IR/DR multiple dose cohort and Multiple low-dose IR cohort)
timeFrame: Day 1 pre-dose (0 hr) ~ 24 hrs post-dose
measure: C(IR multiple dose cohort)
timeFrame: Day 5, 10, 12 and 13
measure: Cmax,ss(IR/DR multiple dose cohort and Multiple low-dose IR cohort)
timeFrame: Day 14
measure: Cmax,ss (DR single dose cohort)
timeFrame: Day 1: pre-dose (0 hr) ~ 62hr and 86 hrs post-dose
measure: AUClast (DR single dose cohort)
timeFrame: Day 1: pre-dose (0 hr) ~ 62hr and 86 hrs post-dose
measure: C(DR multiple dose cohort and Multiple low-dose IR cohort)
timeFrame: Day 5, 13 and 14
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Department of Clinical Pharmacology and Therapeutics, Seoul National University Hospital and College of Medicine
name: Howard Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: