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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02538367

Enrollment

120

Registered

2015-09-02

Start date

2015-08-31

Completion date

2016-09-30

Last updated

2016-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Constipation

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

Interventions

DRUGYH12852 IR 0.5mg

DRUGYH12852 IR 0.05mg

DRUGYH12852 IR 0.1mg

DRUGYH12852 IR 0.3mg

DRUGYH12852 IR 1mg

DRUGYH12852 IR 2mg

DRUGYH12852 IR 3mg

DRUGYH12852 DR1 0.5mg

DRUGYH12852 DR1 1mg

DRUGYH12852 DR1 2mg

DRUGYH12852 DR1 4mg

DRUGYH12852 DR2 8mg

DRUGPrucalopride 2mg

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to 60 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Cmax,ss(IR/DR multiple dose cohort and Multiple low-dose IR cohort)	Day 14	—
Cmax,ss (DR single dose cohort)	Day 1: pre-dose (0 hr) ~ 62hr and 86 hrs post-dose	—
Cmax (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	—
Tmax(IR/DR multiple dose cohort and Multiple low-dose IR cohort)	Day 1 pre-dose (0 hr) ~ 24 hrs post-dose	—
C(IR multiple dose cohort)	Day 5, 10, 12 and 13	CD5, CD10, CD12, CD13
AUClast (DR single dose cohort)	Day 1: pre-dose (0 hr) ~ 62hr and 86 hrs post-dose	—
C(DR multiple dose cohort and Multiple low-dose IR cohort)	Day 5, 13 and 14	CD5, CD13, CD14

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026