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

Functional Constipation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02538367
• Other study ID #: YH12852-102
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 21, 2015
• Last updated: October 27, 2016
• Start date: August 2015
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: Yuhan Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Constipation
• Functional Constipation

Intervention

Drug:
• YH12852 IR 0.05mg

• YH12852 IR 0.1mg

• YH12852 IR 0.3mg

• YH12852 IR 0.5mg

• YH12852 IR 1mg

• YH12852 IR 2mg

• YH12852 IR 3mg

• YH12852 DR1 0.5mg

• YH12852 DR1 1mg

• YH12852 DR1 2mg

• YH12852 DR1 4mg

• YH12852 DR2 8mg

• Prucalopride 2mg

• Placebo

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yuhan Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax (IR/DR multiple dose cohort and Multiple low-dose IR cohort)		Day 1 pre-dose (0 hr) ~ 24 hrs post-dose	No
Primary	AUC0-24 (IR/DR multiple dose cohort and Multiple low-dose IR cohort)		Day 1 pre-dose (0 hr) ~ 24 hrs post-dose	No
Primary	Tmax(IR/DR multiple dose cohort and Multiple low-dose IR cohort)		Day 1 pre-dose (0 hr) ~ 24 hrs post-dose	No
Primary	C(IR multiple dose cohort)	CD5, CD10, CD12, CD13	Day 5, 10, 12 and 13	No
Primary	Cmax,ss(IR/DR multiple dose cohort and Multiple low-dose IR cohort)		Day 14	No
Primary	Cmax,ss (DR single dose cohort)		Day 1: pre-dose (0 hr) ~ 62hr and 86 hrs post-dose	No
Primary	AUClast (DR single dose cohort)		Day 1: pre-dose (0 hr) ~ 62hr and 86 hrs post-dose	No
Primary	C(DR multiple dose cohort and Multiple low-dose IR cohort)	CD5, CD13, CD14	Day 5, 13 and 14	No