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

Yuhan

Status and phase: Completed; Phase 2; Phase 1

Conditions: Functional Constipation

Treatments: Drug: Placebo; Drug: YH12852 IR 0.3mg; Drug: YH12852 IR 0.5mg; Drug: YH12852 IR 2mg; Drug: YH12852 DR1 0.5mg; Drug: YH12852 IR 1mg; Drug: YH12852 DR1 4mg; Drug: YH12852 DR1 2mg; Drug: YH12852 IR 3mg; Drug: YH12852 IR 0.05mg; Drug: Prucalopride 2mg; Drug: YH12852 IR 0.1mg; Drug: YH12852 DR1 1mg; Drug: YH12852 DR2 8mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02538367

YH12852-102

Details and patient eligibility

About

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

Enrollment: 120 patients

Sex: All

Ages: 19 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

120 participants in 14 patient groups, including a placebo group

YH12852 IR 0.05mg

Experimental group

Description:

Once daily

Treatment:

Drug: YH12852 IR 0.05mg

YH12852 IR 0.1mg

Experimental group

Description:

Once daily

Treatment:

Drug: YH12852 IR 0.1mg

YH12852 IR 0.3mg

Experimental group

Description:

Once daily

Treatment:

Drug: YH12852 IR 0.3mg

YH12852 IR 0.5mg

Experimental group

Description:

Once daily

Treatment:

Drug: YH12852 IR 0.5mg

YH12852 IR 1mg

Experimental group

Description:

Once daily

Treatment:

Drug: YH12852 IR 1mg

YH12852 IR 2mg

Experimental group

Description:

Once daily

Treatment:

Drug: YH12852 IR 2mg

YH12852 IR 3mg

Experimental group

Description:

Once daily

Treatment:

Drug: YH12852 IR 3mg

YH12852 DR1 0.5mg

Experimental group

Description:

Once daily

Treatment:

Drug: YH12852 DR1 0.5mg

YH12852 DR1 1mg

Experimental group

Description:

Once daily

Treatment:

Drug: YH12852 DR1 1mg

YH12852 DR1 2mg

Experimental group

Description:

Once daily

Treatment:

Drug: YH12852 DR1 2mg

YH12852 DR1 4mg

Experimental group

Description:

Once daily

Treatment:

Drug: YH12852 DR1 4mg

YH12852 DR2 8mg

Experimental group

Description:

Once daily

Treatment:

Drug: YH12852 DR2 8mg

Prucalopride 2mg

Active Comparator group

Description:

Once daily

Treatment:

Drug: Prucalopride 2mg

Placebo

Placebo Comparator group

Description:

Once daily

Treatment:

Drug: Placebo