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

NCT02538367 | Completed Phase 1

• 1 other identifier: YH12852-102
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Functional Constipation

Outcome Measures

Primary Outcomes (8)

• 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)

  CD5, CD10, CD12, CD13

  Day 5, 10, 12 and 13

• 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

• 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)

  CD5, CD13, CD14

  Day 5, 13 and 14

Study Arms (14)

YH12852 IR 0.05mg

EXPERIMENTAL

Once daily

Drug: YH12852 IR 0.05mg

YH12852 IR 0.1mg

EXPERIMENTAL

Once daily

Drug: YH12852 IR 0.1mg

YH12852 IR 0.3mg

EXPERIMENTAL

Once daily

Drug: YH12852 IR 0.3mg

YH12852 IR 0.5mg

EXPERIMENTAL

Once daily

Drug: YH12852 IR 0.5mg

YH12852 IR 1mg

EXPERIMENTAL

Once daily

Drug: YH12852 IR 1mg

YH12852 IR 2mg

EXPERIMENTAL

Once daily

Drug: YH12852 IR 2mg

YH12852 IR 3mg

EXPERIMENTAL

Once daily

Drug: YH12852 IR 3mg

YH12852 DR1 0.5mg

EXPERIMENTAL

Once daily

Drug: YH12852 DR1 0.5mg

YH12852 DR1 1mg

EXPERIMENTAL

Once daily

Drug: YH12852 DR1 1mg

YH12852 DR1 2mg

EXPERIMENTAL

Once daily

Drug: YH12852 DR1 2mg

YH12852 DR1 4mg

EXPERIMENTAL

Once daily

Drug: YH12852 DR1 4mg

YH12852 DR2 8mg

EXPERIMENTAL

Once daily

Drug: YH12852 DR2 8mg

Prucalopride 2mg

ACTIVE COMPARATOR

Once daily

Drug: Prucalopride 2mg

Placebo

PLACEBO COMPARATOR

Once daily

Drug: Placebo

Interventions

YH12852 IR 0.05mg DRUG

YH12852 IR 0.05mg

YH12852 IR 0.1mg DRUG

YH12852 IR 0.1mg

YH12852 IR 0.3mg DRUG

YH12852 IR 0.3mg

YH12852 IR 0.5mg DRUG

YH12852 IR 0.5mg

YH12852 IR 1mg DRUG

YH12852 IR 1mg

YH12852 IR 2mg DRUG

YH12852 IR 2mg

YH12852 IR 3mg DRUG

YH12852 IR 3mg

YH12852 DR1 0.5mg DRUG

YH12852 DR1 0.5mg

YH12852 DR1 1mg DRUG

YH12852 DR1 1mg

YH12852 DR1 2mg DRUG

YH12852 DR1 2mg

YH12852 DR1 4mg DRUG

YH12852 DR1 4mg

YH12852 DR2 8mg DRUG

YH12852 DR2 8mg

Prucalopride 2mg DRUG

Prucalopride 2mg

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects must be willing and able to provide written informed consent.
• BMI within the range 18 to 25 kg/m2.

You may not qualify if:

• History of positive serologic evidence for infectious disease including HBsAg, anti-HCV, anti-HIV.
• Clinically significant lab/ECG abnormalities in the opinion of the investigator.
• 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.
• WOCBP who are willing to use hormonal methods or hormone-releasing device(e.g., mirena, implanon) for the entire study.
• WOCBP who are pregnant or breastfeeding.
• WOCBP with a positive pregnancy test prior to randomization.
• Males who have not received a vasectomy must agree to use contraceptive methods defined in (a) and refrain from donating sperm throughout the study.
• Presence of uncontrolled or severe medical illness.
• Presence of a disease that require surgery at any time during the study.

Sponsors & Collaborators

• Yuhan Corporation: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

prucalopride

Study Officials

• Howard Lee, MD, PhD

  Department of Clinical Pharmacology and Therapeutics, Seoul National University Hospital and College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2015
• First Posted: September 2, 2015
• Study Start: August 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 31, 2016

Record last verified: 2016-10

Locations

KR (1)