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

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

Interventions

DRUG

YH12852 IR 0.05mg

DRUG

YH12852 IR 0.1mg

DRUG

YH12852 IR 0.3mg

DRUG

YH12852 IR 0.5mg

DRUG

YH12852 IR 1mg

DRUG

YH12852 IR 2mg

DRUG

YH12852 IR 3mg

DRUG

YH12852 DR1 0.5mg

DRUG

YH12852 DR1 1mg

DRUG

YH12852 DR1 2mg

DRUG

YH12852 DR1 4mg

DRUG

YH12852 DR2 8mg

DRUG

Prucalopride 2mg

DRUG

Placebo

Sponsors & Collaborators

• Yuhan Corporation

  lead INDUSTRY

Principal Investigators

• Howard Lee, MD, PhD · Department of Clinical Pharmacology and Therapeutics, Seoul National University Hospital and College of Medicine

Study Design

Allocation

RANDOMIZED

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

19 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-08-31

Primary Completion

2016-09-30

Completion

2016-09-30

Countries

• South Korea

Study Locations