NCT02538367

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
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Yuhan Corporation · Industry
• Sex: All
• Age: 19 Years – 60 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2015-08-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2015-09-02
• Last updated: 2016-10-31

Locations

1 site across 1 country: South Korea