Skip to main content
OpenTrials
Completed

NCT Number: NCT01633723

Phase I Clinical Trial of DA-6886 in Healthy Male Subjects

DA-6886_IBS_I is a phase I, dose block-randomized, double-blind, placebo-controlled, single/multiple dosing, dose escalation clinical trial with open-labelled food effect study of single dose to investigate the safety, tolerability and pharmacokinetics of DA-6886 after oral administration in healthy male subjects.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

ASAN medical center

Seoul, Songpa-gu, 138-736, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 20 ~ 45 years old
  • 27kg/m2 ≥ BMI ≥ 20kg/m2
  • Healthy Male
  • Informed consent

Exclusion criteria

  • Clinically significant medical history
  • smokers
  • Clinically significant hypersensitivity of Drugs
  • Clinically significant cutaneous disorder
  • QTcB > 450msec
  • have a history of drug abuse or show positive for drug abuse or cotinine at urine screening

Treatment and study plan

DA-6886

Drug

single dose study : DA-6886 1mg,2.5mg,5mg,10mg,20mg dosage (Dose-escalation)

multiple dose study : DA-6886 2.5mg,5mg,10mg or 5mg,10mg,20mg dosage (Dose-escalation)

Placebo of DA-6886

Drug

DA-6886 placebo

Primary outcomes

  1. Assessment of safety

    Time frame: up to 7 days (single dose study, single dose study for food effect), 15 days (multiple dose study)

    • Adverse Events
    • Laboratory Results
    • Vital sign, Physical Examination, EKG

Secondary outcomes

  1. Pharmacokinetics and Pharmacodynamics

    Time frame: up to 48 hours after last dosing of DA-6886

    Cmax, Tmax, AUClast, Ae, Cssmax, Cssmin

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study title

A Phase I, Dose Block-randomized, Double-blind, Placebo-controlled, Single/Multiple Dosing, Dose Escalation Clinical Trial With Open-labelled Food Effect Study of Single Dose to Investigate the Safety, Tolerability and Pharmacokinetics of DA-6886 After Oral Administration in Healthy Male Subjects

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 4, 2012
Registry last updated
Apr 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.