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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01633723

Enrollment

105

Registered

2012-07-04

Start date

2012-08-31

Completion date

2014-04-30

Last updated

2021-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome

Brief summary

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.

Interventions

DRUGDA-6886

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)

DRUGPlacebo of DA-6886

DA-6886 placebo

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Assessment of safety	up to 7 days (single dose study, single dose study for food effect), 15 days (multiple dose study)	1. Adverse Events 2. Laboratory Results 3. Vital sign, Physical Examination, EKG

Secondary

Measure	Time frame	Description
Pharmacokinetics and Pharmacodynamics	up to 48 hours after last dosing of DA-6886	Cmax, Tmax, AUClast, Ae, Cssmax, Cssmin

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026