Phase I Clinical Trial of DA-6886 in Healthy Male Subjects
Phase 1
Completed
- Conditions
- Irritable Bowel Syndrome
- Interventions
- Registration Number
- NCT01633723
- Lead Sponsor
- Dong-A ST Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 105
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description DA-6886 placebo Placebo of DA-6886 - DA-6886 DA-6886 -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Pharmacokinetics and Pharmacodynamics up to 48 hours after last dosing of DA-6886 Cmax, Tmax, AUClast, Ae, Cssmax, Cssmin
Trial Locations
- Locations (1)
ASAN medical center
🇰🇷Seoul, Songpa-gu, Korea, Republic of