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

Dong-A ST

Status and phase: Completed; Phase 1

Conditions: Irritable Bowel Syndrome

Treatments: Drug: DA-6886; Drug: Placebo of DA-6886

Study type: Interventional

Funder types: Industry

Identifiers

NCT01633723

DA6886_IBS_I

Details and patient eligibility

About

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.

Enrollment: 105 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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105 participants in 2 patient groups, including a placebo group

DA-6886

Experimental group

Treatment:

Drug: DA-6886

DA-6886 placebo

Placebo Comparator group

Treatment:

Drug: Placebo of DA-6886