Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetics of DWP09031

Phase 1

Terminated

• Conditions: Healthy
• Interventions: Drug: DWP09031; Drug: Placebo

• Registration Number: NCT01522586
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief Summary

The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of orally administrated DWP09031 in healthy male volunteers.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-01
• Study Start: 2012-01
• Study First Submitted: 2012-01-27
• Study First Submitted QC: 2012-01-30
• Study First Posted: 2012-01-31
• Primary Completion: 2013-05
• Study Completion: 2013-12
• Last Update Submitted: 2014-02-12
• Last Update Posted: 2014-02-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 74

Inclusion Criteria

1. Healthy adult male subjects aged 20 to 45 years
2. The subject has Broca's index ≤ 20%
3. A Subject who was judged to be healthy by the investigator to participate in this study based on screening results (according to standard reference index updated recently)
4. A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints

Exclusion Criteria

1. A subject with sign or symptoms or previously diagnosed disease of liver (viral hepatitis), digestive system, cardiovascular, kidney, respiratory, endocrinology, neurology, immune system, hematology, and psychology function or other significant diseases and history or suspicion of current drug abuse and alcohol abuse

2. A subject who shows vital signs with the number of systolic blood pressure of ≥141 mmHg or ≤89 mmHg, and the number of diastolic blood pressure of ≥91mmHg

3. A subject who shows the following result in clinical laboratory test:

   AST,ALT>1.25 times of the upper limit of normal range PR ≥ 210 msec QRS ≥ 120 msec QT ≥ 500 msec QTcF ≥ 450 msec creatinine clearance ≤ 80mL/min

4. Subject who has taken other clinical or licensed medication from another clinical trial within an 90-day period prior to the first administration of the study medication (The last administration of the medication is considered as an end point of the previous clinical trial).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DWP09031	DWP09031	DWP09031 50mg/100mg/400mg/200mg/800mg/1200mg/1600mg/2000mg single dosing
Placebo	Placebo	placebo comparator 50mg/100mg/400mg/200mg/800mg/1200mg/1600mg/2000mg single dosing

Primary Outcome Measures

Name	Time	Method
Safety&tolerability	-1d, 0 (predose), 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 h, 8d (post-study visit)	Adverse events, Physical exam, Vital sign, laboratory(CBC,chemistry,U/A etc)

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics	0 (predose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 ,24 ,36, 48 h	Cmax, AUClast, AUCinf, t1/2, CL/F, Vd/F

Trial Locations

Locations (1)

Inje University College of Medicine Busan Paik Hospital; 🇰🇷 Busan, Busanjin-gu, Korea, Republic of