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

Healthy Clinical Trial

Official title:

A Dose Block-randomized, Double-blind, Placebo-controlled, Single/Multiple Dosing, Dose-escalation Clinical Phase 1 Trial to Investigate the Safety, Tolerability, and Pharmacokinetics of DWP09031

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01522586
• Other study ID #: DWP09031
• Status: Terminated
• Phase: Phase 1
• First received: January 27, 2012
• Last updated: February 12, 2014
• Start date: January 2012
• Est. completion date: December 2013

Study information

• Verified date: January 2012
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationSouth Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 74
• Est. completion date: December 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• DWP09031
DWP09031 50mg/100mg/400mg/200mg/800mg/1200mg/1600mg/2000mg single dosing
• Placebo
placebo comparator 50mg/100mg/400mg/200mg/800mg/1200mg/1600mg/2000mg single dosing

Locations

Country	Name	City	State
Korea, Republic of	Inje University College of Medicine Busan Paik Hospital	Busan	Busanjin-gu

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety&tolerability	Adverse events, Physical exam, Vital sign, laboratory(CBC,chemistry,U/A etc)	-1d, 0 (predose), 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 h, 8d (post-study visit)	Yes
Secondary	Pharmacokinetics	Cmax, AUClast, AUCinf, t1/2, CL/F, Vd/F	0 (predose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 ,24 ,36, 48 h	Yes