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

NCT01522586 | Terminated Phase 1 DMC

• 1 other identifier: DWP09031
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• Pharmacokinetics

  0 (predose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 ,24 ,36, 48 h

Study Arms (2)

DWP09031

EXPERIMENTAL

DWP09031 50mg/100mg/400mg/200mg/800mg/1200mg/1600mg/2000mg single dosing

Drug: DWP09031

Placebo

PLACEBO COMPARATOR

placebo comparator 50mg/100mg/400mg/200mg/800mg/1200mg/1600mg/2000mg single dosing

Drug: Placebo

Interventions

DWP09031 DRUG

DWP09031 50mg/100mg/400mg/200mg/800mg/1200mg/1600mg/2000mg single dosing

DWP09031

Placebo DRUG

placebo comparator 50mg/100mg/400mg/200mg/800mg/1200mg/1600mg/2000mg single dosing

Placebo

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult male subjects aged 20 to 45 years
• The subject has Broca's index ≤ 20%
• 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)
• A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints

You may not qualify if:

• 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
• 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
• 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
• 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).

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

Study Sites (1)

Inje University College of Medicine Busan Paik Hospital

Busan, Busanjin-gu, 614-735, South Korea

Location

Study Officials

• Jae-Gook Shin, Professor

  BUSAN PAIK HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2012
• First Posted: January 31, 2012
• Study Start: January 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 13, 2014

Record last verified: 2012-01

Locations

KR (1)