Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetics of DWP09031
This study is not yet open for participant recruitment.
Verified January 2012 by Daewoong Pharmaceutical Co. LTD.
Sponsor:
Daewoong Pharmaceutical Co. LTD.
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier:
NCT01522586
First received: January 27, 2012
Last updated: January 30, 2012
Last verified: January 2012
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Purpose
The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of orally administrated DWP09031 in healthy male volunteers.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: DWP09031 Drug: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science |
| 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 |
Further study details as provided by Daewoong Pharmaceutical Co. LTD.:
Primary Outcome Measures:
- Safety&tolerability [ Time Frame: -1d, 0 (predose), 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 h, 8d (post-study visit) ] [ Designated as safety issue: Yes ]Adverse events, Physical exam, Vital sign, laboratory(CBC,chemistry,U/A etc)
Secondary Outcome Measures:
- Pharmacokinetics [ Time Frame: 0 (predose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 ,24 ,36, 48 h ] [ Designated as safety issue: Yes ]Cmax, AUClast, AUCinf, t1/2, CL/F, Vd/F
| Estimated Enrollment: | 64 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: DWP09031
DWP09031 50mg/100mg/400mg/200mg/800mg/1200mg/1600mg/2000mg single dosing
|
Drug: DWP09031
DWP09031 50mg/100mg/400mg/200mg/800mg/1200mg/1600mg/2000mg single dosing
|
|
Placebo Comparator: Placebo
placebo comparator 50mg/100mg/400mg/200mg/800mg/1200mg/1600mg/2000mg single dosing
|
Drug: Placebo
placebo comparator 50mg/100mg/400mg/200mg/800mg/1200mg/1600mg/2000mg single dosing
|
Eligibility| Ages Eligible for Study: | 20 Years to 45 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01522586
Locations
| Korea, Republic of | |
| Inje University College of Medicine Busan Paik Hospital | Not yet recruiting |
| Busan, Busanjin-gu, Korea, Republic of, 614-735 | |
| Contact: Jae-Gook Shin, Professor 82-51-890-6709 phshinjg@inje.ac.kr | |
Sponsors and Collaborators
Daewoong Pharmaceutical Co. LTD.
Investigators
| Principal Investigator: | Jae-Gook Shin, Professor | BUSAN PAIK HOSPITAL |
More Information
No publications provided
| Responsible Party: | Daewoong Pharmaceutical Co. LTD. |
| ClinicalTrials.gov Identifier: | NCT01522586 History of Changes |
| Other Study ID Numbers: | DWP09031 |
| Study First Received: | January 27, 2012 |
| Last Updated: | January 30, 2012 |
| Health Authority: | United States: Food and Drug Administration South Korea: Korea Food and Drug Administration (KFDA) |
ClinicalTrials.gov processed this record on May 21, 2013