A Single Dose Study of DWP10292 in Healthy Male Subjects

NCT ID: NCT01423526

Last Updated: 2014-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2012-02-29

Brief Summary

The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of orally administrated DWP10292 in healthy male volunteers.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Drug: Placebo tablets, oral administration, single administrations

Arms: Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo tablets, oral administration, single administrations

DWP10292

Drug: DWP10292 tablets, oral administration, single administrations

Arms: DWP10292

Group Type: EXPERIMENTAL

DWP10292

Intervention Type: DRUG

Drug: DWP10292 tablets, oral administration, single administration

Interventions

DWP10292

Drug: DWP10292 tablets, oral administration, single administration

Intervention Type: DRUG

Placebo

Placebo tablets, oral administration, single administrations

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints
• Healthy adult male subjects aged 20 to 45 years
• The subject has a Body weight ≥ 60 kg and < 90 kg and Body Mass Index (BMI) ≥ 18.5 kg/m2 and < 27.0 kg/m2
• 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)

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 ≥140 mmHg or ≤100 mmHg, and the number of diastolic blood pressure of ≥90mmHg or ≤60mmHg
• A subject who shows the following result in clinical laboratory test:

• AST,ALT>1.25 times of the upper limit of normal range
• QTc>430msec
• T.bil>1.25 times of the upper limit of normal range
• A subject from whom over 400mL of blood was sampled(whole blood or plasma donation, etc.) within last 8 weeks
• Subject who has taken other clinical or licensed medication from another clinical trial within an 8-week 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).
• Subject who smokes an average of 10 cigarettes/day and is unable to quit smoking during the clinical trial.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kyung-Sang Yu

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, Korea, South Korea

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

DWP10292

Identifier Type: -

Identifier Source: org_study_id