A Single Dose Study of DWP10292 in Healthy Male Subjects

NCT01423526 | Completed Phase 1 DMC

• 1 other identifier: DWP10292
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Composite of Pharmacokinetics

  Cmax, AUClast, AUCinf, Tmax, t1/2, CL/F

  0 (predose), 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 24 (2d 0h), 36, 48 (3d 0h), 60, 72 (4d 0h), 96 h(5d 0h) and Post study visit 216h (10d 0h)

Secondary Outcomes (1)

• Safety&tolerability

  0 (predose), 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 24 (2d 0h), 36, 48 (3d 0h), 60, 72 (4d 0h), 96 h(5d 0h) Post study visit 216h (10d 0h)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo tablets, oral administration, single administrations Arms: Placebo

Drug: Placebo

DWP10292

EXPERIMENTAL

Drug: DWP10292 tablets, oral administration, single administrations Arms: DWP10292

Drug: DWP10292

Interventions

DWP10292 DRUG

Drug: DWP10292 tablets, oral administration, single administration

DWP10292

Placebo DRUG

Placebo tablets, oral administration, single administrations

Placebo

Eligibility Criteria

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

You may qualify if:

• 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)

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 ≥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.

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

Study Sites (2)

Seoul National University Hospital

Seoul, Korea, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Study Officials

• Kyung-Sang Yu

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 24, 2011
• First Posted: August 26, 2011
• Study Start: August 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: February 25, 2014

Record last verified: 2011-08

Locations

KR (2)