Clinical trial NCT01423526: A Single Dose Study of DWP10292 in Healthy Male Subjects
Official title: A Dose Block-randomized, Double-blind, Placebo Controlled, Single-dosing, Dose-escalation Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetic Characteristics of DWP10292 After Oral Administration in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2011-08-26
Enrollment: 52
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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


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.

Primary outcomes:
measure: Composite of Pharmacokinetics
timeFrame: 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:
measure: Safety&tolerability
timeFrame: 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)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Korea
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Kyung-Sang Yu
role: PRINCIPAL_INVESTIGATOR
References: