A Single Dose Study of DWP10292 in Healthy Male Subjects

Daewoong Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: DWP10292

Study type: Interventional

Funder types: Industry

Identifiers

NCT01423526

DWP10292

Details and patient eligibility

About

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

Enrollment: 52 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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52 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

DWP10292

Experimental group

Description:

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

Treatment:

Drug: DWP10292