Clinical trial NCT02622685: A Multiple Dose Study of DWP10292 and UDCA in Healthy Male Subjects
Official title: A Dose Block-randomized, Double-blind, Placebo Controlled, Multiple Dosing, Dose-escalation Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of DWP10292 and Ursodeoxycholic Acid 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: 2015-12-04
Enrollment: 58
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of DWP10292 and UDCA in healthy male volunteers after multiple-dosing.

Detailed description: This study is dose block-randomized, double-blind, placebo controlled, multiple-dosing, dose escalation clinical trial to investigate the safety, tolerability and pharmacokinetic characteristics of DWP 10292 after oral administration in healthy male subjects.

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 19 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 donates his blood (whole blood donation within last 2 months or plasma donation within last 1 month) or received a blood transfusion within last 1 month
* Subject who has taken other clinical or licensed medication from another clinical trial within an 3-month 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: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
measure: Composite of Pharmacokinetics
timeFrame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
measure: Composite of Pharmacokinetics
timeFrame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
measure: Composite of Pharmacokinetics
timeFrame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
Secondary outcomes:
measure: [Safety & tolerability] Incidence of adverse events related with drug
timeFrame: 4 weeks
Other outcomes:
Locations:
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