A Multiple Dose Study of DWP10292 and UDCA in Healthy Male Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: DWP10292; Drug: DWP10292 Placebo; Drug: Ursodeoxycholic acid (UDCA); Drug: UDCA Placebo

• Registration Number: NCT02622685
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

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.

Study Timeline

• Study First Submitted: 2015-04-30
• Study Start: 2015-05
• Study First Submitted QC: 2015-12-02
• Study First Posted: 2015-12-04
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-01
• Last Update Posted: 2016-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DWP10292	DWP10292	Drug: DWP10292 DWP10292 tablets, oral administration, multiple administration Arms: DWP10292
DWP10292 Placebo	DWP10292 Placebo	Drug: Placebo Placebo tablets, oral administration, multiple administrations Arms: Placebo
Ursodeoxycholic acid (UDCA)	Ursodeoxycholic acid (UDCA)	Drug: Ursodeoxycholic acid (UDCA) UDCA tablets, oral administration, multiple administrations Arms: Ursodeoxycholic acid (UDCA)
Ursodeoxycholic acid (UDCA) Placebo	UDCA Placebo	Drug: Placebo Placebo tablets, oral administration, multiple administrations Arms: Placebo

Primary Outcome Measures

Name	Time	Method
Composite of Pharmacokinetics	Multiple blood sample will be collected for 24 hours after last dosing in each of the periods	Accumulation index

Secondary Outcome Measures

Name	Time	Method
[Safety & tolerability] Incidence of adverse events related with drug	4 weeks	Adverse events, Physical exam, Vital sign, laboratory (CBC, chemistry, U/A etc)