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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: DWP10292; Drug: DWP10292 Placebo; Drug: Ursodeoxycholic acid (UDCA); Drug: UDCA Placebo

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 Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: DWP10292; Drug: DWP10292 DWP10292 tablets, oral administration, multiple administration Arms: DWP10292	Drug: DWP10292; Drug: DWP10292 tablets, oral administration, multiple administration
PLACEBO_COMPARATOR: DWP10292 Placebo; Drug: Placebo Placebo tablets, oral administration, multiple administrations Arms: Placebo	Drug: DWP10292 Placebo; Placebo tablets, oral administration, multiple administrations
EXPERIMENTAL: Ursodeoxycholic acid (UDCA); Drug: Ursodeoxycholic acid (UDCA) UDCA tablets, oral administration, multiple administrations Arms: Ursodeoxycholic acid (UDCA)	Drug: Ursodeoxycholic acid (UDCA); Drug: Ursodeoxycholic acid (UDCA) tablets, oral administration, multiple administration
PLACEBO_COMPARATOR: Ursodeoxycholic acid (UDCA) Placebo; Drug: Placebo Placebo tablets, oral administration, multiple administrations Arms: Placebo	Drug: UDCA Placebo; Placebo tablets, oral administration, multiple administrations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of Pharmacokinetics	Peak Plasma Concentration (Cmax)	Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
Composite of Pharmacokinetics	Area under the plasma concentration versus time curve (AUC)	Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
Composite of Pharmacokinetics	Mean residence time (MRT)	Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
Composite of Pharmacokinetics	Accumulation index	Multiple blood sample will be collected for 24 hours after last dosing in each of the periods

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (ACTUAL): February 1, 2016
• Study Completion (ACTUAL): February 1, 2016

Study Registration Dates

• First Submitted: April 30, 2015
• First Submitted That Met QC Criteria: December 2, 2015
• First Posted (ESTIMATE): December 4, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): June 2, 2016
• Last Update Submitted That Met QC Criteria: June 1, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Agents; Cholagogues and Choleretics; Ursodeoxycholic Acid
• Other Study ID Numbers: DW_P10292002P