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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02622685

Enrollment

Registered

2015-12-04

Start date

2015-05-31

Completion date

2016-02-29

Last updated

2016-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGDWP10292

Drug: DWP10292 tablets, oral administration, multiple administration

DRUGDWP10292 Placebo

Placebo tablets, oral administration, multiple administrations

DRUGUrsodeoxycholic acid (UDCA)

Drug: Ursodeoxycholic acid (UDCA) tablets, oral administration, multiple administration

DRUGUDCA Placebo

Placebo tablets, oral administration, multiple administrations

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

MALE

Age

19 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Composite of Pharmacokinetics	Multiple blood sample will be collected for 24 hours after last dosing in each of the periods	Peak Plasma Concentration (Cmax)

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026