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

NCT02622685 | Completed Phase 1 DMC

• 1 other identifier: DW_P10292002P
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• [Safety & tolerability] Incidence of adverse events related with drug

  4 weeks

Study Arms (4)

DWP10292

EXPERIMENTAL

Drug: DWP10292 DWP10292 tablets, oral administration, multiple administration Arms: DWP10292

Drug: DWP10292

DWP10292 Placebo

PLACEBO COMPARATOR

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

Drug: DWP10292 Placebo

Ursodeoxycholic acid (UDCA)

EXPERIMENTAL

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

Drug: Ursodeoxycholic acid (UDCA)

Ursodeoxycholic acid (UDCA) Placebo

PLACEBO COMPARATOR

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

Drug: UDCA Placebo

Interventions

DWP10292 DRUG

Drug: DWP10292 tablets, oral administration, multiple administration

DWP10292

DWP10292 Placebo DRUG

Placebo tablets, oral administration, multiple administrations

DWP10292 Placebo

Ursodeoxycholic acid (UDCA) DRUG

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

Ursodeoxycholic acid (UDCA)

UDCA Placebo DRUG

Placebo tablets, oral administration, multiple administrations

Ursodeoxycholic acid (UDCA) Placebo

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

MeSH Terms

Interventions

Ursodeoxycholic Acid

Intervention Hierarchy (Ancestors)

Deoxycholic Acid; Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2015
• First Posted: December 4, 2015
• Study Start: May 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: June 2, 2016

Record last verified: 2016-06