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

Daewoong Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: DWP10292; Drug: UDCA Placebo; Drug: Ursodeoxycholic acid (UDCA); Drug: DWP10292 Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02622685

DW_P10292002P

Details and patient eligibility

About

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

Full 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.

Enrollment: 58 patients

Sex: Male

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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58 participants in 4 patient groups, including a placebo group

DWP10292

Experimental group

Description:

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

Treatment:

Drug: DWP10292

DWP10292 Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: DWP10292 Placebo

Ursodeoxycholic acid (UDCA)

Experimental group

Description:

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

Treatment:

Drug: Ursodeoxycholic acid (UDCA)

Ursodeoxycholic acid (UDCA) Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: UDCA Placebo