Study to Evaluate Drug-Drug Interaction of DWP16001 in Combination With DWC202001 and DWC202002 in Healthy Male Adults

NCT04343547 | Unknown Phase 1

• 1 other identifier: DW_DWP16001104
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate drug-drug interaction by comparing the pharmacokinetics (PK)/pharmacodynamics (PD), safety, and tolerability of single/multiple doses of DWP16001 , DWC202001 and DWC202002 alone or in combination in healthy male adults.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Cmax of DWP16001

  Peak Plasma Concetration

  0-72 hours

• AUClast of DWP16001

  Area under the plasma concentration versus time curve

  0-72 hours

• Cmax,ss of DWC202001 and DWC202002

  Peak Plasma Concetration at steady-state

  0-72 hours

• AUCτ,ss of DWC202001 and DWC202002

  Area under the plasma concentration versus time curve at Tau, steady-state

  0-72 hours

Secondary Outcomes (3)

• Tmax of DWP 16001, DWC202001 and DWC202002

  0-72 hours

• T1/2 of DWP 16001, DWC202001 and DWC202002

  0-72 hours

• CL/F of DWC202001 and DWC202002

  0-72 hours

Study Arms (3)

1

EXPERIMENTAL

Drug: DWP16001

2

EXPERIMENTAL

Drug: DWC202001+DWC202002

Experimental 3

EXPERIMENTAL

Drug: DWP16001+DWC202001+DWC202002

Interventions

DWP16001 DRUG

Tablets, Oral, once daily single dose

1

DWC202001+DWC202002 DRUG

Tablets, Oral, multiple doses of DWC202001 and DWC202002 in combination

2

DWP16001+DWC202001+DWC202002 DRUG

Tablets, Oral, DWP16001 , DWC202001 and DWC202002 in combination

Experimental 3

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male adults ≥ 19 and ≤ 50 years of age at the time of the screening procedure
• kg ≤ body weight ≤ 90.0 kg and 18.0 ≤ body mass index (BMI) ≤ 27.0
• Voluntarily decided to participate in the study and provided written consent prior to the screening procedure after receiving a detailed explanation on this study and fully understanding the information
• Is eligible to participate in the study at the discretion of the investigator by a physical examination, laboratory test, and medical history questionnaire, etc.

You may not qualify if:

• Presence or prior history of a clinically significant hepatic, renal, nervous, respiratory, endocrine, hematologic and oncologic, cardiovascular, urogenital, psychiatric disorder
• Presence or prior history of a gastrointestinal disorder (e.g., gastrointestinal ulcers, gastritis, stomach cramps, gastroesophageal reflux disease, Crohn's disease, etc.), or prior history of gastrointestinal surgery (except for simple appendectomy or hernia surgery) that may affect the safety and PK/PD assessment of the study drug.
• Hypersensitivity to, or history of clinically significant hypersensitivity to drugs including DWP16001 and other drugs of the same class (SGLT2 inhibitors), drugs including gemigliptin and other drugs of the same class, metformin and other drugs (aspirin, antibiotics, etc.)
• Considered ineligible for the study by the investigator for reasons including laboratory test results

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Enavogliflozin

Central Study Contacts

Jin Hyun Choi

CONTACT

82-02-550-8406; jhchoi413@daewoong.co.kr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: April 13, 2020
• Study Start: April 1, 2020
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: April 27, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)