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

Phase 1

• Conditions: Healthy
• Interventions: Drug: DWP16001+DWC202001+DWC202002; Drug: DWC202001+DWC202002; Drug: DWP16001

• Registration Number: NCT04343547
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-04
• Study Start: 2020-04
• Study First Submitted: 2020-04-10
• Study First Submitted QC: 2020-04-10
• Study First Posted: 2020-04-13
• Last Update Submitted: 2020-04-23
• Last Update Posted: 2020-04-27
• Primary Completion: 2020-07
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 34

Inclusion Criteria

1. Healthy male adults ≥ 19 and ≤ 50 years of age at the time of the screening procedure
2. 55.0 kg ≤ body weight ≤ 90.0 kg and 18.0 ≤ body mass index (BMI) ≤ 27.0
3. 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
4. Is eligible to participate in the study at the discretion of the investigator by a physical examination, laboratory test, and medical history questionnaire, etc.

Exclusion Criteria

1. Presence or prior history of a clinically significant hepatic, renal, nervous, respiratory, endocrine, hematologic and oncologic, cardiovascular, urogenital, psychiatric disorder
2. 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.
3. 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.)
4. Considered ineligible for the study by the investigator for reasons including laboratory test results

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Experimental 3	DWP16001+DWC202001+DWC202002	-
2	DWC202001+DWC202002	-
1	DWP16001	-

Primary Outcome Measures

Name	Time	Method
Cmax of DWP16001	0-72 hours	Peak Plasma Concetration
AUCτ,ss of DWC202001 and DWC202002	0-72 hours	Area under the plasma concentration versus time curve at Tau, steady-state
Cmax,ss of DWC202001 and DWC202002	0-72 hours	Peak Plasma Concetration at steady-state
AUClast of DWP16001	0-72 hours	Area under the plasma concentration versus time curve

Secondary Outcome Measures

Name	Time	Method
T1/2 of DWP 16001, DWC202001 and DWC202002	0-72 hours
CL/F of DWC202001 and DWC202002	0-72 hours
Tmax of DWP 16001, DWC202001 and DWC202002	0-72 hours	Time at Cmax

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of