Study to Evaluate Drug-Drug Interaction of DWP16001 in Combination With Metformin in Healthy Male Adults (Phase 1 Study)

A Randomized, Open Label, Single / Multiple Dose, Crossover Phase 1, Study to Evaluate Drug-Drug Interaction of DWP16001 in Combination With Metformin in Healthy Male Adults

The purpose of this study is to evaluate drug-drug interaction of DWP16001 in combination with metformin IR 1000mg in Healthy male subjects.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: DWP16001; Drug: Metformin IR; Drug: DWP16001+Metformin IR

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy male adults aged 19 to 50 years at the time of screening test
• 55.0 kg ≤ Body weight ≤ 90.0 kg and 18.0 ≤ Body Mass Index (BMI) ≤ 27.0
• Written consent on voluntary decision of participation prior to the screening procedure after being fully informed of and completely understanding this study
• Eligible to participate in the study at the discretion of the investigator by physical examination, laboratory test, and history taking, etc.

Exclusion Criteria:

• Current or history of clinically significant hepatic, renal, nervous, respiratory, endocrine, hemato-oncology, cardiovascular, urogenital, psychosis disorder
• Current or history of gastrointestinal disorders or prior history of gastrointestinal surgery that may affect safety and PK/PD assessment of the study drug
• Hypersensitivity or medical history of clinically significant hypersensitivity to a drug containing an ingredient of the investigational product (DWP16001), Dapagliflozin, Metformin or similar ingredient or other drugs (e.g., aspirin, antibiotics, etc.)
• Clinical laboratory test values are outside the accepted normal range at screening
• Other exclusive inclusion criteria, as defined in the protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1	Drug: DWP16001; Tablets, Oral, once daily single dose
EXPERIMENTAL: 2	Drug: Metformin IR; Metformin IR 1000mg, Tablets, Oral, BID for 7 days
EXPERIMENTAL: 3	Drug: DWP16001+Metformin IR; Tablets, Oral, once daily single dose DWP16001 Metformin IR 1000mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Metformin	Peak Plasma Concetration at steady-state	0-144 hours
AUCτ,ss of Metformin	Area under the plasma concentration versus time curve at Tau, steady-state	0-144 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tmax of DWP 16001, Metformin, DWP16001 Metabolites	Time at Cmax	0-144 hours
AUC of DWP 16001, Metformin, DWP16001 Metabolites	Area under the plasma concentration versus time curve	0-144 hours
T1/2 of DWP 16001, Metformin		0-144 hours
CL/F of DWP 16001, Metformin	Apparent total clearance of the drug from plasma after oral administration	0-144 hours
fe of DWP 16001, DWP16001 Metabolites	Fraction of the drug excreted into the urine	0-72 hours
CLR of DWP 16001	Renal clearance of the drug from plasma	0-144 hours

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 14, 2019
• Primary Completion (ACTUAL): November 20, 2019
• Study Completion (ACTUAL): November 20, 2019

Study Registration Dates

• First Submitted: August 2, 2019
• First Submitted That Met QC Criteria: August 19, 2019
• First Posted (ACTUAL): August 21, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 13, 2020
• Last Update Submitted That Met QC Criteria: January 8, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: DW_DWP16001102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No