Drug-Drug Interaction of DWP16001 in Combination With DWC202204 and DWC202205 in Healthy Male Adults

NCT05500898 | Unknown Phase 1

• 1 other identifier: DW_DWP16001108
• Study Type: interventional
• Target: 53
• Locations: 0 countries
• Sites: N/A

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 , DWC202204 and DWC202205 alone or in combination in healthy male adults.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Cmax,ss of DWP16001

  Peak Plasma Concetration at steady-state

  [Time Frame: 0-72 hours]

• AUCtau,ss of DWP16001

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

  [Time Frame: 0-72 hours]

• Cmax,ss of DWC202204 and DWC202205

  Peak Plasma Concetration at steady-state

  [Time Frame: 0-24 hours]

• AUCtau,ss of DWC202204 and DWC202205

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

  [Time Frame: 0-24 hours]

Study Arms (3)

Experimental 1

EXPERIMENTAL

Drug: DWP16001

Experimental 2

EXPERIMENTAL

Drug: DWC202204+DWC202205

Experimental 3

EXPERIMENTAL

Drug: DWP16001+DWC202204+DWC202205

Interventions

DWP16001 DRUG

Tablets, Oral, multiple doses of DWP16001

Experimental 1

DWC202204+DWC202205 DRUG

Tablets, Oral, multiple doses of DWC202204 and DWC202205 in combination

Experimental 2

DWP16001+DWC202204+DWC202205 DRUG

Tablets, Oral, DWP16001 , multiple doses of DWC202204 and DWC202205 in combination

Experimental 3

Eligibility Criteria

• Age: 19 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male adults ≥ 19 years of age at the time of the screening procedure
• ≤ 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

MeSH Terms

Interventions

Enavogliflozin

Study Design

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

Study Record Dates

• First Submitted: August 12, 2022
• First Posted: August 15, 2022
• Study Start: August 26, 2022
• Primary Completion: October 31, 2022
• Study Completion: February 28, 2023
• Last Updated: August 15, 2022

Record last verified: 2022-08