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

Healthy Clinical Trial

Official title:

A Phase I Clinical Trial to Evaluate the Safety and Drug Interactions Between DWP16001 and in Combination With DWC202204 and DWC202205 in Healthy Adult Volunteers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05500898
• Other study ID #: DW_DWP16001108
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: August 26, 2022
• Est. completion date: February 28, 2023

Study information

• Verified date: August 2022
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

• Open label, multiple dose, 2 part, two period, single sequence design. This study is conducted on open label because it evaluates PK/PD parameters that are not affected by the blind. Volunteers who are suitable for the inclusion criteria are granted the final target number before the first dosage, receiving a fixed IP, and conducting a planned clinical trial schedule.

After having a rest period (7 days) in which the drug received is sufficiently metabolized and lost, the IP of the next period is administered.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 53
• Est. completion date: February 28, 2023
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. Healthy male adults = 19 years of age at the time of the screening procedure

2. 18.5 = 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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• DWP16001
Tablets, Oral, multiple doses of DWP16001
• DWC202204+DWC202205
Tablets, Oral, multiple doses of DWC202204 and DWC202205 in combination
• DWP16001+DWC202204+DWC202205
Tablets, Oral, DWP16001 , multiple doses of DWC202204 and DWC202205 in combination

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax,ss of DWP16001	Peak Plasma Concetration at steady-state	[Time Frame: 0-72 hours]
Primary	AUCtau,ss of DWP16001	Area under the plasma concentration versus time curve at Tau, steady-state	[Time Frame: 0-72 hours]
Primary	Cmax,ss of DWC202204 and DWC202205	Peak Plasma Concetration at steady-state	[Time Frame: 0-24 hours]
Primary	AUCtau,ss of DWC202204 and DWC202205	Area under the plasma concentration versus time curve at Tau, steady-state	[Time Frame: 0-24 hours]