Clinical trial NCT05500898: Drug-Drug Interaction of DWP16001 in Combination With DWC202204 and DWC202205 in Healthy Male Adults
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2022-08-15
Enrollment: 53
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cmax,ss of DWP16001
timeFrame: [Time Frame: 0-72 hours]
measure: AUCtau,ss of DWP16001
timeFrame: [Time Frame: 0-72 hours]
measure: Cmax,ss of DWC202204 and DWC202205
timeFrame: [Time Frame: 0-24 hours]
measure: AUCtau,ss of DWC202204 and DWC202205
timeFrame: [Time Frame: 0-24 hours]
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: