Clinical trial NCT05574374: Drug-drug Interactions Between DWP14012 and DWC202202 in Healthy Subjects
Official title: A Randomized, Open-label, Three-sequence, Three-period, Multiple Dosing Crossover, Phase 1 Clinical Trial to Evaluate the Effect of DWP14012 on the Pharmacodynamics of DWC202202 in Combination With DWP14012 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Drug Drug Interaction
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2022-10-10
Enrollment: 36
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A randomized, open-label, three-sequence, three-period, multiple dosing crossover, phase 1 clinical trial to evaluate the effect of DWP14012 on the pharmacodynamics of DWC202202 in combination with DWP14012 in healthy subjects


Eligibility criteria: Inclusion Criteria:

* Healthy adults aged ≥ 19 and ≤ 50 years at screening
* Subjects with a body weight ≥ 50.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 kg/m2 to ≤ 27.0 kg/m2 at screening

  ※ BMI (kg/m2) = body weight (kg)/\[height (m)\]2
* Subjects who voluntarily decided to participate in the study and provided written consent to follow precautions after receiving a sufficient explanation on this study and fully understanding the information
* Subjects who are eligible to participate in the study at the discretion of the investigator by physical examination, laboratory tests, and investigator questioning, etc.

Exclusion Criteria:

* Subjects with a history related to blood clotting disorder or bleeding
* Subjects with hypersensitivity or history of clinically significant hypersensitivity to drugs including potassium competitive acid blocker \[P-CAB\] class, aspirin, antibiotics, etc.
* Subjects with a history of drug abuse or a positive result of using abusive drugs in the urine drug screen
* Subjects who participated in other clinical trials (including bioequivalence studies) within 6 months prior to the first scheduled dose of the IP
* Subjects who donated whole blood within 2 months, donated blood components within 1 month, or received blood transfusion within 1 month prior to the first scheduled dose
* Subjects who are unable to refrain from grapefruit-containing products from 3 days prior to the first scheduled dose until last discharge from hospital
* Subjects with hereditary disorders including galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc.
* Subjects or their spouses or partners who are unable to use medically acceptable appropriate double-method of contraception or medically acceptable contraception throughout the study period and for at least 4 weeks after the last IP administration
* Subjects who are smoking

Primary outcomes:
measure: Emax
timeFrame: up to 50 days
measure: AUEC0-24
timeFrame: up to 50 days
Secondary outcomes:
measure: DWC202202 Cmax,ss
timeFrame: up to 50 days
measure: DWC202202 active metabolite Cmax,ss
timeFrame: up to 50 days
measure: DWC202202 AUCtau,ss
timeFrame: up to 50 days
measure: DWC202202 active metabolite AUCtau,ss
timeFrame: up to 50 days
measure: DWC202202 AUCinf,ss
timeFrame: up to 50 days
measure: DWC202202 active metabolite AUCinf,ss
timeFrame: up to 50 days
measure: DWC202202 Tmax,ss
timeFrame: up to 50 days
measure: DWC202202 active metabolite Tmax,ss
timeFrame: up to 50 days
measure: DWC202202 t1/2,ss
timeFrame: up to 50 days
measure: DWC202202 active metabolite t1/2,ss
timeFrame: up to 50 days
measure: DWC202202 Cmin,ss
timeFrame: up to 50 days
measure: DWC202202 active metabolite Cmin,ss
timeFrame: up to 50 days
measure: DWC202202 Cavg,ss
timeFrame: up to 50 days
measure: DWC202202 active metabolite Cavg,ss
timeFrame: up to 50 days
measure: DWC202202 CLss/F
timeFrame: up to 50 days
measure: DWC202202 Vd,ss/F
timeFrame: up to 50 days
measure: DWC202202 PTF (peak to trough fluctuation)
timeFrame: up to 50 days
measure: DWC202202 active metabolite PTF (peak to trough fluctuation)
timeFrame: up to 50 days
measure: DWC202202 R
timeFrame: up to 50 days
measure: DWC202202 active metabolite MR
timeFrame: up to 50 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: