Clinical trial NCT04473417: Pharmacokinetics and Safety/Tolerability Profiles of DA-2811 in Healthy Subjects
Official title: An Open-label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of DA-2811 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-07-16
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is the phase I study to evaluate the pharmacokinetics and safety of DA-2811 and Forxiga® after a single oral dose in healthy volunteers.

The study will also compare the pharmacokinetics and safety profiles of DA-2811 under fasting and fed states in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects
* BMI between 18.5 and 29.9 kg/m2 and weigh at least 50 kg
* Volunteer who totally understands the progress of this clinical trial, make decision by his or her free will, and signed a consent form to follow the progress.

Exclusion Criteria:

* Volunteer who has present or past history of clinically significant cardiovascular, respiratory, urinary, gastrointestinal, hepatic, renal, skin, immunological, musculoskeletal, endocrinal, neurological, psychiatric and/or hematological disease
* Vulnerable to dehydration due to poor oral intake or clinically significant dehydration as judged by the investigator
* History of gastrointestinal disease or any gastrointestinal surgery(except for simple appendectomy, hernia surgery, hemorrhoid surgery)
* History of diseases that may impact absorption, distribution, metabolism, and excretion of the study drugs.
* Hypersensitivity to a drug containing an ingredient of the investigational product, Sodium glucose transporter-2 inhibitors, additional ingredient or other drugs (e.g., aspirin, antibiotics, etc.) or medical history of clinically significant hypersensitivity.
* History of clinically significant active chronic disease
* volunteer who has genetic disorder like lapp lactase deficiency or glucose-galactose malabsorption.
* History of clinically significant allergies including drug allergies
* History of drug abuse or addicted
* Clinical laboratory test values are outside the accepted normal range
* Participation in another clinical trial within 6 months of the first IP administration
* Sexually active women of childbearing potential not consistently and correctly practicing birth control by dual contraceptive method until 2 months after last IP administration
* Breast-feeding period, pregnant, or positive to urine pregnancy test (conducted before the first drug administration)
* Subjects considered as unsuitable based on medical judgement by investigators

Primary outcomes:
measure: AUClast
timeFrame: pre-dose~48 hours post-dose
measure: Cmax
timeFrame: pre-dose~48 hours post-dose
Secondary outcomes:
measure: AUC(0 - ∞)
timeFrame: pre-dose~48 hours post-dose
measure: Tmax
timeFrame: pre-dose~48 hours post-dose
measure: t1/2
timeFrame: pre-dose~48 hours post dose
Other outcomes:
Locations:
city: Sŏngnam
country: Korea, Republic of
facility: Bundangseoul national unversity hospital
state: GyeonggiDo
Study officials:
affiliation: Bundang Seoul National University Hospital Clinical Trial Center
name: JaeYong Chung
role: PRINCIPAL_INVESTIGATOR
References: