Pharmacokinetics and Safety/Tolerability Profiles of DA-2811 in Healthy Subjects

Dong-A ST

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: DA-2811; Drug: Forxiga

Study type: Interventional

Funder types: Industry

Identifiers

NCT04473417

DA2811_BE_I

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 4 patient groups

Part A, Sequence I

Experimental group

Description:

Period I: Forxiga® → DA-2811, Period II: DA-2811 → Forxiga®

Treatment:

Drug: DA-2811

Drug: DA-2811

Drug: DA-2811

Drug: Forxiga

Part A, Sequence II

Experimental group

Description:

Period I: DA-2811 → Forxiga®, Period II: Forxiga® → DA-2811

Treatment:

Drug: DA-2811

Drug: DA-2811

Drug: DA-2811

Drug: Forxiga

Part B, Sequence I

Experimental group

Description:

Period I: DA-2811 under fasting state → DA-2811 under fed state, Period II:DA-2811 under fed state → DA-2811 under fasting state

Treatment:

Drug: DA-2811

Drug: DA-2811

Drug: DA-2811

Part B, Sequence II

Experimental group

Description:

Period I: DA-2811 under fed state → DA-2811 under fasting state, Period II: DA-2811 under fasting state → DA-2811 under fed state

Treatment:

Drug: DA-2811

Drug: DA-2811

Drug: DA-2811