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

An Open-label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of DA-2811 in Healthy Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Forxiga; Drug: DA-2811; Drug: DA-2811

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • GyeonggiDo
    • Sŏngnam, GyeonggiDo, Korea, Republic of
      • Bundangseoul national unversity hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A, Sequence I; Period I: Forxiga® → DA-2811, Period II: DA-2811 → Forxiga®	Drug: Forxiga; single dose administration after 10hr fasting; Drug: DA-2811; single dose administration after 10hr fasting; Drug: DA-2811; single dose administration after high fat and calorie fed diet
Experimental: Part A, Sequence II; Period I: DA-2811 → Forxiga®, Period II: Forxiga® → DA-2811	Drug: Forxiga; single dose administration after 10hr fasting; Drug: DA-2811; single dose administration after 10hr fasting; Drug: DA-2811; single dose administration after high fat and calorie fed diet
Experimental: Part B, Sequence I; Period I: DA-2811 under fasting state → DA-2811 under fed state, Period II:DA-2811 under fed state → DA-2811 under fasting state	Drug: DA-2811; single dose administration after 10hr fasting; Drug: DA-2811; single dose administration after high fat and calorie fed diet
Experimental: Part B, Sequence II; Period I: DA-2811 under fed state → DA-2811 under fasting state, Period II: DA-2811 under fasting state → DA-2811 under fed state	Drug: DA-2811; single dose administration after 10hr fasting; Drug: DA-2811; single dose administration after high fat and calorie fed diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUClast	Area under the plasma concentration-time curve from time zero to time the last quantifiable time	pre-dose~48 hours post-dose
Cmax	Maximum plasma concentration	pre-dose~48 hours post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC(0 - ∞)	Area under the plasma concentration versus time curve from time zero to extrapolated infinite time (0 - ∞)	pre-dose~48 hours post-dose
Tmax	Time to reach maximum plasma concentration following drug administration	pre-dose~48 hours post-dose
t1/2	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.	pre-dose~48 hours post dose

Collaborators and Investigators

• Sponsor: Dong-A ST Co., Ltd.
• Investigators: Principal Investigator: JaeYong Chung, Bundang Seoul National University Hospital Clinical Trial Center

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2020
• Primary Completion (Actual): August 26, 2020
• Study Completion (Actual): October 12, 2020

Study Registration Dates

• First Submitted: July 13, 2020
• First Submitted That Met QC Criteria: July 13, 2020
• First Posted (Actual): July 16, 2020

Study Record Updates

• Last Update Posted (Actual): March 5, 2021
• Last Update Submitted That Met QC Criteria: March 3, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; Dapagliflozin
• Other Study ID Numbers: DA2811_BE_I

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No