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

NCT ID: NCT04473417

Last Updated: 2021-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-04
• Study Completion Date: 2020-10-12

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part A, Sequence I

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

Group Type: EXPERIMENTAL

Forxiga

Intervention Type: DRUG

single dose administration after 10hr fasting

DA-2811

Intervention Type: DRUG

single dose administration after 10hr fasting

Part A, Sequence II

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

Group Type: EXPERIMENTAL

Forxiga

Intervention Type: DRUG

single dose administration after 10hr fasting

DA-2811

Intervention Type: DRUG

single dose administration after 10hr fasting

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

Group Type: EXPERIMENTAL

DA-2811

Intervention Type: DRUG

single dose administration after 10hr fasting

DA-2811

Intervention Type: DRUG

single dose administration after high fat and calorie fed diet

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

Group Type: EXPERIMENTAL

DA-2811

Intervention Type: DRUG

single dose administration after 10hr fasting

DA-2811

Intervention Type: DRUG

single dose administration after high fat and calorie fed diet

Interventions

Forxiga

single dose administration after 10hr fasting

Intervention Type: DRUG

DA-2811

single dose administration after 10hr fasting

Intervention Type: DRUG

DA-2811

single dose administration after 10hr fasting

Intervention Type: DRUG

DA-2811

single dose administration after high fat and calorie fed diet

Intervention Type: DRUG

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dong-A ST Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

JaeYong Chung

Role: PRINCIPAL_INVESTIGATOR

Bundang Seoul National University Hospital Clinical Trial Center

Locations

Bundangseoul national unversity hospital

Sŏngnam, GyeonggiDo, South Korea

Countries

South Korea

Other Identifiers

DA2811_BE_I

Identifier Type: -

Identifier Source: org_study_id