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

Healthy Clinical Trial

— DA-2811  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04473417
• Other study ID #: DA2811_BE_I
• Status: Completed
• Phase: Phase 1
• Start date: August 4, 2020
• Est. completion date: October 12, 2020

Study information

• Verified date: March 2021
• Source: Dong-A ST Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 12, 2020
• Est. primary completion date: August 26, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Forxiga
single dose administration after 10hr fasting
• DA-2811
single dose administration after 10hr fasting
• DA-2811
single dose administration after 10hr fasting
• DA-2811
single dose administration after high fat and calorie fed diet

Locations

Country	Name	City	State
Korea, Republic of	Bundangseoul national unversity hospital	Songnam	GyeonggiDo

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUClast	Area under the plasma concentration-time curve from time zero to time the last quantifiable time	pre-dose~48 hours post-dose
Primary	Cmax	Maximum plasma concentration	pre-dose~48 hours post-dose
Secondary	AUC(0 - 8)	Area under the plasma concentration versus time curve from time zero to extrapolated infinite time (0 - 8)	pre-dose~48 hours post-dose
Secondary	Tmax	Time to reach maximum plasma concentration following drug administration	pre-dose~48 hours post-dose
Secondary	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