Phase I Clinical Study to Investigate the Pharmacokinetics and Safety/Tolerability of DA-7218 in Healthy Male Volunteers

A Block-randomized, Double-blind, Placebo-controlled, Single-dose, Phase I Clinical Study to Investigate the Pharmacokinetics and Safety/Tolerability of DA-7218 in Healthy Male Volunteers

This study is a phase I clinical trial for evaluating the pharmacokinetics and safety/tolerability of DA-7218 in healthy male volunteers.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: DA-7218

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy male Korean 19-45 years
• Body weight:55-90kg, BMI:18.0-27.0

Exclusion Criteria:

• Present condition or history of any clinically significant disease
• Clinical evidence or history of GI disease or history of GI surgery
• History of hypersensitivities, including drug allergies
• AST (SGOT) or ALT (SGPT) > 1.5 times the upper normal limit
• Systolic blood pressure : <100 mmHg or >160 mmHg
• Diastolic blood pressure : <60 mmHg or >100 mmHg
• Drug abuse within 2 months, or a positive reaction to an abusive drug or cotinine
• Taken any ETC or herbal supplement within 2 weeks or any OTC or vitamin supplement within 1 week
• Participation in and administration of IP of another clinical trial within 2 months
• Donation of whole blood within 2 months, or blood components within 1 month, or receipt of blood transfusion within 1 month
• Consumption of more than 21 units of alcohol/week or inability to abstain from drinking during the study period
• Smoking within 3 months
• Taking caffeine- or grapefruit-containing products within 3 days
• Plan to be pregnant, or not to use an appropriate method of contraception

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: [Group 1] DA-7218; 200mg, By mouth or orally (PO) & intravenous(IV) administration	Drug: DA-7218
PLACEBO_COMPARATOR: [Group 1] Placebo; Placebo, By mouth or orally (PO) & intravenous(IV) administration	Drug: Placebo
EXPERIMENTAL: [Group 2] DA-7218; 400mg, By mouth or orally (PO) administration	Drug: DA-7218
PLACEBO_COMPARATOR: [Group 2] Placebo; Placebo, By mouth or orally (PO) administration	Drug: Placebo
EXPERIMENTAL: [Group 3] DA-7218; 600mg, By mouth or orally (PO) administration	Drug: DA-7218
PLACEBO_COMPARATOR: [Group 3] Placebo; Placebo, By mouth or orally (PO) administration	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax		72 hours
AUClast	Area under the concentration-time curve from time zero to the last quantifiable concentration by linear trapezoidal method	72 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
tmax, AUCinf, t1/2, CL/F, Vz/F (F; calculated in group 1)	72 hours

Other Outcome Measures

Outcome Measure	Time Frame
Adverse events (subjective or objective symptoms)	14 days(group 1), 7 days(group 2,3)
Vital signs	14 days(group 1), 7 days(group 2,3)
Physical examination	14 days(group 1), 7 days(group 2,3)
12-lead ECG	14 days(group 1), 7 days(group 2,3)
Clinical laboratory tests	14 days(group 1), 7 days(group 2,3)

Collaborators and Investigators

• Sponsor: Dong-A ST Co., Ltd.
• Investigators: Principal Investigator: Kyung Sang Yu, M.D., Ph.D., Seoul National University College of Medicine / Seoul National University Hospital

Publications and helpful links

General Publications

• Kim Y, Kim A, Lee S, Choi SH, Lee DY, Song JS, Lee H, Jang IJ, Yu KS. Pharmacokinetics, Safety, and Tolerability of Tedizolid Phosphate After Single-dose Administration in Healthy Korean Male Subjects. Clin Ther. 2017 Sep;39(9):1849-1857. doi: 10.1016/j.clinthera.2017.08.002. Epub 2017 Aug 31.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (ACTUAL): May 1, 2014
• Study Completion (ACTUAL): May 1, 2014

Study Registration Dates

• First Submitted: March 24, 2014
• First Submitted That Met QC Criteria: March 24, 2014
• First Posted (ESTIMATE): March 26, 2014

Study Record Updates

• Last Update Posted (ACTUAL): December 26, 2019
• Last Update Submitted That Met QC Criteria: December 23, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents; Tedizolid phosphate
• Other Study ID Numbers: DA7218_PK_I