NCT02097043

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 26, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

December 26, 2019

Status Verified

December 1, 2019

Enrollment Period

Same day

First QC Date

March 24, 2014

Last Update Submit

December 23, 2019

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • AUClast

    Area under the concentration-time curve from time zero to the last quantifiable concentration by linear trapezoidal method

    72 hours

  • Cmax

    72 hours

Secondary Outcomes (1)

  • tmax, AUCinf, t1/2, CL/F, Vz/F (F; calculated in group 1)

    72 hours

Other Outcomes (5)

  • 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)

  • +2 more other outcomes

Study Arms (6)

[Group 1] DA-7218

EXPERIMENTAL

200mg, By mouth or orally (PO) \& intravenous(IV) administration

Drug: DA-7218

[Group 1] Placebo

PLACEBO COMPARATOR

Placebo, By mouth or orally (PO) \& intravenous(IV) administration

Drug: Placebo

[Group 2] DA-7218

EXPERIMENTAL

400mg, By mouth or orally (PO) administration

Drug: DA-7218

[Group 2] Placebo

PLACEBO COMPARATOR

Placebo, By mouth or orally (PO) administration

Drug: Placebo

[Group 3] DA-7218

EXPERIMENTAL

600mg, By mouth or orally (PO) administration

Drug: DA-7218

[Group 3] Placebo

PLACEBO COMPARATOR

Placebo, By mouth or orally (PO) administration

Drug: Placebo

Interventions

DA-7218DRUG
[Group 1] DA-7218[Group 2] DA-7218[Group 3] DA-7218
PlaceboDRUG
[Group 1] Placebo[Group 2] Placebo[Group 3] Placebo

Eligibility Criteria

Age19 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 28865799DERIVED

MeSH Terms

Interventions

tedizolid phosphate

Study Officials

  • Kyung Sang Yu, M.D., Ph.D.

    Seoul National University College of Medicine / Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2014

First Posted

March 26, 2014

Study Start

May 1, 2014

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

December 26, 2019

Record last verified: 2019-12

Locations

KR(1)