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

NCT ID: NCT02097043

Last Updated: 2019-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-05-31

Brief Summary

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

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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[Group 1] DA-7218

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

Group Type EXPERIMENTAL

DA-7218

Intervention Type DRUG

[Group 1] Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

[Group 2] DA-7218

400mg, By mouth or orally (PO) administration

Group Type EXPERIMENTAL

DA-7218

Intervention Type DRUG

[Group 2] Placebo

Placebo, By mouth or orally (PO) administration

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

[Group 3] DA-7218

600mg, By mouth or orally (PO) administration

Group Type EXPERIMENTAL

DA-7218

Intervention Type DRUG

[Group 3] Placebo

Placebo, By mouth or orally (PO) administration

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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DA-7218

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Dong-A ST Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kyung Sang Yu, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University College of Medicine / Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 28865799 (View on PubMed)

Other Identifiers

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DA7218_PK_I

Identifier Type: -

Identifier Source: org_study_id