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

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ClinicalTrials.gov Identifier: NCT02097043
Recruitment Status : Completed
First Posted : March 26, 2014
Last Update Posted : December 26, 2019
Sponsor:
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Healthy Drug: DA-7218 Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : May 2014
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. AUClast [ Time Frame: 72 hours ]
    Area under the concentration-time curve from time zero to the last quantifiable concentration by linear trapezoidal method

  2. Cmax [ Time Frame: 72 hours ]

Secondary Outcome Measures :
  1. tmax, AUCinf, t1/2, CL/F, Vz/F (F; calculated in group 1) [ Time Frame: 72 hours ]

Other Outcome Measures:
  1. Adverse events (subjective or objective symptoms) [ Time Frame: 14 days(group 1), 7 days(group 2,3) ]
  2. Vital signs [ Time Frame: 14 days(group 1), 7 days(group 2,3) ]
  3. Physical examination [ Time Frame: 14 days(group 1), 7 days(group 2,3) ]
  4. 12-lead ECG [ Time Frame: 14 days(group 1), 7 days(group 2,3) ]
  5. Clinical laboratory tests [ Time Frame: 14 days(group 1), 7 days(group 2,3) ]

Eligibility Criteria
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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02097043


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Dong-A ST Co., Ltd.
Investigators
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Principal Investigator: Kyung Sang Yu, M.D., Ph.D. Seoul National University College of Medicine / Seoul National University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier: NCT02097043    
Other Study ID Numbers: DA7218_PK_I
First Posted: March 26, 2014    Key Record Dates
Last Update Posted: December 26, 2019
Last Verified: December 2019
Additional relevant MeSH terms:
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Tedizolid phosphate
Anti-Bacterial Agents
Anti-Infective Agents