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NCT Number: NCT02097043

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.

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Key information

Conditions

Healthy

Age range

19 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DA-7218

Drug

Placebo

Drug

Primary outcomes

  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 outcomes

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

    Time frame: 72 hours

Other outcomes

  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)

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Mar 26, 2014
Registry last updated
Dec 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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