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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02097043

Enrollment

Registered

2014-03-26

Start date

2014-05-31

Completion date

2014-05-31

Last updated

2019-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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

Interventions

DRUGDA-7218

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

19 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Other

Measure	Time frame
12-lead ECG	14 days(group 1), 7 days(group 2,3)
Adverse events (subjective or objective symptoms)	14 days(group 1), 7 days(group 2,3)
Clinical laboratory tests	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)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026