Clinical trial NCT02097043: Phase I Clinical Study to Investigate the Pharmacokinetics and Safety/Tolerability of DA-7218 in Healthy Male Volunteers
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-03-26
Enrollment: 31
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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


Eligibility 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

Primary outcomes:
measure: AUClast
timeFrame: 72 hours
measure: Cmax
timeFrame: 72 hours
Secondary outcomes:
measure: tmax, AUCinf, t1/2, CL/F, Vz/F (F; calculated in group 1)
timeFrame: 72 hours
Other outcomes:
measure: Adverse events (subjective or objective symptoms)
timeFrame: 14 days(group 1), 7 days(group 2,3)
measure: Vital signs
timeFrame: 14 days(group 1), 7 days(group 2,3)
measure: Physical examination
timeFrame: 14 days(group 1), 7 days(group 2,3)
measure: 12-lead ECG
timeFrame: 14 days(group 1), 7 days(group 2,3)
measure: Clinical laboratory tests
timeFrame: 14 days(group 1), 7 days(group 2,3)
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University College of Medicine / Seoul National University Hospital
name: Kyung Sang Yu, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.