Phase I Clinical Study to Investigate the Pharmacokinetics and Safety/Tolerability of DA-7218 in Healthy Male Volunteers
- Registration Number
- NCT02097043
- Lead Sponsor
- Dong-A ST Co., Ltd.
- Brief Summary
This study is a phase I clinical trial for evaluating the pharmacokinetics and safety/tolerability of DA-7218 in healthy male volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 31
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description [Group 1] DA-7218 DA-7218 200mg, By mouth or orally (PO) \& intravenous(IV) administration [Group 3] DA-7218 DA-7218 600mg, By mouth or orally (PO) administration [Group 1] Placebo Placebo Placebo, By mouth or orally (PO) \& intravenous(IV) administration [Group 2] DA-7218 DA-7218 400mg, By mouth or orally (PO) administration [Group 2] Placebo Placebo Placebo, By mouth or orally (PO) administration [Group 3] Placebo Placebo Placebo, By mouth or orally (PO) administration
- Primary Outcome Measures
Name Time Method Cmax 72 hours AUClast 72 hours Area under the concentration-time curve from time zero to the last quantifiable concentration by linear trapezoidal method
- Secondary Outcome Measures
Name Time Method tmax, AUCinf, t1/2, CL/F, Vz/F (F; calculated in group 1) 72 hours
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of