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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Dong-A ST Co., Ltd.
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- AUClast
Study Overview
Brief Summary
This study is a phase I clinical trial for evaluating the pharmacokinetics and safety/tolerability of DA-7218 in healthy male volunteers.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to 45 Years (Adult)
- Sex
- Male
- Accepts 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
Arms & Interventions
[Group 1] DA-7218
200mg, By mouth or orally (PO) & intravenous(IV) administration
Intervention: DA-7218 (Drug)
[Group 1] Placebo
Placebo, By mouth or orally (PO) & intravenous(IV) administration
Intervention: Placebo (Drug)
[Group 2] DA-7218
400mg, By mouth or orally (PO) administration
Intervention: DA-7218 (Drug)
[Group 2] Placebo
Placebo, By mouth or orally (PO) administration
Intervention: Placebo (Drug)
[Group 3] DA-7218
600mg, By mouth or orally (PO) administration
Intervention: DA-7218 (Drug)
[Group 3] Placebo
Placebo, By mouth or orally (PO) administration
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
AUClast
Time Frame: 72 hours
Area under the concentration-time curve from time zero to the last quantifiable concentration by linear trapezoidal method
Cmax
Time Frame: 72 hours
Secondary Outcomes
- tmax, AUCinf, t1/2, CL/F, Vz/F (F; calculated in group 1)(72 hours)