A Double-blind, Placebo-controlled, Randomized, Phase 1 Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Orally Administered DA-7503 After Single and Multiple Ascending Dose Regimens in Healthy Adult and Elderly Participants
Overview
- Phase
- Phase 1
- Intervention
- Placebo Multiple dose
- Conditions
- Healthy
- Sponsor
- Dong-A ST Co., Ltd.
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Pharmacokinetics of DA-7503 multiple dose oral administration
- Status
- Not Yet Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
This is a double-blind, placebo-controlled, randomized, phase 1 study to evaluate safety, tolerability, and pharmacokinetics of orally administered DA-7503 after single and multiple ascending dose regimens in healthy adult and elderly participants
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy volunteers(Age: 19\~55 years, 65\~85 years)
- •Body weight≥50.0kg, 18.0kg/m²≤BMI≤30.0kg/m²
Exclusion Criteria
- •Clinically significant Medical History
- •Allergy or Drug hypersensitivity
- •AST, ALT, Total billurbin \> Upper Normal Range\*1.5, eGFR\<60mL/min/1.73m²
- •Positive for serum test results(hepatitis B, hepatitis C, HIV, syphilis test)
- •Heavy smoker(more than 10 cigarettes/day)
- •Heavy caffeine intake(more than 5 units/day)
- •Heavy alcohol intake(more than 210g/week)
Arms & Interventions
[Multiple dose] Placebo
2 subjects in each Cohort(Cohort 1-4)
Intervention: Placebo Multiple dose
[Single dose] DA-7503
6 subjects in each Cohort(Cohort 1-5)
Intervention: DA-7503 Single dose
[Single dose] Placebo
2 subjects in each Cohort(Cohort 1-5)
Intervention: Placebo Single dose
[Multiple dose] DA-7503
6 subjects in each Cohort(Cohort 1-4)
Intervention: DA-7503 Multiple dose
Outcomes
Primary Outcomes
Pharmacokinetics of DA-7503 multiple dose oral administration
Time Frame: 11 days
Area under the plasma concentration versus time curve of tau in steady state (AUCtau,ss)
Pharmacokinetics of DA-7503 single dose oral administration
Time Frame: 5 days
Area under the plasma concentration versus time curve of DA-7503 (AUClast)