This study is a multiple ascending dose study to Assess the Safety, Tolerability, and Pharmacokinetics of orally dosed PG 760564 Administered Twice Daily to Healthy Male and Female Volunteers for 14 Days (27 Doses).
This study is a multiple ascending dose study to Assess the Safety, Tolerability, and Pharmacokinetics of orally dosed PG 760564 Administered Twice Daily to Healthy Male and Female Volunteers for 14 Days (27 Doses). The study is a multiple rising dose (MRD) study of active drug vs. placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
45
Stuart I Harris, MD, PhD
Miami, Florida, United States
AUCτ Over a Dosing Interval (τ = 12 Hours) on Day 14
the area under the plasma concentration-time curve over a dosing interval (τ = 12 hours) on Day 14 of Multiple Dose Oral Administration of PG-760564 Given Every 12 Hours
Time frame: 14 days
Cmax Over a Dosing Interval (τ = 12 Hours)on Day 14
Maximum plasma concentration (Cmax) over a dosing interval (τ = 12 hours)on Day 14
Time frame: 12 hours on Day 14
Tmax Over a Dosing Interval (τ = 12 Hours) on Day 14
the time at which maximum plasma concentration occurred (Tmax) Over a Dosing Interval (τ = 12 Hours) on Day 14
Time frame: 12 Hours on Day 14
t½,z Over a Dosing Interval (τ = 12 Hours)on Day 14
t½,z is the terminal exponential half-life; over a Dosing Interval (τ = 12 Hours)on Day 14
Time frame: over a Dosing Interval (τ = 12 Hours) on Day 14
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oral capsule, 200 mg, 2x/day for 14 days
oral capsule, 400 mg, 2x/day for 14 days