Safety and Pharmacokinetics of Two Doses of PT010 in Healthy Adult Subjects of Japanese Descent Following a Single Dose and After Chronic Dosing for 7 Days.
This is a Phase I, single-center, randomized, double-blind, placebo-controlled, two period, ascending dose, cross-over study to assess safety and PK of two doses of PT010 in healthy adult subjects of Japanese descent. Safety and PK will be assessed following a single dose and during twice-daily (BID) chronic dosing for 7 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
20
PT010 Dose 1; Budesonide, Glycopyrrolate, and Formoterol Fumarate (BGF) Inhalation Aerosol. Administered as 2 inhalations.
PT010 Dose 2; Budesonide, Glycopyrrolate, and Formoterol Fumarate (BGF) Inhalation Aerosol. Administered as 2 inhalations.
Placebo MDI. Administered as 2 inhalations
SNBL Clinical Pharmacology Center
Baltimore, Maryland, United States
The pharmacokinetic profile of PT010
The pharmacokinetic profile of PT010 will be assessed at the first day (Day 1) and last dose (Day 8) in each Treatment Period based on: * maximum plasma concentration (Cmax) * area under the plasma concentration-time curve from 0 to 12 hours (AUC0 12) * area under the plasma concentration-time curve from 0 to the time of the last measureable plasma concentration (AUC0-t) * area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC0-∞) (only calculated for Day 1) * time to maximum plasma concentration (tmax) * apparent terminal elimination half-life (t½) * apparent total body clearance (CL/F) * apparent volume of distribution (Vd/F) * terminal elimination rate constant (λz) * accumulation ratio for Cmax (RAC \[Cmax\]) * accumulation ratio for AUC0 12 (RAC \[AUC0 12\]) Other PK parameters may be calculated, as appropriate.
Time frame: 12 hours
Overall safety of PT010
The safety associated with the use of PT010 will be assessed from physical examination findings, adverse event (AE) reporting, vital signs, clinical laboratory values, and findings from 12 lead electrocardiograms (ECGs).
Time frame: 12 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.