This is single center, randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of BPN-14967 in healthy adult subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
40
PPD Phase I Clinic
Austin, Texas, United States
Area under the plasma concentration versus time curve from time 0 to the last timepoint with quantifiable concentration [AUC(0-t)]
Time frame: Up to Day 8
Area under the plasma concentration versus time curve from time 0 extrapolated to infinity [AUC(0-inf)]
Time frame: Up to Day 8
Maximum observed plasma concentration (Cmax)
Time frame: Up to Day 8
Time to maximum observed plasma concentration (Tmax)
Time frame: Up to Day 8
Terminal elimination rate constant
Time frame: Up to Day 8
Terminal phase half-life (t1/2)
Time frame: Up to Day 8
Apparent total body clearance (CL/F)
Time frame: Up to Day 8
Apparent volume of distribution (Vz/F)
Time frame: Up to Day 8
Number of participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs leading to discontinuation
Time frame: Up to Day 10
Number of participants with Clinical Laboratory Results Abnormalities
Time frame: Up to Day 10
Number of participants with Vital Sign Abnormalities
Time frame: Up to Day 10
Number of participants with Physical Examination Abnormalities
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Time frame: Up to Day 10
Number of participants with 12-lead Electrocardiogram (ECG) Abnormalities
Time frame: Up to Day 10
Number of participants with changes in visual acuity
Time frame: Baseline and Day 10
Number of participants with Ocular Examination Abnormalities
Time frame: Up to Day 10
Number of participants with changes in color vision
Time frame: Baseline and Day 10