This is Part 1 of a two-part, randomized, double-blind, placebo-controlled study in which VTP-43742 was administered to participants; Part 1 in healthy volunteers and Part 2 in psoriatic participants.
This was a prospective, randomized, double-blind, placebo-controlled, ascending multiple dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics effects of VTP-43742 in healthy volunteers conducted at a single, study center in the United States (Part 1). A total of 74 participants were enrolled both parts of the study (Part 1 with 40 healthy subjects; Part 2 with 34 psoriatic participants). This post includes data from Part 1 of the study only; Part 2 is reported separately.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
Healthy Volunteer Site 1
Fair Lawn, New Jersey, United States
Number of participants with treatment-emergent adverse events (TEAEs) in the healthy volunteer (Part 1) group
Time frame: Study Day 1 to Day 17±2 (follow up)
Maximum plasma concentration (Cmax) in the healthy volunteer (Part 1) group
Time frame: Day 1 and Day 10
Time to maximum plasma concentrations (tmax) in the healthy volunteer (Part 1) group
Time frame: Day 1 and Day 10
The area under the plasma concentration versus time curve, from time 0 to the last measurable concentration (AUCt) in the healthy volunteer (Part 1) group
Time frame: Day 1 and Day 10
Half life (t½) in the healthy volunteer (Part 1) group
Time frame: Day 10 to Day 13 (72 hours)
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