This is a two-part, randomized, double-blind, placebo-controlled study in which VTP-43742 will be administered to normal healthy volunteers (NHV) and to moderate to severe psoriatic patients, both in sequential ascending dose panels.
This is 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 and in patients with moderate to severe chronic plaque-type psoriasis at approximately 8 study centers in the United States. A total of 108 participants will be enrolled in the study (48 healthy subjects and 60 psoriatic patients).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
74
Patient Site 5
Rogers, Arkansas, United States
Patient Site 1
Miami, Florida, United States
Patient Site 8
Tampa, Florida, United States
safety data, including AEs, laboratory evaluations, ECG results, and vital signs assessments, will be listed by subject and summarized by dose and time point
Time frame: 10 days
safety data, including AEs, laboratory evaluations, ECG results, and vital signs assessments, will be listed by subject and summarized by dose and time point
Time frame: 28 days
Maximum plasma concentration (Cmax) will be summarized using descriptive statistics by visit and dose level
Time frame: Day 1, 10 and 28
Time to maximum plasma concentrations (tmax) will be summarized using descriptive statistics by visit and dose level
Time frame: Day 1, 10 and 28
The area under the plasma concentration versus time curve, from time 0 to the last measurable concentration (AUCt) will be summarized using descriptive statistics by visit and dose level
Time frame: Day 1, 10 and 28
The area under the plasma concentration versus time curve, from time 0 to infinity (by extrapolation) (AUC∞) will be summarized using descriptive statistics by visit and dose level
Time frame: Day 1, 10 and 28
Half life (t½) will be summarized using descriptive statistics by visit and dose level
Time frame: Day 1, 10 and 28
Percent change from baseline in total PASI will be summarized using descriptive statistics by visit and dose level
Time frame: 28 days
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Patient 12
Tampa, Florida, United States
Patient Site 13
Carmel, Indiana, United States
Patient Site 4
Plainfield, Indiana, United States
Healthy Volunteer Site 1
Fair Lawn, New Jersey, United States
Patient Site 2
New York, New York, United States
Patient Site 9
High Point, North Carolina, United States
Patient Site 6
College Station, Texas, United States
...and 4 more locations