Psoriasis
Conditions
Keywords
Moderate to severe chronic plaque-type psoriasis
Brief summary
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.
Detailed description
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.
Interventions
DRUGPlacebo
Dose-matched placebo administered as oral capsule(s) once daily
DRUGVTP-43742
VTP-43742 administered as oral capsule(s) once daily
Sponsors
Vitae Pharmaceuticals Inc., an Allergan affiliate
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy males or females, 18 to 45 years of age, inclusive. * Body weight of at least 55 kg and body mass index of 18-32 kg/m2, inclusive. * Medically healthy with clinically insignificant screening results. * Women of child-bearing potential (WOCBP) AND men with partners who are WOCBP must agree that they and/or their partner will use two reliable forms of contraception as per study requirements * WOCBP must have a negative serum β-hCG pregnancy test at the Screening and Baseline visit. * Voluntarily consent to participate in the trial
Exclusion criteria
* Unwilling or unable to provide written informed consent * History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, coagulation, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease * Evidence of organ dysfunction or any clinically significant deviation from normal in vital signs, physical examination, clinical laboratory determinations or ECG * Any major surgery within 3 months of Screening * Positive urine drug/alcohol testing at Screening or Baseline visit * Use of tobacco and/or nicotine-containing products within 3 months prior to the start of dosing of the trial * Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV Ab) at Screening * History or presence of alcoholism or drug abuse as defined in DSM V, Diagnostic Criteria for Drug and Alcohol Abuse * History of hypersensitivity or idiosyncratic reaction to drugs from multiple drug classes * Any previous gastrointestinal surgery or recent (within 3 months) history of gastrointestinal disease that could impact the absorption of the study drug * Blood donation or significant blood loss within 8 weeks prior to Day 1 of the trial * Plasma donation within 7 days prior to Day 1 of the trial * Blood transfusion within 4 weeks of Screening * Positive serum pregnancy test (WOCBP) at the Screening or Baseline visit * Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical disease (e.g., infectious disease) must not be enrolled into this study * Any other medical, psychiatric, and/or social reason as determined by the Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with treatment-emergent adverse events (TEAEs) in the healthy volunteer (Part 1) group | Study Day 1 to Day 17±2 (follow up) |
Secondary
| Measure | Time frame |
|---|---|
| Maximum plasma concentration (Cmax) in the healthy volunteer (Part 1) group | Day 1 and Day 10 |
| Time to maximum plasma concentrations (tmax) in the healthy volunteer (Part 1) group | 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 | Day 1 and Day 10 |
| Half life (t½) in the healthy volunteer (Part 1) group | Day 10 to Day 13 (72 hours) |
Countries
United States
Outcome results
None listed