An Ascending Multiple Dose Study With VTP-43742 in Healthy Volunteers

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Double-blind, Placebo-controlled, Ascending Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VTP-43742 in Healthy Volunteers and Proof-of-Concept in Psoriatic Patients

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: Placebo
* Drug: VTP-43742


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Dose-matched placebo administered as oral capsule(s) once daily | Drug: Placebo<br>* Dose-matched placebo administered as oral capsule(s) once daily<br>|
| Experimental: VTP-43742 Dose 1<br>VTP-43742 administered as oral capsule(s) once daily | Drug: VTP-43742<br>* VTP-43742 administered as oral capsule(s) once daily<br>|
| Experimental: VTP-43742 Dose 2<br>VTP-43742 administered as oral capsule(s) once daily | Drug: VTP-43742<br>* VTP-43742 administered as oral capsule(s) once daily<br>|
| Experimental: VTP-43742 Dose 3<br>VTP-43742 administered as oral capsule(s) once daily | Drug: VTP-43742<br>* VTP-43742 administered as oral capsule(s) once daily<br>|
| Experimental: VTP-43742 Dose 4<br>VTP-43742 administered as oral capsule(s) once daily | Drug: VTP-43742<br>* VTP-43742 administered as oral capsule(s) once daily<br>|
| Experimental: VTP-43742 Dose 5<br>VTP-43742 administered as oral capsule(s) once daily | Drug: VTP-43742<br>* VTP-43742 administered as oral capsule(s) once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Moderate to severe chronic plaque-type psoriasis