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

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

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Placebo; Drug: VTP-43742

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Fair Lawn, New Jersey, United States, 07410
      • Healthy Volunteer Site 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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)

Collaborators and Investigators

• Sponsor: Vitae Pharmaceuticals Inc., an Allergan affiliate
• Investigators: Study Director: Richard Gregg, MD, Vitae Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): March 8, 2016
• Study Completion (Actual): March 8, 2016

Study Registration Dates

• First Submitted: October 26, 2018
• First Submitted That Met QC Criteria: October 26, 2018
• First Posted (Actual): October 30, 2018

Study Record Updates

• Last Update Posted (Actual): October 30, 2018
• Last Update Submitted That Met QC Criteria: October 26, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Moderate to severe chronic plaque-type psoriasis
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: VTP-43742-002-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No