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

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ClinicalTrials.gov Identifier: NCT03724292
Recruitment Status : Completed
First Posted : October 30, 2018
Last Update Posted : October 30, 2018
Sponsor:
Information provided by (Responsible Party):
Vitae Pharmaceuticals, Inc. ( Vitae Pharmaceuticals Inc., an Allergan affiliate )

Tracking Information
First Submitted Date  ICMJE October 26, 2018
First Posted Date  ICMJE October 30, 2018
Last Update Posted Date October 30, 2018
Actual Study Start Date  ICMJE August 1, 2015
Actual Primary Completion Date March 8, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 26, 2018)
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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2018)
  • 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) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Ascending Multiple Dose Study With VTP-43742 in Healthy Volunteers
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE
  • Drug: Placebo
    Dose-matched placebo administered as oral capsule(s) once daily
  • Drug: VTP-43742
    VTP-43742 administered as oral capsule(s) once daily
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Dose-matched placebo administered as oral capsule(s) once daily
    Intervention: Drug: Placebo
  • Experimental: VTP-43742 Dose 1
    VTP-43742 administered as oral capsule(s) once daily
    Intervention: Drug: VTP-43742
  • Experimental: VTP-43742 Dose 2
    VTP-43742 administered as oral capsule(s) once daily
    Intervention: Drug: VTP-43742
  • Experimental: VTP-43742 Dose 3
    VTP-43742 administered as oral capsule(s) once daily
    Intervention: Drug: VTP-43742
  • Experimental: VTP-43742 Dose 4
    VTP-43742 administered as oral capsule(s) once daily
    Intervention: Drug: VTP-43742
  • Experimental: VTP-43742 Dose 5
    VTP-43742 administered as oral capsule(s) once daily
    Intervention: Drug: VTP-43742
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 26, 2018)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 8, 2016
Actual Primary Completion Date March 8, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03724292
Other Study ID Numbers  ICMJE VTP-43742-002-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vitae Pharmaceuticals, Inc. ( Vitae Pharmaceuticals Inc., an Allergan affiliate )
Study Sponsor  ICMJE Vitae Pharmaceuticals Inc., an Allergan affiliate
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Richard Gregg, MD Vitae Pharmaceuticals
PRS Account Vitae Pharmaceuticals, Inc.
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP