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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 )

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.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Placebo Drug: VTP-43742 Phase 1

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  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 1, 2015
Actual Primary Completion Date : March 8, 2016
Actual Study Completion Date : March 8, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

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




Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. Maximum plasma concentration (Cmax) in the healthy volunteer (Part 1) group [ Time Frame: Day 1 and Day 10 ]
  2. Time to maximum plasma concentrations (tmax) in the healthy volunteer (Part 1) group [ Time Frame: Day 1 and Day 10 ]
  3. 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 ]
  4. Half life (t½) in the healthy volunteer (Part 1) group [ Time Frame: Day 10 to Day 13 (72 hours) ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03724292


Locations
United States, New Jersey
Healthy Volunteer Site 1
Fair Lawn, New Jersey, United States, 07410
Sponsors and Collaborators
Vitae Pharmaceuticals Inc., an Allergan affiliate
Investigators
Study Director: Richard Gregg, MD Vitae Pharmaceuticals

Responsible Party: Vitae Pharmaceuticals Inc., an Allergan affiliate
ClinicalTrials.gov Identifier: NCT03724292     History of Changes
Other Study ID Numbers: VTP-43742-002-1
First Posted: October 30, 2018    Key Record Dates
Last Update Posted: October 30, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Vitae Pharmaceuticals, Inc. ( Vitae Pharmaceuticals Inc., an Allergan affiliate ):
Moderate to severe chronic plaque-type psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases