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Trial record 1 of 1 for:    VTP-43742
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An Ascending Multiple Dose Study With VTP-43742 in Healthy Volunteers and Psoriatic Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vitae Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT02555709
First received: September 15, 2015
Last updated: December 22, 2016
Last verified: December 2016
  Purpose
This is a two-part, randomized, double-blind, placebo-controlled study in which VTP-43742 will be administered to normal healthy volunteers (NHV) and to moderate to severe psoriatic patients, both in sequential ascending dose panels.

Condition Intervention Phase
Psoriasis
Drug: VTP-43742
Drug: Placebo 1
Drug: Placebo 2
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
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 Psoriatic Patients and Clinical Proof-of-Concept in Psoriatic Patients

Further study details as provided by Vitae Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • safety data, including AEs, laboratory evaluations, ECG results, and vital signs assessments, will be listed by subject and summarized by dose and time point [ Time Frame: 10 days ]
  • safety data, including AEs, laboratory evaluations, ECG results, and vital signs assessments, will be listed by subject and summarized by dose and time point [ Time Frame: 28 days ]

Secondary Outcome Measures:
  • Maximum plasma concentration (Cmax) will be summarized using descriptive statistics by visit and dose level [ Time Frame: Day 1, 10 and 28 ]
  • Time to maximum plasma concentrations (tmax) will be summarized using descriptive statistics by visit and dose level [ Time Frame: Day 1, 10 and 28 ]
  • The area under the plasma concentration versus time curve, from time 0 to the last measurable concentration (AUCt) will be summarized using descriptive statistics by visit and dose level [ Time Frame: Day 1, 10 and 28 ]
  • The area under the plasma concentration versus time curve, from time 0 to infinity (by extrapolation) (AUC∞) will be summarized using descriptive statistics by visit and dose level [ Time Frame: Day 1, 10 and 28 ]
  • Half life (t½) will be summarized using descriptive statistics by visit and dose level [ Time Frame: Day 1, 10 and 28 ]
  • Percent change from baseline in total PASI will be summarized using descriptive statistics by visit and dose level [ Time Frame: 28 days ]

Other Outcome Measures:
  • changes from baseline and/or placebo for IL-17 plasma levels [ Time Frame: Day 1, 10 and 28 ]

Enrollment: 74
Study Start Date: August 2015
Study Completion Date: March 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo 1
healthy volunteers
Drug: Placebo 1
Placebo 1 matching VTP-43742 administered as an oral capsule once daily
Experimental: VTP-43742 Dose 1
healthy volunteers
Drug: VTP-43742
VTP-43742 administered as an oral capsule once daily
Experimental: VTP-43742 Dose 2
healthy volunteers
Drug: VTP-43742
VTP-43742 administered as an oral capsule once daily
Experimental: VTP-43742 Dose 3
healthy volunteers
Drug: VTP-43742
VTP-43742 administered as an oral capsule once daily
Experimental: VTP-43742 Dose 4
healthy volunteers
Drug: VTP-43742
VTP-43742 administered as an oral capsule once daily
Experimental: VTP-43742 Dose 5
healthy volunteers
Drug: VTP-43742
VTP-43742 administered as an oral capsule once daily
Experimental: VTP-43742 Dose 6
healthy volunteers
Drug: VTP-43742
VTP-43742 administered as an oral capsule once daily
Experimental: VTP-43742 Dose 7
healthy volunteers
Drug: VTP-43742
VTP-43742 administered as an oral capsule once daily
Placebo Comparator: Placebo 2
psoriatic patients
Drug: Placebo 2
Placebo 2 matching VTP-43742 administered as an oral capsule once daily
Experimental: VTP-43742 Dose 8
psoriatic patients
Drug: VTP-43742
VTP-43742 administered as an oral capsule once daily
Experimental: VTP-43742 Dose 9
psoriatic patients
Drug: VTP-43742
VTP-43742 administered as an oral capsule once daily
Experimental: VTP-43742 Dose 10
psoriatic patients
Drug: VTP-43742
VTP-43742 administered as an oral capsule once daily
Experimental: VTP-43742 Dose 11
psoriatic patients
Drug: VTP-43742
VTP-43742 administered as an oral capsule once daily

Detailed Description:
This is 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 and in patients with moderate to severe chronic plaque-type psoriasis at approximately 8 study centers in the United States. A total of 108 participants will be enrolled in the study (48 healthy subjects and 60 psoriatic patients).
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Healthy Volunteer 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) may be enrolled if they agree to use two of the reliable forms of contraception
  • Men with partners who are WOCBP must agree that they and/or their partner will use two of the reliable forms of contraception
  • WOCBP must have a negative serum βhCG pregnancy test at the Check-in visit.
  • Voluntarily consent to participate in the trial

Psoriasis Patient Inclusion Criteria:

  • Confirmed diagnosis of chronic plaque-type psoriasis, diagnosed at least 6 months before study with at least moderate severity, which is defined as PASI≥10, PGA≥3, and % BSA≥8
  • Otherwise medically healthy and with otherwise clinically insignificant screening laboratory test results
  • Males or females, 18 to 75 years of age, inclusive
  • Body weight of at least 55 kg and body mass index of 18-35 kg/m2, inclusive.
  • WOCBP may be enrolled if they agree to use two of the reliable forms of contraception
  • Men with partners who are WOCBP must agree that they and/or their partner will use two of the reliable forms of contraception
  • WOCBP must have a negative serum β hCG pregnancy test at the Screening and Baseline visit
  • Voluntarily consent to participate in the trial

Healthy Volunteer 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 1of 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

Psoriatic Patient Exclusion Criteria:

  • Unwilling or unable to provide written informed consent
  • Efficacy failure on two or more biological agents for the treatment of psoriasis when the failures occurred within one year of the initiation of the therapy of the first biological agent
  • Current treatment or history of treatment for psoriasis with biologicals within 6 months of study Day 1
  • Current treatment or history of treatment for psoriasis with non-biological systemic medications within 4 weeks of Day 1 and treatment with topical agents within 2 weeks of Day 1
  • 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 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 IV, 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 positive urine pregnancy test with confirmatory serum pregnancy test on Day 1
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02555709

Locations
United States, Arkansas
Patient Site 5
Rogers, Arkansas, United States, 72758
United States, Florida
Patient Site 1
Miami, Florida, United States, 33144
Patient Site 8
Tampa, Florida, United States, 33609
Patient 12
Tampa, Florida, United States, 33624
United States, Indiana
Patient Site 13
Carmel, Indiana, United States, 46032
Patient Site 4
Plainfield, Indiana, United States, 46168
United States, New Jersey
Healthy Volunteer Site 1
Fair Lawn, New Jersey, United States, 07410
United States, New York
Patient Site 2
New York, New York, United States, 10012
United States, North Carolina
Patient Site 9
High Point, North Carolina, United States, 27265
United States, Texas
Patient Site 6
College Station, Texas, United States, 77845
Patient Site 3
Dallas, Texas, United States, 75231
Patient Site 10
Houston, Texas, United States, 77004
Patient Site 11
Houston, Texas, United States, 77065
Patient Site 7
Webster, Texas, United States, 77598
Sponsors and Collaborators
Vitae Pharmaceuticals, Inc.
Investigators
Study Director: Richard Gregg, MD Vitae Pharmaceuticals
  More Information

Responsible Party: Vitae Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02555709     History of Changes
Other Study ID Numbers: VTP-43742-002
Study First Received: September 15, 2015
Last Updated: December 22, 2016

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

ClinicalTrials.gov processed this record on April 26, 2017