An Ascending Multiple Dose Study With VTP-43742 in Healthy Volunteers and Psoriatic Patients
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
1 other identifier
interventional
74
1 country
14
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2015
Shorter than P25 for phase_1
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 15, 2015
CompletedFirst Posted
Study publicly available on registry
September 21, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedOctober 30, 2018
October 1, 2018
7 months
September 15, 2015
October 26, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
safety data, including AEs, laboratory evaluations, ECG results, and vital signs assessments, will be listed by subject and summarized by dose and time point
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
28 days
Secondary Outcomes (6)
Maximum plasma concentration (Cmax) will be summarized using descriptive statistics by visit and dose level
Day 1, 10 and 28
Time to maximum plasma concentrations (tmax) will be summarized using descriptive statistics by visit and dose level
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
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
Day 1, 10 and 28
Half life (t½) will be summarized using descriptive statistics by visit and dose level
Day 1, 10 and 28
- +1 more secondary outcomes
Other Outcomes (1)
changes from baseline and/or placebo for IL-17 plasma levels
Day 1, 10 and 28
Study Arms (13)
Placebo 1
PLACEBO COMPARATORhealthy volunteers
VTP-43742 Dose 1
EXPERIMENTALhealthy volunteers
VTP-43742 Dose 2
EXPERIMENTALhealthy volunteers
VTP-43742 Dose 3
EXPERIMENTALhealthy volunteers
VTP-43742 Dose 4
EXPERIMENTALhealthy volunteers
VTP-43742 Dose 5
EXPERIMENTALhealthy volunteers
VTP-43742 Dose 6
EXPERIMENTALhealthy volunteers
VTP-43742 Dose 7
EXPERIMENTALhealthy volunteers
Placebo 2
PLACEBO COMPARATORpsoriatic patients
VTP-43742 Dose 8
EXPERIMENTALpsoriatic patients
VTP-43742 Dose 9
EXPERIMENTALpsoriatic patients
VTP-43742 Dose 10
EXPERIMENTALpsoriatic patients
VTP-43742 Dose 11
EXPERIMENTALpsoriatic patients
Interventions
VTP-43742 administered as an oral capsule once daily
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Patient Site 5
Rogers, Arkansas, 72758, United States
Patient Site 1
Miami, Florida, 33144, United States
Patient Site 8
Tampa, Florida, 33609, United States
Patient 12
Tampa, Florida, 33624, United States
Patient Site 13
Carmel, Indiana, 46032, United States
Patient Site 4
Plainfield, Indiana, 46168, United States
Healthy Volunteer Site 1
Fair Lawn, New Jersey, 07410, United States
Patient Site 2
New York, New York, 10012, United States
Patient Site 9
High Point, North Carolina, 27265, United States
Patient Site 6
College Station, Texas, 77845, United States
Patient Site 3
Dallas, Texas, 75231, United States
Patient Site 10
Houston, Texas, 77004, United States
Patient Site 11
Houston, Texas, 77065, United States
Patient Site 7
Webster, Texas, 77598, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Richard Gregg, MD
Vitae Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2015
First Posted
September 21, 2015
Study Start
August 1, 2015
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
October 30, 2018
Record last verified: 2018-10