Clinical trial NCT03724292: An Ascending Multiple Dose Study With VTP-43742 in Healthy Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psoriasis
Keywords: Moderate to severe chronic plaque-type psoriasis
Lead sponsor: Vitae Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2018-10-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Number of participants with treatment-emergent adverse events (TEAEs) in the healthy volunteer (Part 1) group
timeFrame: Study Day 1 to Day 17±2 (follow up)
Secondary outcomes:
measure: Maximum plasma concentration (Cmax) in the healthy volunteer (Part 1) group
timeFrame: Day 1 and Day 10
measure: Time to maximum plasma concentrations (tmax) in the healthy volunteer (Part 1) group
timeFrame: Day 1 and Day 10
measure: 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
timeFrame: Day 1 and Day 10
measure: Half life (t½) in the healthy volunteer (Part 1) group
timeFrame: Day 10 to Day 13 (72 hours)
Other outcomes:
Locations:
city: Fair Lawn
country: United States
facility: Healthy Volunteer Site 1
state: New Jersey
Study officials:
affiliation: Vitae Pharmaceuticals
name: Richard Gregg, MD
role: STUDY_DIRECTOR
References: