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

Phase 1

Completed

• Conditions: Psoriasis
• Interventions: Drug: VTP-43742; Drug: Placebo

• Registration Number: NCT03724292
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-08-01
• Primary Completion: 2016-03-08
• Study Completion: 2016-03-08
• Status Verified: 2018-10
• Study First Submitted: 2018-10-26
• Study First Submitted QC: 2018-10-26
• Last Update Submitted: 2018-10-26
• Study First Posted: 2018-10-30
• Last Update Posted: 2018-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
VTP-43742 Dose 5	VTP-43742	VTP-43742 administered as oral capsule(s) once daily
Placebo	Placebo	Dose-matched placebo administered as oral capsule(s) once daily
VTP-43742 Dose 1	VTP-43742	VTP-43742 administered as oral capsule(s) once daily
VTP-43742 Dose 2	VTP-43742	VTP-43742 administered as oral capsule(s) once daily
VTP-43742 Dose 3	VTP-43742	VTP-43742 administered as oral capsule(s) once daily
VTP-43742 Dose 4	VTP-43742	VTP-43742 administered as oral capsule(s) once daily

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment-emergent adverse events (TEAEs) in the healthy volunteer (Part 1) group	Study Day 1 to Day 17±2 (follow up)

Secondary Outcome Measures

Name	Time	Method
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	Day 1 and Day 10
Maximum plasma concentration (Cmax) in the healthy volunteer (Part 1) group	Day 1 and Day 10
Time to maximum plasma concentrations (tmax) in the healthy volunteer (Part 1) group	Day 1 and Day 10
Half life (t½) in the healthy volunteer (Part 1) group	Day 10 to Day 13 (72 hours)

Trial Locations

Locations (1)

Healthy Volunteer Site 1; 🇺🇸 Fair Lawn, New Jersey, United States