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

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03724292
• Other study ID #: VTP-43742-002-1
• Status: Completed
• Phase: Phase 1
• Start date: August 1, 2015
• Est. completion date: March 8, 2016

Study information

• Verified date: October 2018
• Source: Vitae Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 8, 2016
• Est. primary completion date: March 8, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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 ß-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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Placebo
Dose-matched placebo administered as oral capsule(s) once daily
• VTP-43742
VTP-43742 administered as oral capsule(s) once daily

Locations

Country	Name	City	State
United States	Healthy Volunteer Site 1	Fair Lawn	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Vitae Pharmaceuticals Inc., an Allergan affiliate

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Maximum plasma concentration (Cmax) in the healthy volunteer (Part 1) group		Day 1 and Day 10
Secondary	Time to maximum plasma concentrations (tmax) in the healthy volunteer (Part 1) group		Day 1 and Day 10
Secondary	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
Secondary	Half life (t½) in the healthy volunteer (Part 1) group		Day 10 to Day 13 (72 hours)