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

Primary Purpose

Psoriasis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Placebo

VTP-43742

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Moderate to severe chronic plaque-type psoriasis

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Healthy Volunteer Site 1

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

VTP-43742 Dose 1

VTP-43742 Dose 2

VTP-43742 Dose 3

VTP-43742 Dose 4

VTP-43742 Dose 5

Arm Description

Dose-matched placebo administered as oral capsule(s) once daily

VTP-43742 administered as oral capsule(s) once daily

Outcomes

Primary Outcome Measures

Number of participants with treatment-emergent adverse events (TEAEs) in the healthy volunteer (Part 1) group

Secondary Outcome Measures

Maximum plasma concentration (Cmax) in the healthy volunteer (Part 1) group

Time to maximum plasma concentrations (tmax) in the healthy volunteer (Part 1) group

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

Half life (t½) in the healthy volunteer (Part 1) group

Full Information

NCT ID

NCT03724292

First Posted

October 26, 2018

Last Updated

October 26, 2018

Sponsor

Vitae Pharmaceuticals Inc., an Allergan affiliate

1. Study Identification

Unique Protocol Identification Number

NCT03724292

Brief Title

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

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

August 1, 2015 (Actual)

Primary Completion Date

March 8, 2016 (Actual)

Study Completion Date

March 8, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Vitae Pharmaceuticals Inc., an Allergan affiliate

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis

Keywords

Moderate to severe chronic plaque-type psoriasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Factorial Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Dose-matched placebo administered as oral capsule(s) once daily

Arm Title

VTP-43742 Dose 1

Arm Type

Experimental

Arm Description

VTP-43742 administered as oral capsule(s) once daily

Arm Title

VTP-43742 Dose 2

Arm Type

Experimental

Arm Description

VTP-43742 administered as oral capsule(s) once daily

Arm Title

VTP-43742 Dose 3

Arm Type

Experimental

Arm Description

VTP-43742 administered as oral capsule(s) once daily

Arm Title

VTP-43742 Dose 4

Arm Type

Experimental

Arm Description

VTP-43742 administered as oral capsule(s) once daily

Arm Title

VTP-43742 Dose 5

Arm Type

Experimental

Arm Description

VTP-43742 administered as oral capsule(s) once daily

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Dose-matched placebo administered as oral capsule(s) once daily

Intervention Type

Drug

Intervention Name(s)

VTP-43742

Intervention Description

VTP-43742 administered as oral capsule(s) once daily

Primary Outcome Measure Information:

Title

Number of participants with treatment-emergent adverse events (TEAEs) in the healthy volunteer (Part 1) group

Time Frame

Study Day 1 to Day 17±2 (follow up)

Secondary Outcome Measure Information:

Title

Maximum plasma concentration (Cmax) in the healthy volunteer (Part 1) group

Time Frame

Day 1 and Day 10

Title

Time to maximum plasma concentrations (tmax) in the healthy volunteer (Part 1) group

Time Frame

Day 1 and Day 10

Title

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

Time Frame

Day 1 and Day 10

Title

Half life (t½) in the healthy volunteer (Part 1) group

Time Frame

Day 10 to Day 13 (72 hours)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard Gregg, MD

Organizational Affiliation

Vitae Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Healthy Volunteer Site 1

City

Fair Lawn

State/Province

New Jersey

ZIP/Postal Code

07410

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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