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

NCT03724292 | Completed Phase 1 FDA Drug

• 1 other identifier: VTP-43742-002-1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Keywords

Moderate to severe chronic plaque-type psoriasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• 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

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

  Day 10 to Day 13 (72 hours)

Study Arms (6)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

VTP-43742 Dose 1

EXPERIMENTAL

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

Drug: VTP-43742

VTP-43742 Dose 2

EXPERIMENTAL

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

Drug: VTP-43742

VTP-43742 Dose 3

EXPERIMENTAL

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

Drug: VTP-43742

VTP-43742 Dose 4

EXPERIMENTAL

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

Drug: VTP-43742

VTP-43742 Dose 5

EXPERIMENTAL

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

Drug: VTP-43742

Interventions

Placebo DRUG

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

Placebo

VTP-43742 DRUG

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

VTP-43742 Dose 1; VTP-43742 Dose 2; VTP-43742 Dose 3; VTP-43742 Dose 4; VTP-43742 Dose 5

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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) 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

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 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

Sponsors & Collaborators

• Vitae Pharmaceuticals Inc., an Allergan affiliate: lead

Study Sites (1)

Healthy Volunteer Site 1

Fair Lawn, New Jersey, 07410, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

VTP-43742

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Richard Gregg, MD

  Vitae Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2018
• First Posted: October 30, 2018
• Study Start: August 1, 2015
• Primary Completion: March 8, 2016
• Study Completion: March 8, 2016
• Last Updated: October 30, 2018

Record last verified: 2018-10

Locations

US (1)