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

Vitae Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Psoriasis

Treatments

Drug: VTP-43742

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03724292

VTP-43742-002-1

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Quadruple Blind

40 participants in 6 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

VTP-43742 Dose 1

Experimental group

Description: