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

Completed · Phase 1 · Has a placebo group

Conditions studied: Psoriasis

In brief

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.

Key facts

Study ID

NCT03724292

Run by

Vitae Pharmaceuticals Inc., an Allergan affiliate

People needed

40

Starts

2015-08-01

Expected to finish

2016-03-08

Last updated by the study team

2018-10-30

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

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
• Any other medical, psychiatric, and/or social reason as determined by the Investigator

Where it is running

• Healthy Volunteer Site 1 — Fair Lawn, New Jersey, United States

Full record on ClinicalTrials.gov

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