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

• Status: Completed
• Trial end date: 2016-03-08
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Vitae Pharmaceuticals Inc., an Allergan affiliate

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