an ascending multiple dose study with vtp-43742 in healthy volunteers

Conditions: Psoriasis

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.

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.

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

Keywords: moderate to severe chronic plaque-type psoriasis