Randomized, double-blind, placebo-controlled, multiple-dose study of the safety, tolerability and pharmacokinetics of benvitimod, a candidate drug for the treatment of psoriasis.
What is known and objective Benvitimod is a newly synthesized non-steroidal small molecule, aimed at the treatment for psoriasis. Several trials have demonstrated that benvitimod improves plaque psoriasis. However, its maximum tolerated dose and pharmacokinetic characteristics have not been reported...
| Publicado en: | Journal of Clinical Pharmacy & Therapeutics Vol. 39; no. 4; pp. 418 - 424 |
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| Autores principales: | , , , , , , , , , |
| Formato: | research tables/charts randomized controlled trial Journal Article |
| Publicado: |
Wiley-Blackwell
Aug2014
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=103969949&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 103969949 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 02694727 EV4 jtl: Journal of Clinical Pharmacy & Therapeutics issn: 02694727 maglogo: Y pubinfo: dt: Aug2014 vid: 39 iid: 4 pid: 480 pub: Wiley-Blackwell place: Malden, Massachusetts artinfo: ui: 103969949 96937036 10.1111/jcpt.12158 NLM24673513 103969949 ppf: 418 ppct: 6 formats: fmt: @attributes: type: P tig: atl: Randomized, double-blind, placebo-controlled, multiple-dose study of the safety, tolerability and pharmacokinetics of benvitimod, a candidate drug for the treatment of psoriasis. aug: au: Zhao, L. Chen, X. Cai, L. Zhang, C. Wang, Q. Jing, S. Chen, G. Li, J. Zhang, J. Fang, Y. affil: Phase I Research Unit, Department of Pharmacy, Peking University People's Hospital sug: subj: Psoriasis Drug Therapy Antiinflammatory Agents, Non-Steroidal Pharmacokinetics Drug Tolerance Patient Safety Human Randomized Controlled Trials Double-Blind Studies Placebos China Administration, Topical Descriptive Statistics Chromatography, High Pressure Liquid Antiinflammatory Agents, Non-Steroidal Administration and Dosage Molecular Structure Academic Medical Centers Female Male Adolescence Young Adult Adult Middle Age Questionnaires Blood Chemical Analysis Data Analysis Software T-Tests Analysis of Variance Antiinflammatory Agents, Non-Steroidal Adverse Effects Funding Source Adolescent: 13-18 years Adult: 19-44 years Middle Aged: 45-64 years Female Male ab: What is known and objective Benvitimod is a newly synthesized non-steroidal small molecule, aimed at the treatment for psoriasis. Several trials have demonstrated that benvitimod improves plaque psoriasis. However, its maximum tolerated dose and pharmacokinetic characteristics have not been reported on. The goals of this study were to evaluate the safety, tolerability and pharmacokinetics of benvitimod after topical administration in healthy subjects. Methods This phase I trial in healthy subjects was designed as a randomized, double-blind, placebo-controlled, ascending-dose study. After screening and randomization, 56 volunteers received benvitimod (0·5-2·0%) or placebo cream once or twice daily. Doses were escalated from 5 to 30 mg daily in six cohorts. Safety and tolerability were appraised by monitoring adverse events and laboratory parameters. Benvitimod concentrations were measured using liquid chromatography-tandem-mass spectrometry. Results and discussion Exposure to benvitimod did not result in electrocardiographic or clinical laboratory changes. Doses up to 30 mg were well tolerated. All adverse events were mild. Adverse effects at the application site were observed in subjects randomized to benvitimod 5 mg q.d and b.i.d, but there were no observable dose effects in the dose-range evaluated. Benvitimod was detected in fewer than 5% of the plasma samples. What is new and Conclusions Benvitimod cream, at single doses of up to 30 mg, is well tolerated by healthy subjects. Following topical application, systemic absorption was negligible. pubtype: Academic Journal doctype: research tables/charts randomized controlled trial Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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