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Titolo:
Pharmacokinetics and tolerability of intravenous Trecovirsen (GEM (R) 91),an antisense phosphorothioate oligonucleotide, in HIV-positive subjects
Autore:
Sereni, D; Tubiana, R; Lascoux, C; Katlama, C; Taulera, O; Bourque, A; Cohen, A; Dvorchik, B; Martin, RR; Tournerie, C; Gouyette, A; Schechter, PJ;
Indirizzi:
Hop Cochin, Serv Med Interne, F-75674 Paris, France Hop Cochin Paris France F-75674 Serv Med Interne, F-75674 Paris, France Hop La Pitie Salpetriere, Serv Malad Infect & Trop, Paris, France Hop La Pitie Salpetriere Paris France alad Infect & Trop, Paris, France Hybridon Inc, Cambridge, MA USA Hybridon Inc Cambridge MA USAHybridon Inc, Cambridge, MA USA InsteGustave Roussy, Dept Pharmacotoxicol & Pharmacogenet, Villejuif, Franc Inst Gustave Roussy Villejuif France & Pharmacogenet, Villejuif, Franc
Titolo Testata:
JOURNAL OF CLINICAL PHARMACOLOGY
fascicolo: 1, volume: 39, anno: 1999,
pagine: 47 - 54
SICI:
0091-2700(199901)39:1<47:PATOIT>2.0.ZU;2-K
Fonte:
ISI
Lingua:
ENG
Soggetto:
ANION-EXCHANGE CHROMATOGRAPHY; IMMUNODEFICIENCY-VIRUS TYPE-1; PHASE-I TRIAL; OLIGODEOXYNUCLEOTIDE PHOSPHOROTHIOATES; QUANTITATIVE-ANALYSIS; THERAPEUTIC AGENT; BIODISTRIBUTION; COMPLEMENTARY; GEM-91; MICE;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Life Sciences
Citazioni:
19
Recensione:
Indirizzi per estratti:
Indirizzo: Martin, RR Hybridon Inc, 155 Fortune Blvd, Milford, MA 01757 USA Hybridon Inc 155 Fortune Blvd Milford MA USA 01757 MA 01757 USA
Citazione:
D. Sereni et al., "Pharmacokinetics and tolerability of intravenous Trecovirsen (GEM (R) 91),an antisense phosphorothioate oligonucleotide, in HIV-positive subjects", J CLIN PHAR, 39(1), 1999, pp. 47-54

Abstract

Trecovirsen, a 25-mer antisense phosphorothioate oligonucleotide targeted at the gag site of the HIV gene, was administered to HN-positive volunteersas an IV infusion. Single doses ranged from 0.1 to 2.5 mg/kg in an ascending escalation in cohorts of 6 to 22 subjects. Plasma trecovirsen concentrations and pharmacokinetic parameters could be assessed at doses greater thanor equal to 0.3 mg/kg. Peak plasma concentrations and AUC values increaseddisproportionately with increasing dose while elimination half-life increased and plasma clearance decreased, indicating a saturable process over this dose range. The only significant adverse event observed was an isolated, transitory increase in activated partial thromboplastin time at doses greater than or equal to 2.0 mg/kg that was related to plasma trecovirsen concentrations and is attributed to the polyanionic character of the molecule. Thus, trecovirsen administration was well tolerated in single IV doses up to 2.5 mg/kg Journal of Clinical Pharmacology, 1999;39:47-54 (C) 1999 the American College of Clinical Pharmacology.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 25/11/20 alle ore 04:49:32