Phase I safety and pharmacokinetic trials of 1263W94, a novel oral anti-human cytomegalovirus agent, in healthy and human immunodeficiency virus-infected subjects

Antimicrobial Agents and Chemotherapy

Volumn 47, Issue 4, 2003, Pages 1334-1342

  Wang, Laurene H ^a,c   Peck, Richard W ^b   Yin, Yin ^a   Allanson, Jane ^b   Wiggs, Rebecca ^b   Wire, Mary Beth ^a  

^a GLAXOSMITHKLINE   (United States)

^b GLAXOSMITHKLINE   (United Kingdom)

^c Triangle Pharmaceuticals   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

4469W94; BENZIMIDAVIR; CYTOCHROME P450 3A4; DRUG METABOLITE; UNCLASSIFIED DRUG;

ABDOMINAL PAIN; ADULT; AREA UNDER THE CURVE; ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CYTOMEGALOVIRUS; DEALKYLATION; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DROWSINESS; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG ELIMINATION; DRUG HALF LIFE; DRUG MECHANISM; DRUG POTENCY; DRUG PROTEIN BINDING; DRUG SAFETY; DRUG STRUCTURE; DRUG TOLERABILITY; DRUG URINE LEVEL; ELECTROCARDIOGRAM; FATIGUE; FEVER; FOOD DRUG INTERACTION; HEADACHE; HERPES SIMPLEX; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; IN VITRO STUDY; MALE; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SORE THROAT; STRUCTURE ANALYSIS; TASTE DISORDER; VERTIGO; VIRUS REPLICATION;

ADULT; ANTIVIRAL AGENTS; BENZIMIDAZOLES; CYTOMEGALOVIRUS; DOUBLE-BLIND METHOD; HIV INFECTIONS; HUMANS; MALE; RIBONUCLEOSIDES;

EID: 0037378069     PISSN: 00664804     EISSN: None     Source Type: Journal    
DOI: 10.1128/AAC.47.4.1334-1342.2003     Document Type: Article

References (8)

1. Biron, K. K., R. J. Harvey, S. C. Chamberlain, S. S. Good, A. A. Smith III, M. G. Davis, C. L. Talarico, W. H. Miller, R. Ferris, R. E. Dornsife, S. C. Stanat, J. C. Drach, L. B. Townsend, and G. W. Koszalka. 2002. Potent and selective inhibition of human cytomegalovirus replication by 1263W94, a benzimidazole L-riboside with a unique mode of action. Antimicrob. Agents Chemother. 46:2365-2372.
2. Chan, J., S. Chamberlain, K. Biron, M. Davis, R. Harvey, D. Selleseth, R. Dornsife, E. Dark, L. Frick, L. Townsend, J. Drach, and G. Koszalka. 2000. Synthesis and evaluation of a series of 2′-deoxy analogues of the antiviral agent 5,6-dichloro-2-isopropylamino-2-(β-L-ribofuranosyl)-1H-benzimidazole (1263W94). Nucleosides Nucleotides Nucleic Acids 19:101-123.
3. de la Hoz, R. E., G. Stephens, and C Sherlock. 2002. Diagnosis and treatment approaches to CMV infections in adult patients. J. Clin. Virol. 25:S1-S12.
4. Gaytant, M. A., E. A. Steegers, B. A. Semmekrot, H. M. Merkus, and J. M. Galama. 2002. Congenital cytomegalovirus infection: review of the epidemiology and outcome. Obstet. Gynecol. Surv. 57:245-256.
5. Griffiths, P. 2002. The treatment of cytomegalovirus infection. J. Antimicrob. Chemother. 49:243-253.
6. Koszalka, G. W., N. W. Johnson, S. S. Good, L. Boyd, S. C. Chamberlain, L. B. Townsend, J. C. Drach, and K. K. Biron. 2002. Preclinical and toxicology studies of 1263W94, a potent and selective inhibitor of human cytomegalovirus replication. Antimicrob. Agents Chemother. 46:2373-2380.
7. Lalezari, J., J. Aberg, L. Wang, M. Wire, R. Miner, W. Snowden, C. Talarico, S. Shaw, M. Jacobson, and W. Drew. 2002. A phase I/II dose-escalation trial to evaluate the pharmacokinetics, anti-human cytomegalovirus activity, and safety of 1263W94 in human immunodeficiency virus-infected men with asymptomatic HCMV shedding. Antimicrob. Agents Chemother. 46:2969-2976.
8. van der Bij, W., and R. Speich. 2001. Management of cytomegalovirus infection and disease after solid-organ transplantation Clin. Infect. Dis. 33(Suppl. 1):S32-S37.