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Antimicrobial Agents and Chemotherapy, June 2000, p. 1667-1673, Vol. 44, No. 6
0066-4804/00/$04.00+0
Copyright © 2000, American Society for Microbiology. All rights reserved.

Pharmacokinetics and Safety of AMD-3100, a Novel Antagonist of the CXCR-4 Chemokine Receptor, in Human Volunteers

Craig W. Hendrix,1,* Charles Flexner,1 Ronald T. MacFarland,2 Christen Giandomenico,2 Edward J. Fuchs,1 Ella Redpath,1 Gary Bridger,2 and Geoffrey W. Henson2

Division of Clinical Pharmacology, Johns Hopkins University School of Medicine, Baltimore, Maryland 21287,1 and AnorMED, Inc., Langley, British Columbia, Canada V2Y 1N52

Received 9 August 1999/Returned for modification 15 January 2000/Accepted 18 March 2000

AMD-3100, a bicyclam, is a novel agent that uniquely inhibits the entry of human immunodeficiency virus type 1 (HIV-1) into CD4+ T cells via selective blockade of the chemokine CXCR-4 receptor. Twelve healthy volunteers were given AMD-3100 as a single 15-min intravenous infusion at 10, 20, 40, or 80 µg/kg. Five subjects also received a single subcutaneous injection of AMD-3100 (40 or 80 µg/kg). Three subjects received two escalating oral doses each (80 and 160 µg/kg). All subjects tolerated their dose(s) well without any grade 2 toxicity or dose adjustment. Six subjects experienced mild, transient symptoms, primarily gastrointestinal in nature and not dose related. All subjects experienced a dose-related elevation of the white blood cell count, from 1.5 to 3.1 times the baseline, which returned to the baseline 24 h after dosing. AMD-3100 demonstrated dose proportionality for the maximum drug concentration in serum (Cmax) and the area under the concentration-time curve from 0 h to infinity  (AUC0-infinity ) over the entire dose range. At the highest intravenous dose (80 µg/kg), the median Cmax was 515 (range, 470 to 521) ng/ml and the AUC0-infinity was 1,044 (range, 980 to 1,403) ng-h/ml. The median systemic absorption after subcutaneous dosing was 87% (range, 67 to 106%). No drug was detectable in the blood following oral dosing. Using a two-compartment model, the median pharmacokinetic parameter estimates (ranges) were as follows: volume of distribution, 0.34 (0.27 to 0.36) liter/kg; clearance, 1.30 (0.97 to 1.34) liters/h; elimination half-life, 3.6 (3.5 to 4.9) h. After a single, well-tolerated intravenous dose of AMD-3100, concentrations were sustained for 12 h above the in vitro antiretroviral 90% inhibitory concentrations and for 8 h above antiviral concentrations identified in the SCID-hu Thy/Liv mouse model of HIV infection.

* Corresponding author. Mailing address: Division of Clinical Pharmacology, Johns Hopkins University School of Medicine, Harvey 502, 600 N. Wolfe St., Baltimore, MD 21287. Phone: (410) 955-9707. Fax: (410) 955-9708. E-mail: chendrix{at}jhmi.com.

Antimicrobial Agents and Chemotherapy, June 2000, p. 1667-1673, Vol. 44, No. 6
0066-4804/00/$04.00+0
Copyright © 2000, American Society for Microbiology. All rights reserved.


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