Maraviroc modelling strategy: Use of early phase 1 data to support a semi-mechanistic population pharmacokinetic model

British Journal of Clinical Pharmacology

Volumn 68, Issue 3, 2009, Pages 355-369

  Weatherley, Barry ^a   McFadyen, Lynn ^a  

^a PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United Kingdom)

Author keywords

Maraviroc; NONMEM; Semi mechanistic pharmacokinetic model

Indexed keywords

MARAVIROC; PLACEBO;

AREA UNDER THE CURVE; ARTICLE; CLINICAL TRIAL; DOSE RESPONSE; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISPOSITION; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG EXCRETION; DRUG FECES LEVEL; DRUG MECHANISM; DRUG METABOLISM; DRUG SAFETY; DRUG URINE LEVEL; FIRST PASS EFFECT; HUMAN; ISOTOPE LABELING; KIDNEY CLEARANCE; LIVER BLOOD FLOW; LIVER CLEARANCE; MAXIMUM PLASMA CONCENTRATION; PRIORITY JOURNAL; SINGLE DRUG DOSE; TABLET FORMULATION;

ADMINISTRATION, ORAL; ANTI-HIV AGENTS; CLINICAL TRIALS, PHASE I AS TOPIC; CYCLOHEXANES; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HIV INFECTIONS; HUMANS; INJECTIONS, INTRAVENOUS; MALE; METABOLIC CLEARANCE RATE; MODELS, BIOLOGICAL; MODELS, STATISTICAL; TRIAZOLES;

EID: 69949173682     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/j.1365-2125.2009.03455.x     Document Type: Article

References (20)

1. Wood A, Armour D. The discovery of the CCR5 receptor antagonist, UK-427 857, a new agent for the treatment of HIV infection and AIDS. Prog Med Chem 2005 43 : 239 271.
2. Fätkenheuer G, Pozniak AL, Johnson MA, Plettenberg A, Staszewski S, Hoepelman AI, Saag MS, Goebel FD, Rockstroh JK, Dezube BJ, Jenkins TM, Medhurst C, Sullivan JF, Ridgway C, Abel S, James IT, Youle M, van der Ryst E. Efficacy of short-term monotherapy with maraviroc, a new CCR5 antagonist, in patients infected with HIV-1. Nature Med 2005 11 : 1170 1172.
3. Gulick RM, Lalezari J, Goodrich J, Clumeck N, DeJesus E, Horban A, Nadler J, Clotet B, Karlsson A, Wohlfeiler M, Montana JB, McHale M, Sullivan J, Ridgway C, Felstead S, Dunne MW, van der Ryst E, Mayer H. Maraviroc for previously treated patients with R5 HIV-1 infection. N Engl J Med 2008 359 : 1429 1441.
4. Kashuba ADM. Drug-drug interactions and the pharmacotherapy of HIV infection. Top HIV Med 2005 13 : 64 9.
5. Robertson SM, Penzak SR, Pau AK. Drug interactions in the management of HIV infection. Expert Opin Pharmacother 2005 6 : 233 253.
6. Abel S, van der Ryst E, Rosario MC, Ridgway CE, Medhurst CG, Taylor-Worth RJ, Muirhead GJ. Assessment of the pharmacokinetics, safety and tolerability of maraviroc, a novel CCR5 antagonist, in healthy volunteers. Br J Clin Pharmacol 2008 65 (Suppl. 1 5 18.
7. Abel S, Russell D, Whitlock LA, Ridgway CE, Nedderman ANR, Walker DK. Assessment of the absorption, metabolism and absolute bioavailability of maraviroc in healthy male subjects. Br J Clin Pharmacol 2008 65 (Suppl. 1 60 7.
8. Hyland R, Jones B, Muirhead G. In vitro assessment of the CYP-based drug-drug interaction potential of UK-427 857. 5th International Workshop on Clinical Pharmacology of HIV Therapy; 1-3 April 2004; Rome, Italy.
9. Walker DK, Abel S, Comby P, Muirhead GJ, Nedderman AN, Smith DA. Species differences in the disposition of the CCR5 antagonist, UK-427 857, a new potential treatment for HIV. Drug Metab Dispos 2005 33 : 587 595.
10. Abel S, Beaumont KC, Crespi CL, Eve MD, Fox L, Hyland R, Jones BC, Muirhead GJ, Smith DA, Venn RF, Walker DK. Potential role for P-glycoprotein in the non-proportional pharmacokinetics of UK-343,664 in man. Xenobiotica 2001 31 : 665 676.
11. Chan PLS, Weatherley B, McFadyen L. A population pharmacokinetic meta-analysis of Maraviroc in healthy volunteers and asymptomatic HIV-infected subjects. Br J Clin Pharmacol 2008 65 (Suppl. 1 76 85.
12. Weatherley B, McFadyen L, Chan PLS, Marshall S. Population pharmacokinetic covariate analysis of maraviroc in the MERIT study in treatment naïve subjects. 9th International Workshop on Clinical Pharmacology of HIV Therapy; 7-9 April 2008; New Orleans, USA.
13. Weatherley B, McFadyen L, Chan PLS, Marshall S. Population pharmacokinetic covariate analysis of maraviroc in phase 2b/3 studies in treatment experienced (TE) HIV-1 infected subjects on optimized background therapy (OBT). 9th International Workshop on Clinical Pharmacology of HIV Therapy; 7-9 April 2008; New Orleans, USA.
14. McFadyen L, Jacqmin P, Wade JR, Weatherley B. Maraviroc exposure-efficacy (<50 copies/mL) analysis in HIV-1 infected treatment-naïve subjects - ITT population (MERIT study). XV11 International Aids Conference. 3-8 August 2008; Mexico City, Mexico.
15. th European Aids Conference. 24-27 October 2007; Madrid, Spain.
16. McFadyen L, Jacqmin P, Wade JR, Weatherley B. Maraviroc exposure-safety biomarker (transaminases and creatine kinase) analyses in MOTIVATE 1 and 2 studies in HIV-1 infected treatment-experienced subjects. XV11 International Aids Conference. 3-8 August 2008; Mexico City, Mexico.
17. Beal SL, Sheiner LB (Editors). NONMEM Users Guides. Icon Development Solutions, Ellicott City, Maryland, 1989-1998.
18. S-PLUS 6 for Windows User's Guide, Insightful Corporation, Seattle, WA.
19. th Meeting of the Population Approach Group Europe. 14-16 June 2006; Brugge, Belgium.
20. Chan PLS, Weatherley B, McFadyen L, Abel S. Impact of concomitant interacting drugs on maraviroc pharmacokinetics after oral tablet administration. 8th International Workshop on Clinical Pharmacology of HIV Therapy. 16-18 April 2007; Budapest, Hungary.