Population pharmacokinetics of bedaquiline (TMC207), a novel antituberculosis drug

Antimicrobial Agents and Chemotherapy

Volumn 58, Issue 9, 2014, Pages 5315-5324

  McLeay, Sarah C ^a   Vis, Peter ^b,c   Van Heeswijk, Rolf P G ^b   Green, Bruce ^a  

^a Model Answers Pty Ltd   (Australia)

^b JANSSEN RESEARCH FOUNDATION   (Belgium)

^c LAPandP Consultants BV   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

BEDAQUILINE; TUBERCULOSTATIC AGENT; QUINOLINE DERIVATIVE;

ADOLESCENT; ADULT; ANTIBIOTIC SENSITIVITY; ARTICLE; BLACK PERSON; CHILD; CLINICAL ARTICLE; CONTROLLED STUDY; DISTRIBUTION VOLUME; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG CLEARANCE; DRUG DISPOSITION; DRUG HALF LIFE; FEMALE; HUMAN; HUMAN EXPERIMENT; MALE; MULTIDRUG RESISTANT TUBERCULOSIS; NORMAL HUMAN; PHARMACOKINETICS; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; SEX DIFFERENCE; SIMULATION; STEADY STATE; TISSUE DISTRIBUTION; AGED; BIOAVAILABILITY; CLINICAL TRIAL; HALF LIFE TIME; MIDDLE AGED; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; TUBERCULOSIS, MULTIDRUG-RESISTANT; TUBERCULOSIS, PULMONARY; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; ANTITUBERCULAR AGENTS; BIOLOGICAL AVAILABILITY; DIARYLQUINOLINES; FEMALE; HALF-LIFE; HUMANS; MALE; MIDDLE AGED; TUBERCULOSIS, MULTIDRUG-RESISTANT; TUBERCULOSIS, PULMONARY; YOUNG ADULT;

EID: 84906093266     PISSN: 00664804     EISSN: 10986596     Source Type: Journal    
DOI: 10.1128/AAC.01418-13     Document Type: Article

References (19)

1. Tiruviluamala P, Reichman LB. 2002. Tuberculosis. Annu. Rev. Public Health 23:403-426. http://dx.doi.org/10.1146/annurev.publhealth.23.100901. 140519. (Pubitemid 34508081)
2. World Health Organization. 2011. WHO report 2011: global tuberculosis control. WHO, Geneva, Switzerland. http://www.who.int/tb/publications/global- report/2011/gtbr11-full.pdf.
3. Zignol M, van Gemert W, Falzon D, Sismanidis C, Glaziou P, Floyd K, Raviglione M. 2011. Surveillance of anti-tuberculosis drug resistance in the world: an updated analysis, 2007-2010. Bull. World Health Organ. 90:111D-119D. http://dx.doi.org/10.2471/BLT.11.092585.
4. CDC. 2006. Emergence of Mycobacterium tuberculosis with extensive resistance to second-line drugs-worldwide, 2000-2004. MMWR Morb. Mortal. Wkly. Rep. 55:301-305.
5. Andries K, Verhasselt P, Guillemont J, Göhlmann HW, Neefs JM, Winkler H, Van Gestel J, Timmerman P, Zhu M, Lee E, Williams P, de Chaffoy D, Huitric E, Hoffner S, Cambau E, Truffot-Pernot C, Lounis N, Jarlier V. 2005. A diarylquinoline drug active on the ATP synthase of Mycobacterium tuberculosis. Science 307:223-227. http://dx.doi.org/10.1126/science.1106753. (Pubitemid 40116230)
6. FDA. 2012. Anti-infective drugs advisory committee meeting: briefing document. TMC207 (bedaquiline) treatment of patients with MDR-TB: NDA 204-384. FDA, Silver Spring, MD. http://www.fda.gov/downloads/Advisory Committees/CommitteesMeetingMaterials/Drugs/Anti-InfectiveDrugs AdvisoryCommittee/UCM329260.pdf.
7. Svensson EM, Aweeka F, Park JG, Marzan F, Dooley KE, Karlsson MO. 2013. Model-based estimates of the effects of efavirenz on bedaquiline pharmacokinetics and suggested dose adjustments for patients coinfected with HIV and tuberculosis. Antimicrob. Agents Chemother. 57:2780- 2787. http://dx.doi.org/10.1128/AAC.00191-13.
8. Cockcroft DW, Gault MH. 1976. Prediction of creatinine clearance from serum creatinine. Nephron 16:31-41. http://dx.doi.org/10.1159/000180580.
9. Center for Drug Evaluation and Research. 2001. Guidance for industry: bioanalytical method validation. FDA, U.S. Department of Health and Human Services, Rockville, MD. http://www.fda.gov/downloads/Drugs/Guidances/ucm070107. pdf.
10. Karlsson MO, Savic RM. 2007. Diagnosing model diagnostics. Clin. Pharmacol. Ther. 82:17-20. http://dx.doi.org/10.1038/sj.clpt.6100241. (Pubitemid 46944205)
11. Du Bois D, Du Bois EF. 1989. A formula to estimate the approximate surface area if height and weight be known. 1916. Nutrition 5:303-311.
12. Bonate P. 2006. Pharmacokinetic-pharmacodynamic modeling and simulation. Springer, New York, NY.
13. Hanumegowda UM, Wenke G, Regueiro-Ren A, Yordanova R, Corradi JP, Adams SP. 2010. Phospholipidosis as a function of basicity, lipophilicity, and volume of distribution of compounds. Chem. Res. Toxicol. 23:749-755. http://dx.doi.org/10.1021/tx9003825.
14. Rustomjee R, Diacon AH, Allen J, Venter A, Reddy C, Patientia RF, Mthiyane TCP, De Marez T, van Heeswijk R, Kerstens R, Koul A, De Beule K, Donald PR, McNeeley DF. 2008. Early bactericidal activity and pharmacokinetics of the diarylquinoline TMC207 in treatment of pulmonary tuberculosis. Antimicrob. Agents Chemother. 52:2831-2835. http://dx.doi.org/10.1128/AAC.01204-07.
15. Barroso EC, Pinheiro VG, Façanha MC, Carvalho MR, Moura ME, Campelo CL, Peloquin CA, Guerrant RL, Lima AA. 2009. Serum concentrations of rifampin, isoniazid, and intestinal absorption, permeability in patients with multidrug resistant tuberculosis. Am. J. Trop. Med. Hyg. 81:322-329.
16. Pinheiro VG, Ramos LM, Monteiro HS, Barroso EC, Bushen OY, Façanha MC, Peloquin CA, Guerrant RL, Lima AA. 2006. Intestinal permeability and malabsorption of rifampin and isoniazid in active pulmonary tuberculosis. Braz. J. Infect. Dis. 10:374-379. http://dx.doi.org/10.1590/S1413-86702006000600003. (Pubitemid 46585565)
17. Zhu M, Namdar R, Stambaugh JJ, Starke JR, Bulpitt AE, Berning SE, Peloquin CA. 2002. Population pharmacokinetics of ethionamide in patients with tuberculosis. Tuberculosis (Edinb.) 82:91-96. (Pubitemid 35155424)
18. Han PY, Kirkpatrick CM, Green B. 2009. Informative study designs to identify true parameter-covariate relationships. J. Pharmacokinet. Pharmacodyn. 36:147-163. http://dx.doi.org/10.1007/s10928-009-9115-y.
19. McLeay SC, Morrish GA, Kirkpatrick CM, Green B. 2012. The relationship between drug clearance and body size: systematic review and meta-analysis of the literature published from 2000 to 2007. Clin. Pharmacokinet. 51:319-330. http://dx.doi.org/10.2165/11598930-000000000-00000.