First administration to man of Org 25435, an intravenous anaesthetic: A Phase 1 Clinical Trial

BMC Anesthesiology

Volumn 10, Issue , 2010, Pages

  Rigby Jones, Ann E ^a   Sneyd, J Robert ^a   Vijn, Peter ^b   Boen, Patrick ^b   Cross, Maurice ^c  

^a PLYMOUTH UNIVERSITY PENINSULA SCHOOLS OF MEDICINE AND DENTISTRY   (United Kingdom)

^b MERCK RESEARCH LABORATORIES   (United States)

^c Veeda Clinical Research   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ANESTHETIC AGENT; ORG 25435; PROPOFOL; UNCLASSIFIED DRUG;

ANESTHETIC RECOVERY; ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFICACY; DRUG HALF LIFE; DRUG INFUSION; DRUG SAFETY; DRUG TOLERABILITY; HUMAN; HYPOTENSION; INTRAVENOUS ANESTHESIA; MALE; NORMAL HUMAN; PHASE 1 CLINICAL TRIAL; TACHYCARDIA;

EID: 77953946045     PISSN: None     EISSN: 14712253     Source Type: Journal    
DOI: 10.1186/1471-2253-10-10     Document Type: Article

References (16)

1. Franks NP, Lieb WR. Molecular and cellular mechanisms of general anaesthesia. Nature 1994, 367:607-14. 10.1038/367607a0, 7509043.
2. Jurd R, Arras M, Lambert S, Drexler B, Siegwart R, Crestani F, Zaugg M, Vogt KE, Ledermann B, Antkowiak B, Rudolph U. General anesthetic actions in vivo strongly attenuated by a point mutation in the GABA(A) receptor beta3 subunit. Faseb J 2003, 17:250-2.
3. Albertson TE, Walby WF, Joy RM. Modification of GABA-mediated inhibition by various injectable anesthetics. Anesthesiology 1992, 77:488-99. 10.1097/00000542-199209000-00014, 1519787.
4. Anderson A, Belelli D, Bennett DJ, Buchanan KI, Casula A, Cooke A, Feilden H, Gemmell DK, Hamilton NM, Hutchinson EJ, Lambert JJ, Maidment MS, McGuire R, McPhail P, Miller S, Muntoni A, Peters JA, Sansbury FH, Stevenson D, Sundaram H. Alpha-amino acid phenolic ester derivatives: novel water-soluble general anesthetic agents which allosterically modulate GABA(A) receptors. J Med Chem 2001, 44:3582-91. 10.1021/jm010903i, 11606122.
5. Anderson A, Boyd AC, Byford A, Campbell AC, Gemmell DK, Hamilton NM, Hill DR, Hill-Venning C, Lambert JJ, Maidment MS, May V, Marshall RJ, Peters JA, Rees DC, Stevenson D, Sundaram H. Anesthetic activity of novel water-soluble 2 beta-morpholinyl steroids and their modulatory effects at GABAA receptors. J Med Chem 1997, 40:1668-81. 10.1021/jm960733n, 9171876.
6. Bennett DJ, Anderson A, Buchanan K, Byford A, Cooke A, Gemmell DK, Hamilton NM, Maidment MS, McPhail P, Stevenson DFM, Sundaram H, Vijn P. Novel water soluble 2,6-dimethoxyphenyl ester derivatives with intravenous anaesthetic activity. Bioorganic and Medicinal Chemistry Letters 2003, 13:1971-5. 10.1016/S0960-894X(03)00346-9, 12781176.
7. Varvel JR, Donoho DL, Shafer SL. Measuring the predictive performance of computer-controlled infusion pumps. J Pharmacokinet Biopharm 1992, 20:63-94. 10.1007/BF01143186, 1588504.
8. Wright PM. Population based pharmacokinetic analysis: why do we need it; what is it; and what has it told us about anaesthetics?. Br J Anaesth 1998, 80:488-501.
9. Beal SL, Sheiner LB. NONMEM User's Guide. 1999, San Francisco: University of California.
10. Sneyd JR. Excitatory events associated with propofol anaesthesia: a review. J R Soc Med 1992, 85:288-91. 1294609, 1433094.
11. Wada DR, Bjorkman S, Ebling WF, Harashima H, Harapat SR, Stanski DR. Computer simulation of the effects of alterations in blood flows and body composition on thiopental pharmacokinetics in humans. Anesthesiology 1997, 87:884-99. 10.1097/00000542-199710000-00024, 9357892.
12. Hughes MA, Glass PS, Jacobs JR. Context-sensitive half-time in multicompartment pharmacokinetic models for intravenous anesthetic drugs. Anesthesiology 1992, 76:334-41. 10.1097/00000542-199203000-00003, 1539843.
13. Bailey JM. Context-sensitive half-times: what are they and how valuable are they in anaesthesiology?. Clin Pharmacokinet 2002, 41:793-9. 10.2165/00003088-200241110-00001, 12190329.
14. Marsh B, White M, Morton N, Kenny GN. Pharmacokinetic model driven infusion of propofol in children. Br J Anaesth 1991, 67:41-8. 10.1093/bja/67.1.41, 1859758.
15. Homer TD, Stanski DR. The effect of increasing age on thiopental disposition and anesthetic requirement. Anesthesiology 1985, 62:714-24. 10.1097/00000542-198506000-00004, 4003792.
16. Campbell GA, Morgan DJ, Kumar K, Crankshaw DP. Extended blood collection period required to define distribution and elimination kinetics of propofol. Br J Clin Pharmacol 1988, 26:187-90. 1386527, 3264711.