Nonclinical Safety Assessment of SYN-004

International Journal of Toxicology

Volumn 35, Issue 3, 2016, Pages 309-316

  Kokai Kun, John F ^a   Andrew Bristol, J ^a   Setser, John ^b   Schlosser, Michael ^c  

^a Synthetic Biologics   (United States)

^b WIL RESEARCH LABORATORIES   (United States)

^c MSR Pharma Services   (United States)

Author keywords

ceftriaxone; oral dosage; pharmacokinetics; toxicity; lactamase

Indexed keywords

BETA LACTAMASE; CEFTRIAXONE; SYN 004; UNCLASSIFIED DRUG; ANTIINFECTIVE AGENT; PROTECTIVE AGENT; RECOMBINANT PROTEIN; SYN-004;

ANIMAL EXPERIMENT; ANIMAL MODEL; ARTICLE; BEAGLE; BILIARY EXCRETION; CONTROLLED STUDY; DRUG ACCUMULATION; DRUG BLOOD LEVEL; DRUG MEGADOSE; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; GOOD LABORATORY PRACTICE; INTESTINE FLORA; MALE; MAXIMUM TOLERATED DOSE; NO-OBSERVED-ADVERSE-EFFECT LEVEL; NONHUMAN; PHARMACOKINETIC PARAMETERS; PRECLINICAL STUDY; PROTECTION; ANIMAL; BILE DUCT; BLOOD; DOG; DRUG INTERACTION; ENTERIC COATED TABLET; INTRAVENOUS DRUG ADMINISTRATION; METABOLISM; ORAL DRUG ADMINISTRATION; TOXICITY TESTING;

ADMINISTRATION, INTRAVENOUS; ADMINISTRATION, ORAL; ANIMALS; ANTI-BACTERIAL AGENTS; BETA-LACTAMASES; BILE DUCTS; CEFTRIAXONE; DOGS; DRUG INTERACTIONS; FEMALE; GASTROINTESTINAL MICROBIOME; MALE; PROTECTIVE AGENTS; RECOMBINANT PROTEINS; TABLETS, ENTERIC-COATED; TOXICITY TESTS, SUBACUTE;

EID: 84966601483     PISSN: 10915818     EISSN: 1092874X     Source Type: Journal    
DOI: 10.1177/1091581815623236     Document Type: Article

References (26)

1. Stevens V, Dumyati G, Fine LS, et al. Cumulative antibiotic exposures over time and the risk of Clostridium difficile infection. Clin Infect Dis. 2011; 53 (1): 42-48.
2. Bartlett JG., Clinical practice. Antibiotic-associated diarrhea. N Engl J Med. 2002; 346 (5): 334-339.
3. Carroll KC, Bartlett JG,. Biology of Clostridium difficile: implications for epidemiology and diagnosis. Annu Rev Microbiol. 2011; 65 (1): 501-521.
4. Drekonja DM, Amundson WH, DeCarolis DD, et al. Antimicrobial use and risk for recurrent Clostridium difficile infection. Am J Med. 2011; 124 (11): 1081.e1-e7.
5. Maudgal DP, Maxwell JD, Lees LJ, et al. Biliary excretion of amoxycillin and ceftriaxone after intravenous administration in man. Br J Clin Pharmacol. 1982; 14 (2): 213-217.
6. Karachalios G, Charalabopoulos K,. Biliary excretion of antimicrobial drugs. Chemotherapy. 2002; 48 (6): 280-297.
7. Hayton WL, Schandlik R, Stoeckel K,. Biliary excretion and pharmacokinetics of ceftriaxone after cholecystectomy. Eur J Clin Pharmacol. 1986; 30 (4): 445-451.
8. Lozupone CA, Stombauch JI, Gordon JI, et al. Diversity, stability and resilience of the human gut microbiotia. Nature. 2012; 489 (7415): 220-230.
9. Lahti L, Salojarvi J, Salonen A, et al. Tipping elements in the human intestinal ecosystem. Nat Commun. 2014; 5: 4344.
10. Nord CE, Kager L, Heimdahl A,. Impact of antimicrobial agents on the gastrointestinal microflora and the risk of infections. Am J Med. 1984; 76 (5A): 99-106.
11. Tarkkanen A, Heinonen T, Jogi R, et al. P1A Recombinant β-lactamase prevents emergence of antimicrobial resistance in gut microflora of healthy subjects during intravenous administration of ampicillin. Antimicrob Agents Chemother. 2009; 53 (6): 2455-2462.
12. Harmoinen J, Vaali K, Koski P, et al. Enzymic degradation of a β-lactam antibiotic, ampicillin, in the gut: a novel treatment modality. J Antimicrob Chemother. 2003; 51 (2): 361-365.
13. Pitout JD,. IPSAT P1A, a class A beta-lactamase therapy for the prevention of penicillin-induced disruption to the intestinal microflora. Curr Opin Investig Drugs. 2009; 10 (8): 838-844.
14. Harmoinen J, Mentula S, Heikkila M, et al. Orally administered targeted recombinant beta-lactamase prevents ampicillin-induced selective pressure on the gut microbiota: a novel approach to reducing antimicrobial resistance. Antimicrob Agents Chemother. 2004; 48 (1): 75-79.
15. Klausner EA, Lavy E, Friedman M, et al. Expandable gastroretentive dosage forms. J Control Release. 2003; 90 (2): 143-162.
16. Martinez MN, Papich MG,. Factors influencing the gastric residence of dosage forms in dogs. J Pharm Sci. 2009; 98 (3): 844-860.
17. Tibbitts J,. Issues related to the use of canines in toxicologic pathology-issues with pharmacokinetics and metabolism. Toxicol Pathol. 2003; 31 (1 suppl): 17-24.
18. ® (ceftriaxone sodium) for Injection. South San Francisco, CA: Genentech USA, Inc. (A Member of the Roche Group). 2015: 1-23.
19. National Research Council of the National Academies. Guide for Care and Use of Laboratory Animals, 8th Edition. Washington, DC. National Academies Press; 2011: 1-246.
20. Evonik. Technical Information: EUDRAGIT L 30 D-55 and EUDRAGIT L 100-55, Summary of Safety Data. Evonik Industries AG. TOX.LD/E 2012: 1-15.
21. Snedecor GW, Cochran WG,. One-Way Classifications; Analysis of Variance: Statistical Methods, 7th ed, Ames, IA: The Iowa State University Press; 1980: 215-237.
22. Dunnett CW,. New tables for multiple comparisons with a control. Biometrics. 1964; 20 (3): 482-491.
23. Sokal RR, Rohlf FJ,. Biometry: The Principles and Practice of Statistics in Biological Research, 2nd ed: San Francisco, CA: W.H. Freeman; 1981: 859.
24. Davies B, Morris T,. Physiological parameters in laboratory animals and humans. Pharm Res. 1993; 10 (7): 1093-1095.
25. Rebuelto M, Albarellos G, Ambros L, et al. Pharmacokinetics of ceftriaxone administered by the intravenous, intramuscular or subcutaneous routes to dogs. J Vet Pharmacol Ther. 2002; 25 (1): 73-76.
26. Popick AC, Crouthamel WG, Bekersky I,. Plasma protein binding of ceftriaxone. Xenobiotica. 1987; 17 (10): 1139-1145.