Pharmacokinetic interaction study between the new antiepileptic and CNS drug RWJ-333369 and carbamazepine in healthy adults

Epilepsia

Volumn 47, Issue 11, 2006, Pages 1830-1840

  Chien, Suchean ^a   Bialer, Meir ^b,c,e   Solanki, Bhavna ^a   Verhaeghe, Tom ^d   Doose, Dennis R ^a   Novak, Gerald ^a   Yao, Caiping ^a  

^a JOHNSON AND JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT   (United States)

^b Faculty of Medicine   (Israel)

^c HEBREW UNIVERSITY OF JERUSALEM   (Israel)

^d JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

^e HEBREW UNIVERSITY OF JERUSALEM   (Israel)

Author keywords

Carbamazepine; Healthy subjects; New antiepileptic drug; Pharmacokinetic interaction; RWJ 333369

Indexed keywords

2 O CARBAMOYL 1 (2 CHLOROPHENYL)ETHANOL; ANTICONVULSIVE AGENT; CARBAMAZEPINE; DRUG METABOLITE; GLUCURONIDE; R 289876; RWJ 333369; UNCLASSIFIED DRUG;

ABDOMINAL PAIN; ACCOMMODATION; ADULT; ANOREXIA; AREA UNDER THE CURVE; ARTICLE; ASTHENIA; BIOEQUIVALENCE; CENTRAL NERVOUS SYSTEM; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIARRHEA; DIPLOPIA; DIZZINESS; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG ERUPTION; DRUG FEVER; DRUG HALF LIFE; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; DYSMENORRHEA; FATIGUE; FEMALE; FLATULENCE; FLU LIKE SYNDROME; GASTROENTERITIS; HEART PALPITATION; HUMAN; HYPESTHESIA; INCREASED APPETITE; INJURY; INSOMNIA; LIBIDO DISORDER; LYMPHADENOPATHY; MALE; MASTALGIA; MENTAL INSTABILITY; MULTIPLE DRUG DOSE; NAUSEA; NORMAL HUMAN; OPEN STUDY; PAIN; PARESTHESIA; PHARYNGITIS; PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RIGOR; SKIN DISEASE; SOMNOLENCE; SPEECH DISORDER; STEADY STATE; THOUGHT DISORDER; UPPER RESPIRATORY TRACT INFECTION; VERTIGO; VISUAL DISORDER; VOMITING; XEROSTOMIA;

ADULT; ANTICONVULSANTS; AREA UNDER CURVE; CARBAMATES; CARBAMAZEPINE; CIRCADIAN RHYTHM; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; DRUG DESIGN; DRUG INTERACTIONS; DRUGS, INVESTIGATIONAL; FEMALE; HALF-LIFE; HUMANS; MALE; MIDDLE AGED; NEUROTRANSMITTER AGENTS;

EID: 33750960656     PISSN: 00139580     EISSN: 15281167     Source Type: Journal    
DOI: 10.1111/j.1528-1167.2006.00815.x     Document Type: Article

References (15)

1. Burstein AH, Horton RL, Dunn T. (2000) Lack of effect of St. John's Wort on carbamazepine pharmacokinetics in healthy volunteers. Clin Pharmacol Ther 68:605-612.
2. Chien S, Yao C, Choi Y, Solanki B, Verhaeghe, Doose D, Novak G. (2005) Drug-drug interaction study between RWJ-333369 and carbamazepine in healthy adults. Epilepsia 46(suppl. 8):181 (abstract).
3. Grabenstatter HL, Dudek FE. (2004) The use of chronic models in antiepileptic drug discovery: The effect of RWJ-333369 on spontaneous motor seizures in rats with kainite-induced epilepsy. Epilepsia 45(suppl. 7):197(abstract).
4. Kasteleijn-Nolst-Trenite DGA, Guerrine R, French JA, Hirsh E, M J-P, Meyer B-U, Abou-Khalil BW, Rosenfeld WE, Gibson D. (2004) Proof of principle in the novel antiepileptic drug RWJ-333369. Seventh Eilat Conference on New Antiepileptic Drugs (EILAT VII). 40(abstract).
5. Lin JH, Wong BK. (2002) Complexities of glucuronidation affecting in vitro-in vivo extrapolation. Curr Drug Metab 3:623-646.
6. Mannens GSJ, Hendrickz J, Janssen C, Chein S, Van Hoof B, Vergaeghe T, Kao M, Kelley MF, Goris I, Goris M, Bockx M, Verreet B, Bialer M, Meuldermans W. The absorption, metabolism and excretion of the novel neuromodulator RWJ-333369 in man. (In press).
7. May TW, Rambeck B, Jurgens U. (1996) Serum concentrations of lamotrigine on epileptic patients: the influence of dose and comedication. Ther Drug Monit 18:523-531.
8. Moller SE, Larsen F, Khant AZ, Rolan PE. (2001) Lack of effect of citalopram on the steady-state pharmacokinetics of carbamazepine in healthy male subjects. J Clin Psychopharmacol. 21:493-499.
9. Nehling A, Rigoulot M-A, Boehrer A. (2005) A new drug, RWJ-333369, displays potent antiepileptic properties in genetic models of absence and audiogenic epilepsy. Epilepsia 46(suppl. 8):215 (abstract).
10. Pellock JM, Perhach JL, Sofia RD. (2002) Felbamate. In Levy RH, Mattson RH, Meldrum BS, Perucca E. (Eds) Antiepileptic drugs. 5th ed. Lippincott, Philadelphia, pp. 301-318.
11. Perucca E, Levy RH. (2002) General principles - combination therapy and drug interactions. In Levy RH, Mattson RH, Meldrum BS, et al. (Eds) Antiepileptic drugs. 5th ed., Lippincott, Philadelphia, pp. 96-102.
12. Thompson CD, Kinter MT, Macdonald TL. (1996) Synthesis and in vitro reactivity of 3-carbamoyl-2-phenylopropionaldehyde and 2-phenylopropenal: putative reactive metabolites of felbamate. Chem Res Toxicol 9:1225-1229.
13. Yamaoka K, Nakagawa T, Uno T. (1978) Statistical moments in pharmacokinetics. J Pharmacokinet Biopharm. 6:547-558.
14. Yao C, Choi Y, Lee J, Doose D, Novak G. (2005) RWJ-333369 pharmacokinetics are linear following single and repeat oral administration in healthy adult men. Epilepsia 46(suppl 8):92 (abstract).
15. Yao C, Doose DR, Novak G, Bialer M. (2006) Pharmacokinetics of the new antiepileptic and CNS drug RWJ-333369 following single and multiple dosing to humans. Epilepsia 47:1822-1829.