Pharmacokinetics, absorption, and excretion of radiolabeled revexepride: a Phase I clinical trial using a microtracer and accelerator mass spectrometry-based approach

References

• El-SeragHBSweetSWinchesterCCDentJUpdate on the epidemiology of gastro-oesophageal reflux disease: a systematic reviewGut201463687188023853213
   PubMed Web of Science ®Google Scholar
• VakilNvan ZantenSVKahrilasPDentJJonesRThe Montreal definition and classification of gastroesophageal reflux disease: a global evidence-based consensusAm J Gastroenterol2006101819001920 quiz 194316928254
   PubMed Web of Science ®Google Scholar
• KatzPOTutuianRHistamine receptor antagonists, proton pump inhibitors and their combination in the treatment of gastro-oesophageal reflux diseaseBest Pract Res Clin Gastroenterol200115337138411403533
   PubMed Web of Science ®Google Scholar
• FassRGasiorowskaARefractory GERD: what is it?Curr Gastroenterol Rep200810325225718625135
   PubMedGoogle Scholar
• ShaheenNJAdlerJDedrieSRandomised clinical trial: the 5-HT4 agonist revexepride in patients with gastro-oesophageal reflux disease who have persistent symptoms despite PPI therapyAliment Pharmacol Ther201541764966125693609
   PubMed Web of Science ®Google Scholar
• VelaMFCamacho-LobatoLSrinivasanRTutuianRKatzPOCastellDOSimultaneous intraesophageal impedance and pH measurement of acid and nonacid gastroesophageal reflux: effect of omeprazoleGastroenterology200112071599160611375942
   PubMed Web of Science ®Google Scholar
• HershcoviciTFassRManagement of gastroesophageal reflux disease that does not respond well to proton pump inhibitorsCurr Opin Gastroenterol201026436737820571388
   PubMed Web of Science ®Google Scholar
• ChampionMCProkinetic therapy in gastroesophageal reflux diseaseCan J Gastroenterol199711Suppl B55B65B
   PubMedGoogle Scholar
• SaegusaYTakedaHMutoSDecreased motility of the lower esophageal sphincter in a rat model of gastroesophageal reflux disease may be mediated by reductions of serotonin and acetylcholine signalingBiol Pharm Bull201134570471121532161
   PubMed Web of Science ®Google Scholar
• De MaeyerJHLefebvreRASchuurkesJAJ5-HT4 receptor agonists: similar but not the sameNeurogastroenterol Motil20082029911218199093
   PubMed Web of Science ®Google Scholar
• Bruley des VarannesSCoronEGalmicheJPShort and long-term PPI treatment for GERD. Do we need more-potent anti-secretory drugs?Best Pract Res Clin Gastroenterol201024690592121126703
   PubMed Web of Science ®Google Scholar
• TackJZerbibFBlondeauKRandomized clinical trial: effect of the 5-HT4 receptor agonist revexepride on reflux parameters in patients with persistent reflux symptoms despite PPI treatmentNeurogastroenterol Motil201527225826825530111
   PubMed Web of Science ®Google Scholar
• PierceDCorcoranMVelinovaMHossackSHoppenbrouwersMMartinPA phase 1 randomized study evaluating the effect of omeprazole on the pharmacokinetics of a novel 5-hydroxytryptamine receptor 4 agonist, revexepride (SSP-002358), in healthy adultsDrug Des Devel Ther2015912571268
   PubMed Web of Science ®Google Scholar
• HahSSHendersonPTTurteltaubKWRecent advances in biomedical applications of accelerator mass spectrometryJ Biomed Sci2009161111
   Google Scholar
• BobbaSDingJChowdhuryGUtilization of AMS and HRMS for metabolite profiling and identification of [¹⁴C]Revexepride (SSP-002358) in a human microtracer phase 1 study62nd ASMS Conference on Mass Spectrometry and Allied TopicsJune 15–19, 2014Baltimore, MD
   Google Scholar
• Food and Drug Administration (FDA). Center for Drug Evaluation and Research (CDER). Guidance for industryBioanalytical method validation2001 Available from: http://www.fda.gov/downloads/Drugs/.../Guidances/ucm070107.pdfAccessed January 26, 2016
   Google Scholar
• VogelJSRapid production of graphite without contamination for biomedical AMSRadiocarbon1992343344350
   Web of Science ®Google Scholar
• RoffeySJObachRSGedgeJISmithDAWhat is the objective of the mass balance study? A retrospective analysis of data in animal and human excretion studies employing radiolabeled drugsDrug Metab Rev2007391174317364879
   PubMed Web of Science ®Google Scholar
• VervoortGWillemsHLWetzelsJFAssessment of glomerular filtration rate in healthy subjects and normoalbuminuric diabetic patients: validity of a new (MDRD) prediction equationNephrol Dial Transplant200217111909191312401845
   PubMed Web of Science ®Google Scholar
• De SchryverAMAndriesseGISamsomMSmoutAJGooszenHGAkkermansLMThe effects of the specific 5HT4 receptor agonist, prucalopride, on colonic motility in healthy volunteersAliment Pharmacol Ther200216360361211876716
   PubMed Web of Science ®Google Scholar
• CamilleriMVazquez-RoqueMIBurtonDPharmacodynamic effects of a novel prokinetic 5-HT receptor agonist, ATI-7505, in humansNeurogastroenterol Motil2007191303817187586
   PubMed Web of Science ®Google Scholar
• TackJVosRJanssensJSalterJJauffretSVandeplasscheGInfluence of tegaserod on proximal gastric tone and on the perception of gastric distensionAliment Pharmacol Ther200318101031103714616170
   PubMed Web of Science ®Google Scholar
• TackJCamilleriMChangLSystematic review: cardiovascular safety profile of 5-HT(4) agonists developed for gastrointestinal disordersAliment Pharmacol Ther201235774576722356640
   PubMed Web of Science ®Google Scholar
• MendzelevskiBAusmaJChanterDOAssessment of the cardiac safety of prucalopride in healthy volunteers: a randomized, double-blind, placebo- and positive-controlled thorough QT studyBr J Clin Pharmacol201273220320921848574
   PubMed Web of Science ®Google Scholar
• CombesRDBerridgeTConnellyJEarly microdose drug studies in human volunteers can minimise animal testing: proceedings of a workshop organised by Volunteers in Research and TestingEur J Pharm Sci200319111112729856
   PubMed Web of Science ®Google Scholar
• ArjomandAAccelerator mass spectrometry-enabled studies: current status and future prospectsBioanalysis20102351954120440378
   PubMed Web of Science ®Google Scholar
• BeumerJHGarnerRCCohenMBHuman mass balance study of the novel anticancer agent ixabepilone using accelerator mass spectrometryInvest New Drugs200725432733417347871
   PubMed Web of Science ®Google Scholar
• GianniLKearnsCMGianiANonlinear pharmacokinetics and metabolism of paclitaxel and its pharmacokinetic/pharmacodynamic relationships in humansJ Clin Oncol19951311801907799018
   PubMed Web of Science ®Google Scholar
• KaulSShuklaUABarbhaiyaRHNonlinear pharmacokinetics of nefazodone after escalating single and multiple oral dosesJ Clin Pharmacol19953588308398522641
   PubMed Web of Science ®Google Scholar