Pharmacokinetics, Tolerability and Pharmacogenetics of DA-8031 After Multiple Ascending Doses in Healthy Male Subjects

References

• AlthofSE, McMahonCG, WaldingerMD, et al. An update of the international society of sexual medicine’s guidelines for the diagnosis and treatment of premature ejaculation (PE). Sex Med. 2014;2(2):60–90. doi:10.1002/sm2.2825356302
   PubMed Web of Science ®Google Scholar
• AhnTY, ParkJK, LeeSW, et al. Prevalence and risk factors for erectile dysfunction in Korean men: results of an epidemiological study. J Sex Med. 2007;4(5):1269–1276. doi:10.1111/j.1743-6109.2007.00554.x17635695
   PubMed Web of Science ®Google Scholar
• CegliaI, AcconciaS, FracassoC, ColovicM, CacciaS, InvernizziRW. Effects of chronic treatment with escitalopram or citalopram on extracellular 5-HT in the prefrontal cortex of rats: role of 5-HT1A receptors. Br J Pharmacol. 2004;142(3):469–478. doi:10.1038/sj.bjp.070580015148253
   PubMed Web of Science ®Google Scholar
• GiulianoF, ClementP. Serotonin and premature ejaculation: from physiology to patient management. Eur Urol. 2006;50(3):454–466. doi:10.1016/j.eururo.2006.05.05516844284
   PubMed Web of Science ®Google Scholar
• DemirY, BalciN, GurbuzM. Differential effects of selective serotonin reuptake inhibitors on paraoxonase-1 enzyme activity: an in vitro study. Comp Biochem Physiol C Toxicol Pharmacol. 2019;226:108608. doi:10.1016/j.cbpc.2019.10860831422163
   PubMed Web of Science ®Google Scholar
• OzaslanMS, BalciN, DemirY, GurbuzM, KufreviogluOI. Inhibition effects of some antidepressant drugs on pentose phosphate pathway enzymes. Environ Toxicol Pharmacol. 2019;72:103244. doi:10.1016/j.etap.2019.10324431557707
   PubMed Web of Science ®Google Scholar
• F LaskerG, HalisF, GokceA. Selective serotonin reuptake inhibitors for premature ejaculation: review of erectile and ejaculatory side effects. Curr Drug Saf. 2014;9(2):118–126. doi:10.2174/157488630966614012009584624446888
   PubMedGoogle Scholar
• McMahonC, KimSW, ParkNC, et al. Treatment of premature ejaculation in the Asia-Pacific region: results from a Phase III double-blind, parallel-group study of dapoxetine. J Sex Med. 2010;7(1 Pt 1):256–268. doi:10.1111/j.1743-6109.2009.01560.x19878447
   PubMed Web of Science ®Google Scholar
• MironeV, ArcanioloD, RivasD, et al. Results from a prospective observational study of men with premature ejaculation treated with dapoxetine or alternative care: the PAUSE study. Eur Urol. 2014;65(4):733–739. doi:10.1016/j.eururo.2013.08.01823993257
   PubMed Web of Science ®Google Scholar
• BuvatJ, TesfayeF, RothmanM, RivasDA, GiulianoF. Dapoxetine for the treatment of premature ejaculation: results from a randomized, double-blind, placebo-controlled Phase 3 trial in 22 countries. Eur Urol. 2009;55(4):957–967. doi:10.1016/j.eururo.2009.01.02519195772
   PubMed Web of Science ®Google Scholar
• WaldingerMD. Treatment of premature ejaculation with selective serotonin re-uptake inhibitors. In: Premature Ejaculation. Milano: Springer; 2013:229–240.
   Google Scholar
• WaldingerMD, SchweitzerDH, OlivierB. On-demand SSRI treatment of premature ejaculation: pharmacodynamic limitations for relevant ejaculation delay and consequent solutions. J Sex Med. 2005;2(1):121–131. doi:10.1111/j.1743-6109.2005.20112.x16422915
   PubMed Web of Science ®Google Scholar
• FergusonJM. SSRI antidepressant medications; Adverse effects and tolerability. Prim Care Companion J Clin Psychiatry. 2001;3(1):22–27. doi:10.4088/pcc.v03n010515014625
   PubMedGoogle Scholar
• SahanA, CubukA, OzkaptanO, et al. Comparison of the safety and efficacy of the on-demand use of sertraline, dapoxetine, and daily use of sertraline in the treatment of patients with lifelong premature ejaculation: a prospective randomised study. Andrologia. 2020;52(11):e13854. doi:10.1111/and.1385433113277
   PubMed Web of Science ®Google Scholar
• KangKK, SungJH, KimSH, LeeS. Effect of DA-8031, a novel oral compound for premature ejaculation, on male rat sexual behavior. Int J Urol. 2014;21(3):325–329. doi:10.1111/iju.1225623968141
   PubMed Web of Science ®Google Scholar
• ShinD, LeeS, YiS, et al. Pharmacokinetics and tolerability of DA-8031, a novel selective serotonin reuptake inhibitor for premature ejaculation in healthy male subjects. Drug Des Devel Ther. 2017;11:713–723. doi:10.2147/DDDT.S126861
   PubMed Web of Science ®Google Scholar
• HicksJK, BishopJR, SangkuhlK, et al. Clinical pharmacogenetics implementation consortium (CPIC) guideline for CYP2D6 and CYP2C19 genotypes and dosing of selective serotonin reuptake inhibitors. Clin Pharmacol Ther. 2015;98(2):127–134. doi:10.1002/cpt.14725974703
   PubMed Web of Science ®Google Scholar
• Pharmacogene Variation Consortium. CYP3A4 allele nomenclature; Available from: https://www.pharmvar.org/gene/CYP3A4. Accessed 511, 2021.
   Google Scholar
• MaekawaK, YoshimuraT, SaitoY, et al. Functional characterization of CYP3A4.16: catalytic activities toward midazolam and carbamazepine. Xenobiotica. 2009;39(2):140–147. doi:10.1080/0049825080261774619255940
   PubMed Web of Science ®Google Scholar
• BirdwellKA, DeckerB, BarbarinoJM, et al. Clinical pharmacogenetics implementation consortium (CPIC) guidelines for CYP3A5 Genotype and tacrolimus dosing. Clin Pharmacol Ther. 2015;98(1):19–24. doi:10.1002/cpt.11325801146
   PubMed Web of Science ®Google Scholar
• ByeonJY, KimYH, LeeCM, et al. CYP2D6 allele frequencies in Korean population, comparison with East Asian, Caucasian and African populations, and the comparison of metabolic activity of CYP2D6 genotypes. Arch Pharm Res. 2018;41(9):921–930. doi:10.1007/s12272-018-1075-630191460
   PubMed Web of Science ®Google Scholar
• DorjiPW, TsheringG, Na-BangchangK. CYP2C9, CYP2C19, CYP2D6 and CYP3A5 polymorphisms in South-East and East Asian populations: a systematic review. J Clin Pharm Ther. 2019;44(4):508–524. doi:10.1111/jcpt.1283530980418
   PubMed Web of Science ®Google Scholar
• AlhadabAA, BrundageRC. Population pharmacokinetics of sertraline in healthy subjects: a model-based meta-analysis. AAPS J. 2020;22(4):73. doi:10.1208/s12248-020-00455-y32430638
   PubMed Web of Science ®Google Scholar
• HiemkeC. Paroxetine: pharmacokinetics and pharmacodynamics. Fortschr Neurol Psychiatr. 1994;62(Suppl 1):2–8. doi:10.1055/s-2007-10023547959522
   PubMed Web of Science ®Google Scholar
• UnoT, AkamineY, Yasui-FurukoriN, HiranoT. Effects of selective serotonin reuptake inhibitors on the pharmacokinetics of proton pump inhibitors. Neuropsychiatry. 2017;7(4).
   Google Scholar
• FunkKA, BostwickJR. A comparison of the risk of QT prolongation among SSRIs. Ann Pharmacother. 2013;47(10):1330–1341. doi:10.1177/106002801350199424259697
   PubMed Web of Science ®Google Scholar
• U.S. Food and Drug Administration. FDA drug safety communication: abnormal heart rhythms associated with high doses of Celexa (citalopram hydrobromide); 2017. Available from: https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-revised-recommendations-celexa-citalopram-hydrobromide-related. Accessed 1118, 2021.
   Google Scholar
• MaljuricNM, NoordamR, AartsN, et al. Use of selective serotonin re-uptake inhibitors and the heart rate corrected QT interval in a real-life setting: the population-based Rotterdam Study. Br J Clin Pharmacol. 2015;80(4):698–705. doi:10.1111/bcp.1268125966843
   PubMed Web of Science ®Google Scholar
• BeachSR, KostisWJ, CelanoCM, et al. Meta-analysis of selective serotonin reuptake inhibitor–associated QTc prolongation. J Clin Psychiatry. 2014;75(5):e441–e449. doi:10.4088/JCP.13r0867224922496
   PubMed Web of Science ®Google Scholar
• U.S. Department of Health and Human Services. Common terminology criteria for adverse events (CTCAE) ver 5.0. 2017. Available from: https://ctep.cancer.gov/protocoldevelopment/electronic_applications/ctc.htm#ctc_50. Accessed November 18, 2021.
   Google Scholar