Drug Excretion in Breast Milk

• Status: Recruiting
• Trial end date: 2028-09-30
• Target enrollment: 0
• Participant gender: Female

Summary

This is a prospective, non-randomized, phase I study design evaluating the in vivo activities and expression of OCT1 and BCRP in mammary gland of lactating women at three time points postpartum.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Washington
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Cimetidine

Criteria

Inclusion Criteria:

• Study participants will include: healthy, lactating or pregnant and planning to breastfeed their infant, between 18-50 years of age, female and their nursing infant 3 weeks-8 months of age.

Exclusion Criteria:

• • Age <18 or > 50 years old.

• Smokers

• Following multiple gestation (twins, triplets etc.)

• Allergy to cimetidine

• Pregnancy

• Receiving medications that could lead to a drug interaction e.g.

• A: antacids, alprazolam, amphetamines, atazanavir, acalabrutinib, alosetron, amiodarone, amitriptyline, azelastine, amoxapine, alfuzosin,

• B: bisacodyl, bupropion, bosutinib,

• C: citalopram, chloroquine, codeine, clozapine, carmustine, clopidogrel, cyclosporine, carvedilol, cannabis, cefpodoxime, ceftibuten, clomipramine, cefditoren, chlordiazepoxide, chlorpromazine, cholecalciferol, cisapride, clonazepam, clorazepate, clomethiazole, carbamazepine,

• D: dofetilide, dihydrocodeine, duloxetine, delavirdine, dasatinib, domperidone, dothiepin, dilevalol, diltiazem, dutasteride, desipramine, doxepin, diazepam,

• E: escitalopram, epirubicin, eliglustat, estazolam, ethanol (on study day), ergocalciferol,

• F: fezolinetant, fluorouracil, finerenone, fexinidazole, flecainide, fluconazole, flurazepam, fosamprenavir, femoxetine,

• G: gefitinib, glipizide, glyburide, gliclazide, glimepiride,

• H: hydroxychloroquine, halazepam,

• I: infigratinib, imipramine, itraconazole,

• K: ketoconazole,

• L: ledipasvir, lornoxicam, labetalol, lidocaine, levoketoconazole, levomethadyl, lomitapide, loratadine,

• M: meperidine, morphine, mirtazapine, midazolam, metformin, metoclopramide, memantine, metronidazole, moclobemide,

• N: neratinib, nicotine, nebivolol, nisoldipine, nifedipine, nortriptyline, nimodipine, nicardipine, nilotinib, nitrazepam, nilvadipine, nitrendipine,

• O: oxycodone, octreotide, oxymorphone,

• P: posaconazole, piperaquine, pazopanib, pentoxifylline, paroxetine, phenytoin, pramipexole, propranolol, procainamide, phenindione, perfloxacin, praziquantel, protriptyline, prazepam, pontinib,

• Q: quinidine, quazepam, quinine,

• R: rilpivirine, roflumilast, risperidone, risedronate,

• S: succinylcholine, selpercatinib, sirolimus, secretin, sotorasib, sparsentan, sofobuvir, saquinavir, sertraline, sucralfate, sildenafil,

• T: terbinafine, tramadol, theophylline, tacrolimus, tizanidine, tolazoline, trimetrexate, tocainide, tamsulosin, timolol, tacrine, tolbutamide, trimipramine, tamoxifen, trimazosin, tinidazole, triazolam,

• V: vismodegib, verapamil, velpatasvir, venlafaxine, vardenafil,

• W: warfarin,

• Z: zalcitabine, zaleplon, zolmitriptan

• BCRP inhibitors: dasatinib, celecoxib, erlotinib, lopinavir, fostamatinib, docetaxel, barcitinib, imatinib, gefitnib, venetoclax, sunitinib, elacridar, Palbociclib, regorafenib, rucaparib, nilotinib, sorafenib, vemurafenib, afatinib, nelfinavir, paclitaxel, quercetin and alectinib

• BCRP inducers: venlafaxine, and dovitinib

• OCT inhibitors: trimethoprim, ranitidine, codeine, rocuronium, ganciclovir, acyclovir, dinoprostone, progesterone, prazosin, phenoxybenzamine, phenformin, procainamide, nicotine, choline, verapamil, quinine, pancuronium, disopyramide, desipramine, guanidine, probenecid, saquinavir, nelfinavir, chlorpheniramine, indinavir, reserpine, rucaparib, estradiol, pitolisant, choline, quinidine, amantadine, dexchlorpheniramine, doxazosin, efavirenz, nevirapine, clopidogrel, dacomitinib, gilteritinib, palbociclib, linagliptin, nintedanib, dronedarone, lasmiditan, formoterol, guanfacine, salmeterol, levofloxacin, osilodrostat, lurbinectedin, tirbanibulin cyproheptadine, infigratinib, atagepant, asciminib, abrocitinib, pacritinib, olaparib, tepotinib, tafenoquine, propranolol, oxprenolol, metoprolol, quinine, thiamine, norepinephrine, imipramine, grepafloxacine, amantadine, metformin, desipramine, famotidine, probenecid, cisplatin, quinacrine, amiloride, epinephrine, disopyramide, diphenhydramine, imatinib, flurazepam, bupropion, amiodarone, clopidogrel, cocaine, lamotrigine

• OCT inducers: none identified