Evaluating drug excretion in breast milk after cimetidine administration
Postpartum Activity and Expression of BCRP and OCT1 Drug Transporters in the Mammary Gland
This study tests how the drug cimetidine passes into breast milk in healthy new mothers to see if genetics affect how it's transported.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 14 Days to 50 Years |
| Sex | All |
| Sponsor | University of Washington Academic / other |
| Drugs / interventions | afatinib, axitinib, imatinib, lapatinib, nilotinib, sunitinib, telatinib, trametinib |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT06056583 on ClinicalTrials.gov |
What this trial studies
This study investigates how the drug cimetidine is excreted in breast milk among healthy postpartum women. Participants will receive a single oral dose of cimetidine at three different postpartum time points, with blood, urine, and breast milk samples collected for analysis. The study aims to assess the expression and activity of specific transporters in the mammary gland, using each participant as their own control. Genotyping for OCT1 and BCRP will also be performed to understand genetic influences on drug transport.
Who should consider this trial
Good fit: Ideal candidates are healthy postpartum women aged 18-50 who can provide informed consent.
Not a fit: Patients with known hypersensitivity to cimetidine or those on medications that interact with it may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the safety of drug use during lactation for breastfeeding mothers and their infants.
How similar studies have performed: While studies on drug excretion in breast milk exist, this specific approach focusing on cimetidine and transporter expression is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria 1. Healthy postpartum women 2. 18-50 years of age and their infants 3. Able to provide written informed consent Exclusion criteria 1. Receiving cimetidine within the 3 days prior to each study day. Concomitant administration of cimetidine will confound interpretation of study results. 2. Hypersensitivity to cimetidine Patients with known allergic reactions to cimetidine will be excluded for safety reasons 3. Receiving medication known to interact with cimetidine: OCT, BCRP, CYP3A4, CYP2D6, CYP1A2 and CYP2C9 substrates (e.g. amiodarone, clopidogrel, diazepam, ketoconazole, metformin, nifedipine, phenytoin, procainamide, theophylline,tricyclic antidepressants and warfarin) Patients with drug interactions will be excluded for safety reasons. 4. Receiving BCRP inhibitors/inducers (afatinib, aripipraxole, axitinib, cimetidine, cyclosporine, curcumin/tumeric, delavirdine, efavirenz, elacridar, elvitegravir, etravirine, FTC, 5-fluorouracil, fluvastatin, imatinib, lanzoprazole, lapatinib, lopinavir, maraviroc, nelfinavir, nebicapone, nilotinib, novobiocin, oltipraz, omeprazole, pantoprazole, phenobarbital, promazine, rabeprazole, riboflavin, rifampicin, risperidone, saquinavir, sirolimus, sorafenib, sulfasalazine, sunitinib, tacrolimus, tariquidar, telaprevir, telatinib, teriflunomide, tolcapone, triflunomide, trametinib, trifluoperazine, venlafaxine, zidonuvir), OCT1 inhibitors/inducers (acyclovir, amantadine, amiloride, amitriptyline, bucindolol, carvedilol, chlorpheniramine, chlorpromazine, cimetidine, citalopram, clonidine, clopidogrel, clotrimazole, clozapine, cocaine, corticosterone, cyclosporine, daclatasvir, darunavir, desipramine, dextromethorphan, diltiazem, disopyramide, dronedarone, efavirenz, famotidine, fentanyl, fluvoxamine, formoterol, fuloxetine, griseofulvin, doxazosine, ganciclovir, guanfacine, imipramine, indinavir, isavuconazole, itraconazole, ketoconazole, lamotrigine, lasmiditan, levofloxacin, levomepromazine, lidocaine, maprotiline, methylnicotinamide, morphine, moxifloxacin, nefazodone, nelfinavir, nevirapine, nicotine, nomifensine, ondansetron, oxybutynin, paroxetine, pentamidine, phenoxybenzamine, prazosin, probenecid, procainamide, propafenone, pyrazinamide, quetiapine,quinidine, quinine, reboxetine, remoxidpride, reseripine, rifampicin, ritonavir, salmeterol, saquinavir, tramadol, trimethoprim, trimipramine, verapamil) Inhibitors and inducers of the drug transporters will confound data analysis and interpretation. 5. Kidney disease could confound data analysis and interpretation. Therefore, patients with known kidney disease with documented renal function impairment will be excluded from the study. Current serum creatinine \> 1.2 mg/dL in their medical record will be excluded. 6. Known liver disease Liver disease will confound data analysis and interpretation. Therefore, patients with known significant liver disease will be excluded from the study. Current ALT exceeding 2-times the upper limit of normal in their medical record will be excluded. 7. Inability to fast for 4 hours prior to the study. To limit PK variability across study days, subjects will be requested to fast for 4 hours prior to each study day. 8. Smokers (tobacco or other nicotine containing products Nicotine interacts with OCT1 and will confound data analysis and interpretation
Where this trial is running
Seattle, Washington
- University of Washington — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Mary Hebert, PharmD, FCCP — University of Washington
- Study coordinator: Mary Hebert, PharmD, FCCP
- Email: mhebert@uw.edu
- Phone: 206-616-5016
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.