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New treatment option for Postpartum
Official title Drug Excretion in Breast Milk
ClinicalTrials.gov ID: NCT06056583
What this study is testing
What is Cimetidine 200 MG?
Cimetidine 200 MG is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for postpartum.
Also referred to as Tagamet.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 to 50. Healthy volunteers may be eligible.
You may be able to join if
- Healthy postpartum women
- 18-50 years of age and their infants
- Able to provide written informed consent
You likely can't join if
- Receiving cimetidine within the 3 days prior to each study day. Concomitant administration of cimetidine will confound interpretation of study...
- Hypersensitivity to cimetidine Patients with known allergic reactions to cimetidine will be excluded for safety reasons
- Receiving medication known to interact with cimetidine: OCT, BCRP, CYP3A4, CYP2D6, CYP1A2 and CYP2C9 substrates (e.g. amiodarone, clopidogrel...
- Receiving BCRP inhibitors/inducers (afatinib, aripipraxole, axitinib, cimetidine, cyclosporine, curcumin/tumeric, delavirdine, efavirenz, elacridar...
- Kidney disease could confound data analysis and interpretation. Therefore, patients with known kidney disease with documented renal function...
- Known liver disease Liver disease will confound data analysis and interpretation. Therefore, patients with known significant liver disease will be...
See the full eligibility criteria
- Healthy postpartum women
- 18-50 years of age and their infants
- Able to provide written informed consent
- Receiving cimetidine within the 3 days prior to each study day. Concomitant administration of cimetidine will confound interpretation of study results.
- Hypersensitivity to cimetidine Patients with known allergic reactions to cimetidine will be excluded for safety reasons
- 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...
- Receiving BCRP inhibitors/inducers (afatinib, aripipraxole, axitinib, cimetidine, cyclosporine, curcumin/tumeric, delavirdine, efavirenz, elacridar, elvitegravir, etravirine, FTC, 5-fluorouracil, fluvastatin, imatinib...
- 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...
- 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...
- Inability to fast for 4 hours prior to the study. To limit PK variability across study days, people will be requested to fast for 4 hours prior to each study day.
- Smokers (tobacco or other nicotine containing products Nicotine interacts with OCT1 and will confound data analysis and interpretation
The study team makes the final eligibility decision.
Where it's taking place
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 14 days to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.