PostpartumPhase 4NCT06056583
Drug Excretion in Breast Milk
A Phase 4 study testing Cimetidine 200 MG in people with Postpartum and Lactation, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 days to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Postpartum, Lactation, Drugs in Breast Milk
- What is being tested?
- Cimetidine 200 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2023to 30 Sep 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 days to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy postpartum women
- 18-50 years of age and their infants
- Able to provide written informed consent
Who cannot join
- 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, theophylline,tricyclic antidepressants and warfarin) Patients with drug interactions will be excluded for safety reasons.
- 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.
- 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.
- 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.
- 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.
- Smokers (tobacco or other nicotine containing products Nicotine interacts with OCT1 and will confound data analysis and interpretation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Washington
Seattle, Washington, 98195
Mary F Hebert, PharmD, 206-616-5016, mhebert@uw.edu
About this study
Official title: Postpartum Activity and Expression of BCRP and OCT1 Drug Transporters in the Mammary Gland
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.
Read the detailed description
Each woman will receive a single oral dose of cimetidine 200 mg on each of 3 study days (3-5 weeks, 3-4 months, and 6-8 months postpartum) followed by serial collection of blood, urine and breast milk samples over 12-hours. Cimetidine concentrations will be assay using a validated LC/MS/MS assay. Subjects will be genotyped for OCT1 and BCRP. Mammary epithelial cells will be isolated from breast milk and transporter expression will be quantified. Each woman will serve as her own control.
- Conditions
- Postpartum, Lactation, Drugs in Breast Milk, Mammary Drug Transporters, BCRP, OCT1
- Being tested
- Cimetidine 200 MG
- Keywords
- breast milk, lactation, cimetidine, proteomics, OCT1, BCRP, OCTN2, PEPT2, ENT1, CNT3, MRP1, OATP2B1, OATP3A1, OCT2, postpartum, pharmacokinetics
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cimetidine 200 MGDrug
Also called Tagamet
Cimetidine will serve as the probe drug
| Study group | Role | What they receive |
|---|---|---|
| Healthy Lactating Women | Other | Healthy Lactating Women will be studied on 3 study days and serve as their own control. Receives: Drug: Cimetidine 200 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mammary clearance of cimetidine
Cimetidine excretion into breast milk at three postpartum stages
Measured: 3-5 weeks, 3-4 months and 6-8 months postpartum
Mammary epithelial cell expression of BCRP
BCRP protein expression in MECs at three postpartum stages
Measured: 3-5 weeks, 3-4 months and 6-8 months postpartum
Mammary epithelial cell expression of OCT1
OCT1 protein expression in MECs at three postpartum stages
Measured: 3-5 weeks, 3-4 months and 6-8 months postpartum
Secondary outcomes (13)
Cimetidine relative infant dose and infant concentration
cimetidine relative infant dose (RID) and infant concentration
Measured: 3-5 weeks, 3-4 months and 6-8 months postpartum
Relationship between OCT1 expression and activity
Effect of time postpartum on OCT1 protein expression in MECs and correlation with cimetidine mammary CL
Measured: 3-5 weeks, 3-4 months and 6-8 months postpartum
Maternal cimetidine PK
Effects of time postpartum on cimetidine CL/F
Measured: 3-5 weeks, 3-4 months and 6-8 months postpartum
Maternal cimetidine PK
Effects of time postpartum on cimetidine renal CL
Measured: 3-5 weeks, 3-4 months and 6-8 months postpartum
Maternal cimetidine PK
Effects of time postpartum on cimetidine renal secretion CL
Measured: 3-5 weeks, 3-4 months and 6-8 months postpartum
Maternal cimetidine PK
Effects of time postpartum on cimetidine mammary CL
Measured: 3-5 weeks, 3-4 months and 6-8 months postpartum
Maternal cimetidine PK
Effects of time postpartum on cimetidine AUC
Measured: 3-5 weeks, 3-4 months and 6-8 months postpartum
Maternal cimetidine PK
Effects of time postpartum on cimetidine Cmax
Measured: 3-5 weeks, 3-4 months and 6-8 months postpartum
Maternal cimetidine PK
Effects of time postpartum on cimetidine Tmax
Measured: 3-5 weeks, 3-4 months and 6-8 months postpartum
Maternal cimetidine PK
Effects of time postpartum on cimetidine half-life
Measured: 3-5 weeks, 3-4 months and 6-8 months postpartum
Maternal cimetidine PK
Effects of time postpartum on cimetidine apparent oral volume of distribution
Measured: 3-5 weeks, 3-4 months and 6-8 months postpartum
Maternal cimetidine PK
Effects of time postpartum on cimetidine elimination rate constant
Measured: 3-5 weeks, 3-4 months and 6-8 months postpartum
Relationship between BCRP expression and activity
Effect of time postpartum on BCRP protein expression in MECs and correlation with cimetidine mammary CL
Measured: 3-5 weeks, 3-4 months and 6-8 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start4 Dec 2023
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostpartumStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- This is a phase 1 study design of an approved drug to evaluate the time-course for the expression and activity of OCT1 and BCRP in the mammary gland 3-5 weeks, 3-4 months and 6-8 months postpartum.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Mary Hebert, University of Washington
- Investigators
- Mary Hebert, PharmD, FCCP, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06056583
- Sponsor's protocol ID
- STUDY00018397
- Other IDs
- R01HD112282
- Status last verified
- Aug 2024
- First submitted
- 14 Sep 2023
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: We are committed to share data with the academic community and researcher-at-large. We will adhere to the NIH Grant Policy on Sharing Research Data and Resources. That is, after final data collection and analysis and after full peer review is performed on our data, the de-identified data generated by this project will be made available when requested by the academic community and researchers-at-large contingent upon Material Transfer Agreements with the University of Washington.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postpartum Activity and Expression of BCRP and OCT1 Drug Transporters in the Mammary Gland
- ClinicalTrials.gov ID
- NCT06056583
- Acronym / sponsor ID
- STUDY00018397
- Conditions
- Postpartum, Lactation, Drugs in Breast Milk, Mammary Drug Transporters, BCRP, OCT1
- Keywords
- breast milk, lactation, cimetidine, proteomics, OCT1, BCRP, OCTN2, PEPT2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Each woman will receive a single oral dose of cimetidine 200 mg on each of 3 study days (3-5 weeks, 3-4 months, and 6-8 months postpartum) followed by serial collection of blood, urine and breast milk samples over 12-hours. Cimetidine concentrations will be assay using a validated LC/MS/MS assay. Subjects will be genotyped for OCT1 and BCRP. Mammary epithelial cells will be isolated from breast milk and transporter expression will be quantified. Each woman will serve as her own control.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a phase 1 study design of an approved drug to evaluate the time-course for the expression and activity of OCT1 and BCRP in the mammary gland 3-5 weeks, 3-4 months and 6-8 months postpartum.
| Arm | Type | Receives |
|---|---|---|
| Healthy Lactating Women | Other | Drug: Cimetidine 200 MGHealthy Lactating Women will be studied on 3 study days and serve as their own control. |
Who may qualify
- Ages
- 14 days to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Healthy postpartum women
- 18-50 years of age and their infants
- Able to provide written informed consent
Key exclusion criteria (8 listed)
- 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, theophylline,tricyclic antidepressants and warfarin) Patients with drug interactions will be excluded for safety reasons.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cimetidine 200 MGAlso: TagametCimetidine will serve as the probe drug | Drug | Healthy Lactating Women |
Primary outcome
Mammary clearance of cimetidine
Time frame: 3-5 weeks, 3-4 months and 6-8 months postpartum
Cimetidine excretion into breast milk at three postpartum stages
Mammary epithelial cell expression of BCRP
Time frame: 3-5 weeks, 3-4 months and 6-8 months postpartum
BCRP protein expression in MECs at three postpartum stages
Mammary epithelial cell expression of OCT1
Time frame: 3-5 weeks, 3-4 months and 6-8 months postpartum
OCT1 protein expression in MECs at three postpartum stages
13 secondary outcomes
Cimetidine relative infant dose and infant concentration
Time frame: 3-5 weeks, 3-4 months and 6-8 months postpartum
Relationship between OCT1 expression and activity
Time frame: 3-5 weeks, 3-4 months and 6-8 months postpartum
Maternal cimetidine PK
Time frame: 3-5 weeks, 3-4 months and 6-8 months postpartum
Maternal cimetidine PK
Time frame: 3-5 weeks, 3-4 months and 6-8 months postpartum
Maternal cimetidine PK
Time frame: 3-5 weeks, 3-4 months and 6-8 months postpartum
Maternal cimetidine PK
Time frame: 3-5 weeks, 3-4 months and 6-8 months postpartum
Maternal cimetidine PK
Time frame: 3-5 weeks, 3-4 months and 6-8 months postpartum
Maternal cimetidine PK
Time frame: 3-5 weeks, 3-4 months and 6-8 months postpartum
Maternal cimetidine PK
Time frame: 3-5 weeks, 3-4 months and 6-8 months postpartum
Maternal cimetidine PK
Time frame: 3-5 weeks, 3-4 months and 6-8 months postpartum
Maternal cimetidine PK
Time frame: 3-5 weeks, 3-4 months and 6-8 months postpartum
Maternal cimetidine PK
Time frame: 3-5 weeks, 3-4 months and 6-8 months postpartum
Relationship between BCRP expression and activity
Time frame: 3-5 weeks, 3-4 months and 6-8 months postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Individual participant dataSharing planned: Yes. We are committed to share data with the academic community and researcher-at-large. We will adhere to the NIH Grant Policy on Sharing Research Data and Resources. That is, after final data collection and analysis and after full peer review is performed on our data, the de-identified data generated by this project will be made available when requested by the academic community and researchers-at-large contingent upon Material Transfer Agreements with the University of Washington.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mary Hebert, PharmD, FCCP principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cimetidine 200 MG in people with Postpartum and Lactation, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary Hebert, PharmD, FCCP (206-616-5016, mhebert@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mammary clearance of cimetidine (time frame: 3-5 weeks, 3-4 months and 6-8 months postpartum). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.