Evaluation of the Excretion of Fosfomycin Into Breast Milk Following a Single Intravenous Dose of… (NCT07618299) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Evaluation of the Excretion of Fosfomycin Into Breast Milk Following a Single Intravenous Dose of ZTI-01 (6 g) in Healthy Lactating Women
24 participantsStarted 2026-07
Plain-language summary
Evaluation of the Excretion of Fosfomycin into Breast Milk Following a Single Intravenous Dose of ZTI-01 (6 g) in Healthy Lactating Women
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participant must be 18 to 45 years of age inclusive, at the time of signing the informed consent.
. Participant is a healthy lactating female, who is actively breastfeeding (including baby to breast, bottle feeding mother's expressed breast milk) and is at least 12 weeks postpartum of a healthy term (≥ 37 weeks gestational age) newborn infant (no medical complications) and not more than 1 years postpartum. Lactation must be well established prior to the day of admission to inpatient unit.
. Participant is overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and 12-lead ECG at screening.
. Participant is willing to temporarily discontinue breastfeeding their infant and discard all their breast milk for 5 consecutive days, including (day of admission to inpatient unit (Day -1), day of dosing while in the inpatient unit (Day 1), and 3 consecutive days after dose (including the day of discharge from the inpatient unit and 2 days at home; Days 2 to 4); and willing to store sufficient amount of breastmilk (e.g., breast milk pumped and stored in freezer before the day of admission), and/or infant formula to feed infant during these 5 consecutive days.
. Participant must not be in the process of weaning before admission to inpatient unit and have maintained an adequate breast milk supply (according to Investigator discretion) with regularly pumping or routine breastfeeding (e.g., pumping or feeding 3-4 times a day) at admission.
. Participant has a body mass index (BMI) within the range 18 to 35 kg/m2 (inclusive)
. Participant is either sexually inactive (abstinent) or, if sexually active, must agree to use/practice one of the acceptable birth control methods listed in Section 10.3 beginning before or during the screening period prior to the first dose, throughout the inpatient stay, and for 3 days following the dose.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Area under the concentration-time curve for drug concentrations in breast milk from time 0 to 24 hours (AUC0-24h,milk)
Timeframe: 0-24 hours post dose
2
Maximum observed drug concentration in breast milk (Cmax,milk)
Timeframe: 0-24 hours post dose
3
Time to reach the maximum observed drug concentration in breast milk (Tmax,milk)
Timeframe: 0-24 hours post dose
4
Average drug concentration in breast milk (Cave,milk), calculated as AUC₀-24h, milk divided by Tau (τ)
Timeframe: 0-24 hours post dose
5
Total amount of drug in breast milk over a period of 24 hours (Ammilk, mg/day) following a single dose
Timeframe: 0-24 hours post dose
Trial details
NCT IDNCT07618299
SponsorMeitheal Pharmaceuticals, Inc.
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2027-08
Contact for this trial
Meitheal Pharmaceuticals, Inc. Meitheal Pharmaceuticals, Inc.
. Signed informed consent as described in Section 10.1.1.3 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion criteria
. Participant is pregnant or plans to become pregnant during the course of the study.
. Sensitivity to any of the study interventions, or components thereof, or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.
. History or presence of cardiovascular, respiratory, psychiatric, metabolic, hepatic, renal, gastrointestinal, endocrinological, hematological, oncological, or neurological disorders determined to be clinically significant by the Investigator.
. History or presence of any condition that in the opinion of the Investigator would constitute a risk when taking the study intervention or interfere with the interpretation of data.
. History or presence of drug or alcohol abuse or current alcohol use \> 21 units of alcohol per week (1 unit is equal to approximately 330 mL of beer, 1 small glass \[200 mL\] of wine, or 1 measure \[25 mL\] of spirits).
. History or regular use of tobacco- or nicotine-containing products within 6 months prior to screening with the exception of casual smokers (i.e., \< 5 cigarettes per week).
. Has history of mastitis within 30 days, breast cancer and/or has had a mastectomy or lumpectomy with the exception of a benign fibroma or lipoma removal at the investigator's discretion; and/or a clinically significant abnormality observed in either breast during a clinical breast exam at Screening or Admission (Day -1).
. Past or intended use of prescription medication within 14 days or over-the-counter medication including herbal medications within 7 days prior to dosing (apart from vitamin/mineral supplements or occasional paracetamol).