A Phase 4 interventional study of Zoliflodacin in Lactation, sponsored by Global Antibiotics Research and Development Partnership. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Global Antibiotics Research and Development Partnership · Phase 4, Interventional, and Screening
This is a single-arm clinical trial to evaluate the PK profile in breast milk and plasma after a single oral dose of zoliflodacin in healthy lactating women.
Eligible participants who have been actively breastfeeding or expressing milk for at least 4 weeks postpartum will receive a single dose of zoliflodacin administered as an oral suspension with food.
Breast milk and plasma samples will be collected at predefined time points for up to 48 hours after dosing to characterize zoliflodacin concentrations and estimate drug exposure in breast milk and maternal plasma. Participants will temporarily discontinue breastfeeding from study check-in until 72 hours after dosing to avoid infant exposure to zoliflodacin. Breast milk will be expressed using an electronic breast pump and collected according to the study schedule.
Participants will be admitted to the clinical research unit the day before dosing and discharged after completion of the 48-hour PK sampling period. A follow-up visit will be conducted approximately 7 days after dosing to assess safety and tolerability. A lactation consultant will be available throughout the study period and for up to 30 days after dosing, as needed.
1,081 studies on the registry are indexed under Breast Feeding; 217 are open to participants now.
This study's planned enrollment of 10 is below the median of 100 across 844 interventional studies indexed under Breast Feeding.
Browse Breast Feeding studies →Global Antibiotics Research and Development Partnership is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Zoliflodacin
Oral suspension of Zoliflodacin 3g
Maximum Observed Milk Concentration (Cmax) of Zoliflodacin in human milk
Maximum observed concentration of zoliflodacin in human milk following administration of a single oral 3 g dose of zoliflodacin. Unit: ng/mL
Time frame: Through 48 hours post dose
Time to Maximum Observed Concentration (Tmax) of Zoliflodacin in human milk
Time to reach the maximum observed concentration of zoliflodacin in human milk following administration of a single oral 3 g dose of zoliflodacin. Unit: hours.
Time frame: Through 48 hours post-dose.
Terminal Elimination Half-Life (t½) of Zoliflodacin in human Milk
Terminal elimination half-life of zoliflodacin in human milk following administration of a single oral 3 g dose of zoliflodacin. Unit: hours.
Time frame: Through 48 hours post-dose.
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC₀-∞) of Zoliflodacin in Human Milk
Area under the concentration-time curve from time zero extrapolated to infinity in human milk following administration of a single oral 3 g dose of zoliflodacin. Unit: ng·h/mL
Time frame: Through 48 hours post-dose
Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC₀-last) of Zoliflodacin in Human Milk
Area under the concentration-time curve from time zero to the last quantifiable concentration in human milk following administration of a single oral 3 g dose of zoliflodacin. Unit: ng·h/mL.
Time frame: Through 48 hours post-dose
Area Under the Concentration-Time Curve From Time Zero to 24 Hours (AUC₀-24) of Zoliflodacin in Human Milk
Area under the concentration-time curve from time zero to 24 hours post-dose in human milk following administration of a single oral 3 g dose of zoliflodacin. Unit: ng·h/mL.
Time frame: 24 hours post-dose.
Milk-to-Plasma Ratio for AUC₀-∞ of Zoliflodacin
Ratio of human milk exposure to plasma exposure based on AUC₀-∞ following administration of a single oral 3 g dose of zoliflodacin. Unit: ratio (unitless)
Time frame: Through 48 hours post-dose.
Milk-to-Plasma Ratio for AUC₀-last of Zoliflodacin
Ratio of human milk exposure to plasma exposure based on AUC₀-last following administration of a single oral 3 g dose of zoliflodacin. Unit: ratio (unitless).
Time frame: Through 48 hours post-dose.
Milk-to-Plasma Ratio for AUC₀-24 of Zoliflodacin
Ratio of human milk exposure to plasma exposure based on AUC₀-24 following administration of a single oral 3 g dose of zoliflodacin. Unit: ratio (unitless)
Time frame: 24 hours post-dose
Milk-to-Plasma Ratio for Cmax of Zoliflodacin
Ratio of maximum observed concentration in human milk to maximum observed concentration in plasma following administration of a single oral 3 g dose of zoliflodacin. Unit: ratio (unitless).
Time frame: Through 48 hours post-dose.
Relative Infant Dose (RID) of Zoliflodacin
Estimated relative infant dose of zoliflodacin calculated from measured human milk concentrations and maternal dose following administration of a single oral 3 g dose of zoliflodacin. Unit: %.
Time frame: Through 48 hours post-dose.
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Number of participants experiencing one or more treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events leading to discontinuation, and adverse events considered related to zoliflodacin following administration of a single oral 3 g dose.
Time frame: From dosing through Day 8
Change From Baseline in Systolic Blood Pressure
Change from baseline in systolic blood pressure. Unit: mmHg
Time frame: Baseline through Day 8
Change From Baseline in Diastolic Blood Pressure
Change from baseline in diastolic blood pressure. Unit: mmHg
Time frame: Baseline through Day 8
Change From Baseline in Pulse Rate
Change from baseline in respiratory rate. Unit: Breaths/min
Time frame: Baseline through Day 8
Change From Baseline in Body Temperature
Change from baseline in body temperature. Unit: °C
Time frame: Baseline through Day 8
Clinically Significant Physical Examination Findings
Number of participants with new or worsened clinically significant abnormalities identified during physical examination following administration of a single oral 3 g dose of zoliflodacin.
Time frame: Baseline through Day 8
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Zoliflodacin
Global Antibiotics Research and Development Partnership