LactationPhase 4NCT07926997
Pharmacokinetics of Oral Zoliflodacin 3 g in Healthy Lactating Women
A Phase 4 study testing Zoliflodacin in people with Lactation, run by Global Antibiotics Research and Development Partnership at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lactation
- What is being tested?
- Zoliflodacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Aug 2027
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Woman with good general health status, as determined by medical history, physical examination, laboratory tests, vital signs, and clinical judgment at Screening and check-in
- Age ≥18 to ≤45 years at the time of signing the informed consent
- Weight ≥50 kg at Screening and check-in
- Given birth to a single, healthy, clinically stable, full-term (37 to 42 weeks' gestation) infant in the past 6 weeks to 24 months before Day 1
- Agrees to not breastfeed her infant from check-in until 72 hours after zoliflodacin administration
- Has well-established lactation (ie, at least 4 weeks postpartum) and is breastfeeding her infant; supplemental infant formula use is allowable, and the extent of use of formula will be documented
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- Has confirmed that her breastfed infant is able to feed from a bottle
- Agrees to collect all breast milk from predose through 2 days after the trial drug administration using an electric pump
- Has a negative pregnancy test at Screening and check-in
- Has sufficient venous access to allow for collection of plasma samples
- Agrees to use a highly effective form of contraception (see Section 5.4) with male sexual partners during the trial and for at least 28 days after the zoliflodacin dose
- Agrees to comply with all protocol requirements
- Agrees not to participate in other research trials involving investigational medication or medical devices for the duration of this trial
- Provides written informed consent
Who cannot join
- History of breast implants, breast augmentation, or breast reduction surgery that, in the investigator's opinion, may have a clinical impact on breast milk expression
- Evidence of acute or chronic condition that, in the investigator's opinion, may have a clinical impact on breast milk expression
- Active mastitis within 30 days before Day 1
- Current breast abscess or cracked/bleeding nipples
- History of inadequate lactation
- Moderate or severe hepatic or renal impairment, or other clinically significant medical condition that, in the investigator's opinion, might affect zoliflodacin PK or participant safety
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- Known hypersensitivity to zoliflodacin or formulation excipients
- Positive pregnancy test at Screening or check-in
- Positive NAAT result for N gonorrhoeae at Screening
- Positive serologic test for HIV-1 or HIV-2 antibody, hepatitis B surface antigen, or hepatitis C antibody at Screening. Participants whose results are compatible with prior hepatitis B vaccination (positive hepatitis B surface antibody, negative hepatitis B core antibody, and negative hepatitis B surface antigen) may be included
- Use of zoliflodacin within 30 days before Day 1
- Use of a moderate or strong inducer or inhibitor of CYP3A4, P-glycoprotein, BCRP, or OATP transporters within 14 days or 5 half-lives, whichever is longer, before Day 1
- Consumption of grapefruit, grapefruit juice, or similar citrus fruits (like Seville oranges and pomelos) within 14 days before Day 1
- Current use of tobacco or nicotine-containing products
- Known or suspected drug abuse
- A positive drug or alcohol screen result at Screening or on Day -1
- Participants must not donate blood within 30 days or donate plasma within 7 days before Day 1
- Participation in an interventional clinical trial within 30 days or 5 half-lives of the trial drug, whichever is longer, before Day 1
- Any condition or circumstance that, in the investigator's judgment, may pose a risk to the participant or interfere with protocol adherence (including the 72-hour breastfeeding interruption), assessment of trial objectives, or ability to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Open-label Study to Evaluate the Pharmacokinetics of a Single Oral Dose of Zoliflodacin 3 g in Milk and Plasma in Healthy Lactating Women
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.
Read more
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.
- Conditions
- Lactation
- Being tested
- Zoliflodacin
- Keywords
- PHARMACOKINETICS, LACTATION, BREASTFEEDING
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZoliflodacinDrug
Oral suspension of Zoliflodacin 3g
| Study group | Role | What they receive |
|---|---|---|
| Zoliflodacin | Experimental | Not described Receives: Drug: Zoliflodacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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).
Measured: 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)
Measured: 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).
Measured: 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: %.
Measured: Through 48 hours post-dose.
Secondary outcomes (6)
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.
Measured: From dosing through Day 8
Change From Baseline in Systolic Blood Pressure
Change from baseline in systolic blood pressure. Unit: mmHg
Measured: Baseline through Day 8
Change From Baseline in Diastolic Blood Pressure
Change from baseline in diastolic blood pressure. Unit: mmHg
Measured: Baseline through Day 8
Change From Baseline in Pulse Rate
Change from baseline in respiratory rate. Unit: Breaths/min
Measured: Baseline through Day 8
Change From Baseline in Body Temperature
Change from baseline in body temperature. Unit: °C
Measured: 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.
Measured: Baseline through Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2026
- Study startDec 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LactationStudies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label, single arm
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Global Antibiotics Research and Development Partnership
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07926997
- Sponsor's protocol ID
- STI_PMR_Zoli008
- Status last verified
- Nov 2026
- First submitted
- 22 Oct 2026
- Last updated
- 9 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study to Evaluate the Pharmacokinetics of a Single Oral Dose of Zoliflodacin 3 g in Milk and Plasma in Healthy Lactating Women
- ClinicalTrials.gov ID
- NCT07926997
- Acronym / sponsor ID
- STI_PMR_Zoli008
- Conditions
- Lactation
- Keywords
- PHARMACOKINETICS, LACTATION, BREASTFEEDING
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Global Antibiotics Research and Development PartnershipUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 9 Nov 2026 (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 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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label, single arm
| Arm | Type | Receives |
|---|---|---|
| Zoliflodacin | Experimental | Drug: Zoliflodacin |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Woman with good general health status, as determined by medical history, physical examination, laboratory tests, vital signs, and clinical judgment at Screening and check-in
- Age ≥18 to ≤45 years at the time of signing the informed consent
- Weight ≥50 kg at Screening and check-in
- Given birth to a single, healthy, clinically stable, full-term (37 to 42 weeks' gestation) infant in the past 6 weeks to 24 months before Day 1
- Agrees to not breastfeed her infant from check-in until 72 hours after zoliflodacin administration
Key exclusion criteria (19 listed)
- History of breast implants, breast augmentation, or breast reduction surgery that, in the investigator's opinion, may have a clinical impact on breast milk expression
- Evidence of acute or chronic condition that, in the investigator's opinion, may have a clinical impact on breast milk expression
- Active mastitis within 30 days before Day 1
- Current breast abscess or cracked/bleeding nipples
- History of inadequate lactation
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 |
|---|---|---|
| ZoliflodacinOral suspension of Zoliflodacin 3g | Drug | Zoliflodacin |
Primary outcome
Maximum Observed Milk Concentration (Cmax) of Zoliflodacin in human milk
Time frame: Through 48 hours post dose
Maximum observed concentration of zoliflodacin in human milk following administration of a single oral 3 g dose of zoliflodacin. Unit: ng/mL
Time to Maximum Observed Concentration (Tmax) of Zoliflodacin in human milk
Time frame: Through 48 hours post-dose.
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.
Terminal Elimination Half-Life (t½) of Zoliflodacin in human Milk
Time frame: Through 48 hours post-dose.
Terminal elimination half-life of zoliflodacin in human milk following administration of a single oral 3 g dose of zoliflodacin. Unit: hours.
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC₀-∞) of Zoliflodacin in Human Milk
Time frame: Through 48 hours post-dose
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
Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC₀-last) of Zoliflodacin in Human Milk
Time frame: Through 48 hours post-dose
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.
Area Under the Concentration-Time Curve From Time Zero to 24 Hours (AUC₀-24) of Zoliflodacin in Human Milk
Time frame: 24 hours post-dose.
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.
Milk-to-Plasma Ratio for AUC₀-∞ of Zoliflodacin
Time frame: Through 48 hours post-dose.
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)
Milk-to-Plasma Ratio for AUC₀-last of Zoliflodacin
Time frame: Through 48 hours post-dose.
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).
Milk-to-Plasma Ratio for AUC₀-24 of Zoliflodacin
Time frame: 24 hours post-dose
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)
Milk-to-Plasma Ratio for Cmax of Zoliflodacin
Time frame: Through 48 hours post-dose.
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).
Relative Infant Dose (RID) of Zoliflodacin
Time frame: Through 48 hours post-dose.
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: %.
6 secondary outcomes
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: From dosing through Day 8
Change From Baseline in Systolic Blood Pressure
Time frame: Baseline through Day 8
Change From Baseline in Diastolic Blood Pressure
Time frame: Baseline through Day 8
Change From Baseline in Pulse Rate
Time frame: Baseline through Day 8
Change From Baseline in Body Temperature
Time frame: Baseline through Day 8
Clinically Significant Physical Examination Findings
Time frame: Baseline through Day 8
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 9 Nov 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 Zoliflodacin in people with Lactation, run by Global Antibiotics Research and Development Partnership 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 14 inclusion and 19 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: opening soon, as of the sponsor's last update on 9 Nov 2026. 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 Jovana Albig, MD (+41 22 555 19 90, info@gardp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Observed Milk Concentration (Cmax) of Zoliflodacin in human milk (time frame: Through 48 hours post dose). The study lists 11 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 9 Nov 2026.