Pharmacokinetics of Oral Zoliflodacin 3 g in Healthy Lactating Women
NCT07926997, Phase 4, Not yet recruiting, Global Antibiotics Research and Development Partnership
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Pharmacokinetics of Oral Zoliflodacin 3 g in Healthy Lactating Women | ClinicalTrials.gov |
| NCT number | NCT07926997 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 4 | ClinicalTrials.gov |
| Enrollment | 10 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Global Antibiotics Research and Development Partnership | ClinicalTrials.gov |
| Conditions | Lactation | ClinicalTrials.gov |
| Interventions | Zoliflodacin | ClinicalTrials.gov |
| First posted | 2026-11-09 | ClinicalTrials.gov |
| Last updated | 2026-11-09 | ClinicalTrials.gov |
Registered outcomes 17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Maximum Observed Milk Concentration (Cmax) of Zoliflodacin in human milk | 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 | ClinicalTrials.gov |
| Primary | Time to Maximum Observed Concentration (Tmax) of Zoliflodacin in human milk | 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. | ClinicalTrials.gov |
| Primary | Terminal Elimination Half-Life (t½) of Zoliflodacin in human Milk | 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. | ClinicalTrials.gov |
| Primary | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC₀-∞) of Zoliflodacin in Human Milk | 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 | ClinicalTrials.gov |
| Primary | Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC₀-last) of Zoliflodacin in Human Milk | 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. | ClinicalTrials.gov |
| Primary | Area Under the Concentration-Time Curve From Time Zero to 24 Hours (AUC₀-24) of Zoliflodacin in Human Milk | 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. | ClinicalTrials.gov |
| Primary | Milk-to-Plasma Ratio for AUC₀-∞ of Zoliflodacin | 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) | ClinicalTrials.gov |
| Primary | Milk-to-Plasma Ratio for AUC₀-last of Zoliflodacin | 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). | ClinicalTrials.gov |
| Primary | Milk-to-Plasma Ratio for AUC₀-24 of Zoliflodacin | 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) | ClinicalTrials.gov |
| Primary | Milk-to-Plasma Ratio for Cmax of Zoliflodacin | 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). | ClinicalTrials.gov |
| Primary | Relative Infant Dose (RID) of Zoliflodacin | 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: %. | ClinicalTrials.gov |
| Secondary | Incidence of Treatment-Emergent Adverse Events (TEAEs) | From dosing through Day 8 | 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Systolic Blood Pressure | Baseline through Day 8 | Change from baseline in systolic blood pressure. Unit: mmHg | ClinicalTrials.gov |
| Secondary | Change From Baseline in Diastolic Blood Pressure | Baseline through Day 8 | Change from baseline in diastolic blood pressure. Unit: mmHg | ClinicalTrials.gov |
| Secondary | Change From Baseline in Pulse Rate | Baseline through Day 8 | Change from baseline in respiratory rate. Unit: Breaths/min | ClinicalTrials.gov |
| Secondary | Change From Baseline in Body Temperature | Baseline through Day 8 | Change from baseline in body temperature. Unit: °C | ClinicalTrials.gov |
| Secondary | Clinically Significant Physical Examination Findings | Baseline through Day 8 | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)