Vulvovaginal CandidiasisPhase 1NCT06954493
Pharmacokinetic Study in Healthy Lactating Women Exposed to Ibrexafungerp
A Phase 1 study testing Ibrexafungerp in people with Vulvovaginal Candidiasis and Candida Infection, run by Scynexis, Inc. at 1 site in United States.
Trial summary
This is a pharmacokinetic evaluation of lactating women after receiving two doses of Ibrexafungerp. The study population included healthy lactating females who were at least 10 days postpartum with a fully established milk supply and were between the ages of 18 and 50 years at the time of screening Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vulvovaginal Candidiasis, Candida Infection, Vaginal Candidiasis
- What is being tested?
- Ibrexafungerp
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2023to 1 Nov 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- A healthy lactating woman aged 18 to 50 years, inclusive, at Screening
- At least 10-days postpartum after uncomplicated delivery with a full milk supply established. (There is no specific length of time postpartum)
- Actively breastfeeding or expressing breast milk
- willing to temporarily discontinue breast feeding their infant before the Day 1 morning dose through to 108 hours after the first dose (approximately 4.5 days) AND has the ability to pump breast milk and to provide a reserve for infant feeding, with acceptance of bottle feeding, prior to the study OR has decided to discontinue breastfeeding permanently but has not yet started weaning their infant with acceptance of bottle feeding and must have adequate milk supply
- Has a Body Mass Index (BMI) ≤34 kg/m2 at the screening visit. BMI is calculated by taking the participant's weight in kg and dividing by the participant's height in meters, squared.
- willing to fully express breast milk from both breasts during the duration of the milk collection portion of the study
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- Is judged to be in good health based on medical history, physical examination, vital sign measurements, and laboratory safety tests (all within laboratory normal ranges or changes outside the normal range judged to be clinically non-significant by the investigator) performed at the screening visit and prior to administration of the initial dose of study drug
- Has no clinically significant abnormality on electrocardiogram (ECG) performed at the screening visit
- Has been a non-smoker (including vaping) or a light smoker (less than 10 cigarettes per day) for at least 6 months
- Understands the study procedures and agrees to participate in the study by giving written informed consent
- Is willing to comply with the study restrictions and participate for the full length of the study for a complete summary of study restrictions
- Is not pregnant and highly unlikely to become pregnant
Who cannot join
- Is pregnant or unwilling or unable to comply with the lifestyle guidelines presented in the protocol during the study period and through the Post-Study visit
- Has evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric (including post-natal depression), neurologic, allergic disease (including drug allergies, but excluding untreated asymptomatic, seasonal allergies at time of dosing), or a history of neoplastic disease or any active cancer
- Is mentally or legally incapacitated
- Has a history of any illness or clinical findings that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the participant or infant by participation in the study
- Anticipates the use of prescription or non-prescription drugs that are strong CYP3A4 inducers, including vitamins, herbal and dietary supplements (including St. John's Wort) within 7 days of study drug administration (or 14 days if the drug is a potential enzyme inducer)
- Is unable to refrain from consumption of grapefruit juice, grapefruits, grapefruit products, star fruit, Seville and blood oranges, apple and mulberry juice as well as vegetables from the mustard green family (eg, kale, broccoli, watercress, collard greens, kohlrabi, Brussels sprouts, and mustard), charbroiled meats, and fenugreek beginning approximately 7 days prior to administration of the initial dose of study drug and throughout the participant's stay in the clinic
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- Consumes significant amounts of alcohol, defined as greater than 2 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer [284 mL/10 ounces], wine [125 mL/4 ounces] or distilled spirits [25 mL/1 ounce]) per day. Participant is unable to refrain from all alcohol consumption within one week prior to study dosing throughout the study until the final study visit
- Consumes excessive amounts of caffeine for one month prior to study drug administration, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola or other caffeinated beverages per day
- Has had major surgery, donated or lost 1 unit of blood (approximately 500 mL) or participated in another investigational study within 30 days or 5½ half-lives of the investigational product prior to the screening. The 30-day window will be derived from the date of the last study procedure (ie, poststudy, AE follow-up, etc.) in the previous study to the screening visit of the current study
- Has a history of significant multiple and/or severe allergies [including latex allergy, but with exception of seasonal rhinitis (hay fever)] or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
- Has a known hypersensitivity to ibrexafungerp
- Is currently a user including illicit drugs or has a history of drug (including alcohol) abuse within approximately 1 year
- Is unable to abstain from strenuous exercise from the screening visit until administration of the initial dose of study drug, throughout the study until the poststudy visit
Trial locations and contacts
1 site in 1 country.
United States1 site
Woodland Research Northwest (WRN)
Rogers, Arkansas, 72758
About this study
Official title: Phase 1, Open-Label Pharmacokinetic Study in Healthy Lactating Women After Two Oral Doses of Ibrexafungerp Administered on a Single Day
This is a pharmacokinetic evaluation of lactating women after receiving two doses of Ibrexafungerp. The study population included healthy lactating females who were at least 10 days postpartum with a fully established milk supply and were between the ages of 18 and 50 years at the time of screening
Read the detailed description
This was a Phase 1 study designed to evaluate the pharmacokinetics of ibrexafungerp after administration of two oral doses in lactating women to determine whether ibrexafungerp is excreted in breast milk, and if so, to characterize ibrexafungerp PK in the breast milk and plasma of lactating women.
Participants received a single day of twice daily (BID) 300-mg (2 x 150-mg) oral ibrexafungerp doses given 12 hours apart (Q12H). Participants received both doses on site. Participants were admitted to the clinic on Day 1 and discharged on Day 5, after the 108-hour procedures were completed.
- Being tested
- Ibrexafungerp
- Keywords
- VVC, Thrush, BREXAFEMME, Candidiasis, Vaginal Yeast, Yeast Infection, Lactating, Fungal Disease, Fungal Infection
- Medical subject headings
- Candidiasis, Vulvovaginal, Candidiasis, Candidiasis, Oral, Mycoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbrexafungerpDrug
Ibrexafungerp Oral Tablet
| Study group | Role | What they receive |
|---|---|---|
| Open Label Treatment | Other | Participants received a single day of twice daily (BID) 300-mg (2 x 150-mg) oral ibrexafungerp doses given 12 hours apart (Q12H) Receives: Drug: Ibrexafungerp |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCY-078 Breast Milk Concentrations.
To determine the levels of SCY-078 in breast milk in ng/mL, starting pre-dose (Baseline) on Day 1 until 108 hours post first dose. Concentrations of SCY-078 in milk is measured pre-dose, and in milk collected at the following post-dose intervals: 0-2 hours, 2-4 hours, 4-8 hours, 8-12 hours, 12-18 hours, 18-24 hours, 24-36 hours, 36-48 hours, 48-72 hours and 72-108 hours.
Measured: Pre-dose up to 108 hours post first dose
SCY-078 Plasma Concentrations.
To measure the levels of SCY-078 in plasma at pre-dose (0 hours), 2, 6, 8 12 hours post dose (prior to the second dose) and 24, 36, 48, 72 and 108 hours post first dose.
Measured: Pre-dose up to 72-108 hours post first dose
Secondary outcomes (3)
Potential Infant Exposure
The daily infant dosage (total drug present in milk and potentially consumed by the infant per day) is calculated using the following formula:
Daily Infant Dosage (mg/day) = Σ (total drug concentration in each milk collection multiplied by the expressed milk volume in each milk collection)
Measured: Day 1 of dosing (0-24 hours post dose)
Participants With Treatment Emergent Adverse Events (TEAEs)
Any participant who experiences a Treatment Emergent Adverse Event (TEAE).
Measured: From the time of consent up to 108 hours post dose
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Adverse events are reported for all participants in the study.
Measured: From the time of consent up to 108 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start12 Jul 2023
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vulvovaginal CandidiasisStudies 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 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scynexis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06954493
- Sponsor's protocol ID
- SCY-078-121
- Status last verified
- Apr 2025
- First submitted
- 9 Jan 2024
- Last updated
- 8 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Open-Label Pharmacokinetic Study in Healthy Lactating Women After Two Oral Doses of Ibrexafungerp Administered on a Single Day
- ClinicalTrials.gov ID
- NCT06954493
- Acronym / sponsor ID
- SCY-078-121
- Keywords
- VVC, Thrush, BREXAFEMME, Candidiasis, Vaginal Yeast, Yeast Infection, Lactating, Fungal Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Scynexis, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Jul 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 1 May 2025 (actual)
- Results
- Posted 8 Aug 2025
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 pharmacokinetic evaluation of lactating women after receiving two doses of Ibrexafungerp. The study population included healthy lactating females who were at least 10 days postpartum with a fully established milk supply and were between the ages of 18 and 50 years at the time of screening
Detailed description
This was a Phase 1 study designed to evaluate the pharmacokinetics of ibrexafungerp after administration of two oral doses in lactating women to determine whether ibrexafungerp is excreted in breast milk, and if so, to characterize ibrexafungerp PK in the breast milk and plasma of lactating women.
Participants received a single day of twice daily (BID) 300-mg (2 x 150-mg) oral ibrexafungerp doses given 12 hours apart (Q12H). Participants received both doses on site. Participants were admitted to the clinic on Day 1 and discharged on Day 5, after the 108-hour procedures were completed.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label Treatment | Other | Drug: IbrexafungerpParticipants received a single day of twice daily (BID) 300-mg (2 x 150-mg) oral ibrexafungerp doses given 12 hours apart (Q12H) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- A healthy lactating woman aged 18 to 50 years, inclusive, at Screening
- At least 10-days postpartum after uncomplicated delivery with a full milk supply established. (There is no specific length of time postpartum)
- Actively breastfeeding or expressing breast milk
- willing to temporarily discontinue breast feeding their infant before the Day 1 morning dose through to 108 hours after the first dose (approximately 4.5 days) AND has the ability to pump breast milk and to provide a reserve for infant feeding, with acceptance of bottle feeding, prior to the study OR has decided to discontinue breastfeeding permanently but has not yet started weaning their infant with acceptance of bottle feeding and must have adequate milk supply
- Has a Body Mass Index (BMI) ≤34 kg/m2 at the screening visit. BMI is calculated by taking the participant's weight in kg and dividing by the participant's height in meters, squared.
Key exclusion criteria (13 listed)
- Is pregnant or unwilling or unable to comply with the lifestyle guidelines presented in the protocol during the study period and through the Post-Study visit
- Has evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric (including post-natal depression), neurologic, allergic disease (including drug allergies, but excluding untreated asymptomatic, seasonal allergies at time of dosing), or a history of neoplastic disease or any active cancer
- Is mentally or legally incapacitated
- Has a history of any illness or clinical findings that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the participant or infant by participation in the study
- Anticipates the use of prescription or non-prescription drugs that are strong CYP3A4 inducers, including vitamins, herbal and dietary supplements (including St. John's Wort) within 7 days of study drug administration (or 14 days if the drug is a potential enzyme inducer)
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 |
|---|---|---|
| IbrexafungerpIbrexafungerp Oral Tablet | Drug | Open Label Treatment |
Primary outcome
SCY-078 Breast Milk Concentrations.
Time frame: Pre-dose up to 108 hours post first dose
To determine the levels of SCY-078 in breast milk in ng/mL, starting pre-dose (Baseline) on Day 1 until 108 hours post first dose. Concentrations of SCY-078 in milk is measured pre-dose, and in milk collected at the following post-dose intervals: 0-2 hours, 2-4 hours, 4-8 hours, 8-12 hours, 12-18 hours, 18-24 hours, 24-36 hours, 36-48 hours, 48-72 hours and 72-108 hours.
SCY-078 Plasma Concentrations.
Time frame: Pre-dose up to 72-108 hours post first dose
To measure the levels of SCY-078 in plasma at pre-dose (0 hours), 2, 6, 8 12 hours post dose (prior to the second dose) and 24, 36, 48, 72 and 108 hours post first dose.
3 secondary outcomes
Potential Infant Exposure
Time frame: Day 1 of dosing (0-24 hours post dose)
Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: From the time of consent up to 108 hours post dose
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: From the time of consent up to 108 hours post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ibrexafungerp in people with Vulvovaginal Candidiasis and Candida Infection, run by Scynexis, Inc. 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 12 inclusion and 13 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: finished, as of the sponsor's last update on 8 Aug 2025. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SCY-078 Breast Milk Concentrations. (time frame: Pre-dose up to 108 hours post first dose). The study lists 2 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 8 Aug 2025.