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CompletedNCT06954493Updated Aug 8, 2025Results posted

Pharmacokinetic Study in Healthy Lactating Women Exposed to Ibrexafungerp

A Phase 1 interventional study of Ibrexafungerp in Vulvovaginal Candidiasis, Candida Infection and Vaginal Candidiasis, sponsored by Scynexis, Inc.. Completed at 1 site in United States. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-08.

Sponsored by Scynexis, Inc. · Phase 1, Interventional, and Other

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Jul 2023, registered Jan 2024).
Phase
Phase 1
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Vulvovaginal Candidiasis
  • Candida Infection
  • Vaginal Candidiasis

Keywords

  • VVC
  • Thrush
  • BREXAFEMME
  • Candidiasis
  • Vaginal Yeast
  • Yeast Infection
  • Lactating
  • Fungal Disease
  • Fungal Infection
03

In context

Candidiasis, Vulvovaginal

109 studies on the registry are indexed under Candidiasis, Vulvovaginal; 14 are open to participants now.

This study's enrollment of 5 is below the median of 126 across 91 interventional studies indexed under Candidiasis, Vulvovaginal.

Browse Candidiasis, Vulvovaginal studies →

Lead sponsor

Scynexis, Inc. is the lead sponsor of 18 studies on the registry; none are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 10 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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.

Inclusion criteria

  • 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 (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
  • 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 abnormality on (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
  • 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

Exclusion criteria

Exclusion Criteria:

  • 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 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 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
  • 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 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 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
Terms in these criteria, in plain language(7)

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.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

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.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

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.

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.

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.

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.

05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (actual)

Study arms

  • Other
    Open Label Treatment

    Participants received a single day of twice daily (BID) 300-mg (2 x 150-mg) oral ibrexafungerp doses given 12 hours apart (Q12H)

    Drug: Ibrexafungerp

Interventions

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Pre-dose up to 108 hours post first dose

  2. 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.

    Time frame: Pre-dose up to 72-108 hours post first dose

Secondary outcomes

  1. 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)

    Time frame: Day 1 of dosing (0-24 hours post dose)

  2. Participants With Treatment Emergent Adverse Events (TEAEs)

    Any participant who experiences a Treatment Emergent Adverse Event (TEAE).

    Time frame: From the time of consent up to 108 hours post dose

  3. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    Adverse events are reported for all participants in the study.

    Time frame: From the time of consent up to 108 hours post-dose

07

Results

Posted Aug 8, 2025

Participant flow

Participant flow — Overall Study
MilestoneOpen Label Treatment
Started5
Completed5
Not completed0

Outcome measures

PrimarySCY-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.

Time frame:
Pre-dose up to 108 hours post first dose
Reported as:
Median · ng/mL
SCY-078 Breast Milk Concentrations.
ng/mLOpen Label Treatment
Pre-dose (Baseline)0 (0 to 0)
0-2 hours37.64 (9.8 to 49.8)
2-4 hours72.22 (32.1 to 94.1)
4-8 hours43.85 (36.8 to 84.1)
8-12 hours25.62 (20.1 to 73.9)
12-18 hours44.9 (29.8 to 66.6)
18-24 hours51.87 (42.3 to 65.3)
24-36 hours43.48 (22.7 to 60.6)
36-48 hours13.8 (12.6 to 42.0)
48-72 hours8.04 (7.0 to 22.2)
72-108 hours0.00 (0.0 to 11.0)
PrimarySCY-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.

Time frame:
Pre-dose up to 72-108 hours post first dose
Reported as:
Median · ng/mL
SCY-078 Plasma Concentrations.
ng/mLOpen Label Treatment
0 hours0 (0 to 0)
2 hours321.25 (256.7 to 556.4)
6 hours437.81 (202.5 to 530.7)
8 hours370.76 (216.3 to 432.1)
12 hours315.17 (153.8 to 333.0)
24 hours400.06 (265.3 to 481.4)
36 hours295.15 (137.8 to 317.1)
48 hours145.12 (72.1 to 195.1)
72 hours59.89 (38.7 to 95.2)
108 hours21.56 (11.4 to 36.9)
SecondaryPotential 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)

Time frame:
Day 1 of dosing (0-24 hours post dose)
Reported as:
Median · mg/day
Potential Infant Exposure
mg/dayOpen Label Treatment
Potential Infant Exposure0.0303 (0.006 to 0.156)
SecondaryParticipants With Treatment Emergent Adverse Events (TEAEs)

Any participant who experiences a Treatment Emergent Adverse Event (TEAE).

Time frame:
From the time of consent up to 108 hours post dose
Reported as:
Count of participants · Participants
Participants With Treatment Emergent Adverse Events (TEAEs)
ParticipantsOpen Label Treatment
Participants With Treatment Emergent Adverse Events (TEAEs)1
SecondaryNumber of Participants With Treatment Emergent Adverse Events (TEAEs)

Adverse events are reported for all participants in the study.

Time frame:
From the time of consent up to 108 hours post-dose
Reported as:
Count of participants · Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
ParticipantsOpen Label Treatment
Gastrointestinal disorders - Soft Stool1
No TEAEs4

Adverse events

Collected over Adverse Events were collected from the time of consent through the End of Study Visit (approximately 5 days). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Open Label Treatment0/5 (0%)0/5 (0%)1/5 (20%)
Most frequent other events
Most frequent other events
EventOpen Label Treatment
Faeces soft / SOFT STOOLGastrointestinal disorders1/5

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Open Label Treatment
<=18 years0
Between 18 and 65 years5
>=65 years0
Sex: Female, Male
Sex: Female, Male(Participants)Open Label Treatment
Female5
Male0
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Open Label Treatment
Hispanic or Latino0
Not Hispanic or Latino5
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Open Label Treatment
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American1
White4
More than one race0
Unknown or Not Reported0
Body Mass Index (BMI)
Body Mass Index (BMI)(Participants)Open Label Treatment
BMI 15 to <201
BMI 20 to <252
BMI 25 to <302
08

Study locations

1 site
  • Woodland Research Northwest (WRN)
    Rogers, Arkansas 72758, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2023 to primary completion in Nov 2023, 3 months.

Results were first posted in Aug 2025, 1 year 9 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 9, 2024
First posted
May 1, 2025
StartActual
Jul 12, 2023
Primary completionActual
Nov 1, 2023
CompletionActual
Nov 1, 2023
Results first posted
Aug 8, 2025
Last update
Aug 8, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT06954493
Lead sponsor
Scynexis, Inc.
Responsible party
Sponsor
First posted
May 1, 2025
Start date
Jul 12, 2023
Primary completion
Nov 1, 2023
Completion
Nov 1, 2023
Results posted
Aug 8, 2025
Last update
Aug 8, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Ibrexafungerp

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