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Trial Outcomes & Findings for Pharmacokinetic Study in Healthy Lactating Women Exposed to Ibrexafungerp (NCT NCT06954493)

NCT ID: NCT06954493

Last Updated: 2025-08-08

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

5 participants

Primary outcome timeframe

Pre-dose up to 108 hours post first dose

Results posted on

2025-08-08

Participant Flow

This is an open-label study.

Participant milestones

Participant milestones
Measure
Open Label Treatment
Participants will receive a single day of twice daily (BID) 300-mg (2 x 150-mg) oral ibrexafungerp doses given 12 hours apart (Q12H)
Overall Study
STARTED
5
Overall Study
COMPLETED
5
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacokinetic Study in Healthy Lactating Women Exposed to Ibrexafungerp

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Open Label Treatment
n=5 Participants
Participants will receive a single day of twice daily (BID) 300-mg (2 x 150-mg) oral ibrexafungerp doses given 12 hours apart (Q12H)
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
5 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Sex: Female, Male
Female
5 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
5 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=5 Participants
Race (NIH/OMB)
White
4 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Body Mass Index (BMI)
BMI 15 to <20
1 Participants
n=5 Participants
Body Mass Index (BMI)
BMI 20 to <25
2 Participants
n=5 Participants
Body Mass Index (BMI)
BMI 25 to <30
2 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Pre-dose up to 108 hours post first dose

Population: Pharmokinetic Population - all subjects that received ibrexafungerp (SCY-078) and that had at least one quantifiable Pk parameter.

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.

Outcome measures

Outcome measures
Measure
Open Label Treatment
n=5 Participants
Participants will receive a single day of twice daily (BID) 300-mg (2 x 150-mg) oral ibrexafungerp doses given 12 hours apart (Q12H)
SCY-078 Breast Milk Concentrations.
Pre-dose (Baseline)
0 ng/mL
Interval 0.0 to 0.0
SCY-078 Breast Milk Concentrations.
0-2 hours
37.64 ng/mL
Interval 9.8 to 49.8
SCY-078 Breast Milk Concentrations.
2-4 hours
72.22 ng/mL
Interval 32.1 to 94.1
SCY-078 Breast Milk Concentrations.
4-8 hours
43.85 ng/mL
Interval 36.8 to 84.1
SCY-078 Breast Milk Concentrations.
8-12 hours
25.62 ng/mL
Interval 20.1 to 73.9
SCY-078 Breast Milk Concentrations.
12-18 hours
44.9 ng/mL
Interval 29.8 to 66.6
SCY-078 Breast Milk Concentrations.
18-24 hours
51.87 ng/mL
Interval 42.3 to 65.3
SCY-078 Breast Milk Concentrations.
24-36 hours
43.48 ng/mL
Interval 22.7 to 60.6
SCY-078 Breast Milk Concentrations.
36-48 hours
13.8 ng/mL
Interval 12.6 to 42.0
SCY-078 Breast Milk Concentrations.
48-72 hours
8.04 ng/mL
Interval 7.0 to 22.2
SCY-078 Breast Milk Concentrations.
72-108 hours
0.00 ng/mL
Interval 0.0 to 11.0

PRIMARY outcome

Timeframe: Pre-dose up to 72-108 hours post first dose

Population: Pharmokinetic Population - all subjects that received ibrexafungerp (SCY-078) and that had at least one quantifiable Pk parameter.

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.

Outcome measures

Outcome measures
Measure
Open Label Treatment
n=5 Participants
Participants will receive a single day of twice daily (BID) 300-mg (2 x 150-mg) oral ibrexafungerp doses given 12 hours apart (Q12H)
SCY-078 Plasma Concentrations.
0 hours
0 ng/mL
Interval 0.0 to 0.0
SCY-078 Plasma Concentrations.
2 hours
321.25 ng/mL
Interval 256.7 to 556.4
SCY-078 Plasma Concentrations.
6 hours
437.81 ng/mL
Interval 202.5 to 530.7
SCY-078 Plasma Concentrations.
8 hours
370.76 ng/mL
Interval 216.3 to 432.1
SCY-078 Plasma Concentrations.
12 hours
315.17 ng/mL
Interval 153.8 to 333.0
SCY-078 Plasma Concentrations.
24 hours
400.06 ng/mL
Interval 265.3 to 481.4
SCY-078 Plasma Concentrations.
36 hours
295.15 ng/mL
Interval 137.8 to 317.1
SCY-078 Plasma Concentrations.
48 hours
145.12 ng/mL
Interval 72.1 to 195.1
SCY-078 Plasma Concentrations.
72 hours
59.89 ng/mL
Interval 38.7 to 95.2
SCY-078 Plasma Concentrations.
108 hours
21.56 ng/mL
Interval 11.4 to 36.9

SECONDARY outcome

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

Population: Pharmokinetic Population - all subjects that received ibrexafungerp (SCY-078) and that had at least one quantifiable Pk parameter.

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)

Outcome measures

Outcome measures
Measure
Open Label Treatment
n=5 Participants
Participants will receive a single day of twice daily (BID) 300-mg (2 x 150-mg) oral ibrexafungerp doses given 12 hours apart (Q12H)
Potential Infant Exposure
0.0303 mg/day
Interval 0.006 to 0.156

SECONDARY outcome

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

Population: Safety Population - All participants who were enrolled in the study and received at least a partial tablet of ibrexafungerp.

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

Outcome measures

Outcome measures
Measure
Open Label Treatment
n=5 Participants
Participants will receive a single day of twice daily (BID) 300-mg (2 x 150-mg) oral ibrexafungerp doses given 12 hours apart (Q12H)
Participants With Treatment Emergent Adverse Events (TEAEs)
1 Participants

SECONDARY outcome

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

Population: Safety Population - All participants who were enrolled in the study and received at least a partial tablet of ibrexafungerp.

Adverse events are reported for all participants in the study.

Outcome measures

Outcome measures
Measure
Open Label Treatment
n=5 Participants
Participants will receive a single day of twice daily (BID) 300-mg (2 x 150-mg) oral ibrexafungerp doses given 12 hours apart (Q12H)
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Gastrointestinal disorders - Soft Stool
1 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
No TEAEs
4 Participants

Adverse Events

Open Label Treatment

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Open Label Treatment
n=5 participants at risk
Participants will receive a single day of twice daily (BID) 300-mg (2 x 150-mg) oral ibrexafungerp doses given 12 hours apart (Q12H)
Gastrointestinal disorders
Faeces soft / SOFT STOOL
20.0%
1/5 • Number of events 1 • Adverse Events were collected from the time of consent through the End of Study Visit (approximately 5 days)

Additional Information

David Angulo, MD

SCYNEXIS, Inc

Phone: (201) 884 - 5471

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place