Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06954493 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic Study in Healthy Lactating Women Exposed to Ibrexafungerp
A Phase 1 study, sponsored by Scynexis.
- Completed
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT06954493: Completed Phase 1 study, sponsored by Scynexis.
NCT06954493 is a Phase 1 study that has completed, run by Scynexis. The registered enrollment target is 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06954493, a Phase 1 study, has completed, sponsored by Scynexis.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
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
Primary Outcome
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.
Interventions
- DRUG Ibrexafungerp
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2023-07-12 |
| Est. Completion | 2023-11-01 |
| Phase | Phase 1 |
What the finished NCT06954493 record still lists
NCT06954493 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which Ibrexafungerp is the first listed.
NCT06954493 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06954493 about?
NCT06954493 is a clinical study titled "Pharmacokinetic Study in Healthy Lactating Women Exposed to Ibrexafungerp". 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
What is the current status of trial NCT06954493?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2023-07-12. Estimated completion is 2023-11-01.
What interventions are being tested in trial NCT06954493?
The interventions under investigation include: Ibrexafungerp (DRUG).
Who is sponsoring clinical trial NCT06954493?
This trial is sponsored by Scynexis, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06954493's enrollment target sits among peer trials
5 1989th of 2000 higher than 6 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI