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Pharmacokinetic Study in Healthy Lactating Women Exposed to Ibrexafungerp

NCT06954493 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2025-08-08

Study results available
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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

Conditions

  • Vulvovaginal Candidiasis
  • Candida Infection
  • Vaginal Candidiasis

Interventions

DRUG

Ibrexafungerp

Ibrexafungerp Oral Tablet

Sponsors & Collaborators

  • Scynexis, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-12
Primary Completion
2023-11-01
Completion
2023-11-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06954493 on ClinicalTrials.gov