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Renal Impairment Pharmacokinetics (PK) Trial of Afabicin

StatusNot Yet Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Minor Start date: Aug 2026 to Sep 2026
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 2 of 7 entries
  2. Minor Study sites: 0 to 1v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The primary purpose of this study is to assess the effect of renal impairment on the PK of afabicin desphosphono after a single oral 80 milligrams (mg) or intravenous (IV) 55 mg dose of afabicin.
Trial Details
NCT Number NCT07758608
Lead Sponsor Debiopharm International SA
Conditions
(from sponsor)
Renal Impairment
Related terms Renal Insufficiency
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov