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NCT07758608
Renal Impairment Pharmacokinetics (PK) Trial of Afabicin
Conditions: Renal Impairment
Sex: All
Ages: 18 Years – 85 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 60
Sponsor: Debiopharm International SA
Location: Charite Research Organisation Berlin
Summary
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.
Eligibility Criteria
Inclusion Criteria:
1. Signed and dated written informed consent obtained before undertaking any trial-specific procedures.
2. Body Mass Index (BMI): 18.5 to 35.0 kilograms per square meter (kg/m\^2), inclusive, at screening.
3. Nonsmoker (confirmed by urine cotinine \
Source: ClinicalTrials.gov (NCT07758608). StuddyBuddy aggregates publicly available trial information.
