Status and phase
Conditions
Treatments
About
This will be an open-label, randomized, 2-treatment, 2-period, crossover single-dose study in approximately 134 healthy adult participants. Participants will be randomized into 2 sequences of treatment as described in the following table of Intervention Groups and Duration.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Lack of adequate hepatic reserve, defined by AST/SGOT or ALT/SGPT >= 1.5 × ULN of the reference laboratory; TBili >= 1.5 × ULN; participants with a history of Gilbert's syndrome may have a direct bilirubin measured and would be eligible for this study provided the direct bilirubin is <= ULN.
Lack of renal reserve, defined by serum creatinine of >= 1.2 × ULN for reference laboratory or eGFR of <= 80 mL/minute; or known history of glomerulonephritis.
Primary purpose
Allocation
Interventional model
Masking
141 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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