This study will evaluate the effect of severe renal impairment on the pharmacokinetics of doravirine.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Following an overnight fast, a single coated tablet of 100 mg doravirine will be administered orally
Area Under the Plasma Concentration Versus Time Curve From 0 Hours to Infinity (AUC0-∞) of Doravirine
Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method.
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 12, 24, 48, 72 hours post-dose for all participants; and 96 hours post-dose for participants with severe renal impairment
Plasma Concentration of Doravirine at 24 Hours Postdose (C24)
Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method.
Time frame: 24 hours postdose
Maximum Observed Plasma Concentration (Cmax) of Doravirine
Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method.
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 12, 24, 48, 72 hours post-dose for all participants; and 96 hours post-dose for participants with severe renal impairment
Area Under the Plasma Concentration Versus Time Curve From 0 Hours to the Time of Last Quantifiable Sample of Doravirine (AUC 0-last)
Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method.
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 12, 24, 48, 72 hours post-dose for all participants; and 96 hours post-dose for participants with severe renal impairment
Time to Maximum Observed Plasma Concentration (Tmax) of Doravirine
Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method.
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 12, 24, 48, 72 hours post-dose for all participants; and 96 hours post-dose for participants with severe renal impairment
Apparent Terminal Half-life (t1/2) of Plasma Doravirine
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Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method.
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 12, 24, 48, 72 hours post-dose for all participants; and 96 hours post-dose for participants with severe renal impairment
Apparent Clearance of Plasma Doravirine After Extravascular Administration (CL/F)
Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method.
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 12, 24, 48, 72 hours post-dose for all participants; and 96 hours post-dose for participants with severe renal impairment
Apparent Volume of Distribution of Plasma Doravirine During the Terminal Phase (Vz/F)
Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method.
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 12, 24, 48, 72 hours post-dose for all participants; and 96 hours post-dose for participants with severe renal impairment