The investigators believe that boceprevir's drug concentrations will be reduced when administered in combination with etravirine. The investigators believe that etravirine's drug concentrations will be increased when administered in combination with boceprevir. Additionally, the investigators believe that boceprevir and etravirine are safe when administered alone or in combination.
To investigate the potential for drug interactions between boceprevir and etravirine, participants will receive each drug alone and the drugs in combination for 11-14 days. The pharmacokinetics of boceprevir and etravirine when given in combination vs. alone will be compared.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
26
boceprevir tablets 800 mg, every 8 hours x 11-14 days. etravirine tablets 200 mg, every 12 hours x 11-14 days.
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Boceprevir AUC Pharmacokinetics
Determine boceprevir area-under-the concentration time curve (AUC) when administered alone.
Time frame: Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14
Boceprevir Cmax Pharmacokinetics
Determine the Cmax of boceprevir when administered alone.
Time frame: Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14
Boceprevir C8 Pharmacokinetics
Determine boceprevir 8 hour concentration when administered alone.
Time frame: Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14
Etravirine AUC Pharmacokinetics
Determine etravirine area under the concentration vs. time curve (AUC)when administered alone.
Time frame: Pre-dose and, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post dose on day 11-14
Etravirine Cmax Pharmacokinetics
Determine etravirine Cmax when administered alone
Time frame: Pre-dose and, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post dose on day 11-14
Etravirine Cmin Pharmacokinetics
Determine etravirine Cmin when administered alone
Time frame: Pre-dose and, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post dose on day 11-14
Boceprevir AUC Pharmacokinetics Coadministered With Etravirine
Determine boceprevir AUC when coadministered with etravirine. \[Ratio = boceprevir administered with etravirine/ boceprevir alone\]
Time frame: Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14
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Boceprevir Cmax Pharmacokinetics Coadministered With Etravirine
Determine boceprevir Cmax when coadministered with etravirine. \[Ratio = boceprevir administered with etravirine / boceprevir alone\]
Time frame: Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14
Boceprevir C8 Pharmacokinetics Coadministered With Etravirine
Determine boceprevir 8 hour concentration when coadministered with etravirine. \[Ratio = boceprevir administered with etravirine / boceprevir administered alone\]
Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14
Etravirine AUC Pharmacokinetics Coadministered With Boceprevir
Determine etravirine AUC when coadministered with boceprevir. \[Ratio = Etravirine administered with bocepreivr / etravirine administered alone\]
Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours Post-dose on day 11-14
Etravirine Cmax Pharmacokinetics Coadministered With Boceprevir
Determine etravirine Cmax when coadministered with boceprevir. \[Ratio = etravirine administered with boceprevir / etravirine administered alone\]
Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose on day 11-14
Etravirine Cmin Pharmacokinetics Coadministered With Boceprevir
Determine etravirine Cmin when coadministered with boceprevir. \[Ratio = etravirine administered with boceprevir / etravirine administered alone\]
Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose on day 11-14