A Study to Evaluate Doravirine Pharmacokinetics When Coadministered With Acid-Reducing Agents

Journal of Clinical Pharmacology
Sauzanne G KhaliliehMarian Iwamoto

Abstract

Doravirine is a novel non-nucleoside reverse transcriptase inhibitor indicated for the treatment of human immunodeficiency virus type 1 infection. Because of potential concomitant administration with acid-reducing agents, a drug-interaction trial was conducted to evaluate the potential impact of these types of medications on doravirine pharmacokinetics. In an open-label, 3-period, fixed-sequence trial, healthy adult participants received the following: period 1, a single dose of doravirine 100 mg; period 2, coadministration of a single dose of doravirine 100 mg and an antacid (1600 mg aluminum hydroxide, 1600 mg magnesium hydroxide, and 160 mg simethicone); period 3, 40 mg pantoprazole once daily on days 1-5 coadministered with a single dose of doravirine 100 mg on day 5. There was a minimum 10-day washout between periods. Plasma samples for pharmacokinetic evaluation were collected, and safety was assessed. Fourteen participants (8 male, 6 female) were enrolled, and 13 completed the trial. Geometric mean ratios (90% confidence intervals) for doravirine AUC0-inf , Cmax , and C24 for doravirine + antacid/doravirine were 1.01 (0.92-1.11), 0.86 (0.74-1.01), and 1.03 (0.94-1.12), respectively, and for doravirine + pantoprazole/dora...Continue Reading

References

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Feb 7, 2012·Proceedings of the National Academy of Sciences of the United States of America·Arpita AgrawalSeth M Cohen
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Mar 21, 2018·Xenobiotica; the Fate of Foreign Compounds in Biological Systems·Rosa I SanchezSauzanne G Khalilieh

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Citations

Aug 17, 2019·The Annals of Pharmacotherapy·Sarah R BlevinsDavid B Cluck
Jun 6, 2020·Journal of Clinical Pharmacy and Therapeutics·Ka Lai YeeMarian Iwamoto
Aug 8, 2019·Clinical Pharmacokinetics·Alison BoyleSaye Khoo
Feb 27, 2021·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Princy KumarUNKNOWN DRIVE-SHIFT Study Group

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