ArticleClinical drug investigation2026
Pharmacokinetic Drug Interaction Studies of Limnetrelvir with Midazolam and Itraconazole in Healthy Participants.
Article in Clinical drug investigation, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Not yet cited in PubMed.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 1 First in Human, Single and Multiple Ascending Dose and Food Effect and Drug-Drug Interaction in Healthy Subjects to Evaluate the Safety, Tolerability and Assessment of Pharmacokinetics of ABBV-903
A Phase 1 Open-Label Drug-Drug Interaction Study Between ABBV-903 and Midazolam
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12 authors.
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Abstract
BACKGROUND AND
objectivesLimnetrelvir is an oral inhibitor of the SARS-CoV-2 main protease (Mpro) and was developed with the aim of achieving broad-spectrum efficacy against SARS-CoV-2 and emerging variants. The aim of this work was to evaluate potential CYP3A4 drug-drug interactions (DDIs) of limnetrelvir.
methodsIn two phase 1, open-label studies, limnetrelvir was evaluated for DDIs with midazolam (Study 1), a CYP3A4 substrate, and itraconazole (Study 2), a strong CYP3A4 inhibitor. Study 1 (N = 24) consisted of two parts (Studies 1A and 1B), each with two periods (Periods 1 and 2), and Study 2 (N = 12) consisted of one part with two periods. In Study 1A, 12 healthy adult participants received midazolam (1 mg) on Period 1 Day 1 and Period 2 Day 10 and limnetrelvir 400 mg once daily (QD) on Period 2 Days 1-10. In Study 1B, an additional 12 healthy adult participants received midazolam (1 mg) on Period 1 Day 1 and Period 2 Day 5 and limnetrelvir 200 mg QD on Period 2 Days 1-5. In Study 2, 12 participants received limnetrelvir (50 mg) and itraconazole (200 mg twice daily on Day 1 and QD on Days 2 to 6 in Period 2), with limnetrelvir administered as a single dose on Period 1 Day 1 and Period 2 Day 4. All study drugs were administered orally. Serial blood samples were collected and analyzed for drug concentrations. Pharmacokinetic parameters were determined with noncompartmental methods.
resultsCoadministration of limnetrelvir increased the maximum concentration (C
conclusionsLimnetrelvir was found to be a moderate CYP3A4 inhibitor and substrate, suggesting that dosing adjustment or careful monitoring may be necessary when coadministered with medications highly metabolized by CYP3A4 or with strong CYP3A4 inhibitors to ensure safe and effective treatment. TRIAL REGISTRATION NUMBER (TRN): NCT05691699, NCT05895266. Date of registration: 01/09/2023, 05/31/2023.
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