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- W4200504628 abstract "Background: Molnupiravir, an orally administered prodrug of the broadly active, direct-acting antiviral, ribonucleoside analogue β-d-N4-hydroxycytidine (NHC) is a promising COVID-19 drug candidate. We characterised the pharmacokinetics of NHC in saliva, nasal secretions and tears of patients enrolled in the phase I AGILE trial ( NCT04746183 ) to understand its potential in preventing infection and transmission. Methods: Patients with PCR-confirmed SARS-CoV-2 infection, within 5 days of symptom onset with mild-to-moderate disease were randomised to oral molnupiravir 300, 600 or 800 mg twice daily or placebo. Plasma and non-plasma (saliva, nasal secretions and tears) samples were collected at pre-dose, 0.5, 1, 2, and 4 hours post-dose on study days 1 and 5 and molnupiravir and NHC measured by LC/MS with a lower limit of quantification of 2.5 ng/mL in all matrices. Pharmacokinetic parameters were determined by noncompartmental methods and non-plasma:plasma ratios (R NP:P ; based on AUC 0-4 ) calculated. Results: Twelve participants (n=4 per dosing arm; 75% female) completed the study. NHC T max ranged between 1.00-4.00 hours for saliva (n=21) and nasal swabs (n=22) and 0.50-4.00 hours (n=17) for tears compared to 1.00-2.00 hours for plasma (n=19). Median (range) saliva R NP:P pooled across doses was 0.03 (0.01-0.11); n=16. R NP:P for nasal secretions and tears were 0.21 (0.05-0.73); n=17 and 0.22 (0.09-1.05); n=12, respectively. Non-plasma and plasma concentrations were significantly correlated ( p <0.0001). Conclusion: These data provide encouraging information regarding the distribution of NHC at sites of viral transmission and have important implications for prophylactic coverage." @default.
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- W4200504628 date "2021-12-07" @default.
- W4200504628 modified "2023-10-17" @default.
- W4200504628 title "Pharmacokinetics of β-d-N4-hydroxycytidine, the active metabolite of prodrug molnupiravir, in non-plasma compartments of patients with SARS-CoV-2 infection" @default.
- W4200504628 doi "https://doi.org/10.1101/2021.12.06.21267342" @default.
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