ArticleInfectious diseases and therapy2022
Study on Pharmacokinetic Interactions Between HS-10234 and Emtricitabine in Healthy Subjects: An Open-Label, Two-Sequence, Self-Controlled Phase I Trial.
Article in Infectious diseases and therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04477096 (Study on the Drug Interaction of HS-10234 and Emtricitabine in Healthy Subjects), which is not on this map. Cited by 1 paper.
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Study on the Drug Interaction of HS-10234 and Emtricitabine in Healthy Subjects
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1 citing paper in PubMed, 3 citations in OpenAlex.
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12 authors at 2 institutions in 1 country.
Funding
Abstract
introductionHS-10234, a novel prodrug of tenofovir (TFV), functions by inhibiting nucleotide reverse transcriptase against retroviral infections including hepatitis B virus and human immunodeficiency virus (HIV). As it is a possible substitute for TFV co-administration with emtricitabine, determining the drug-drug interactions (DDI) between HS-10234 and emtricitabine therapy will be helpful for researchers to design and conduct future phase II/III studies and merits careful examination in the era of evolving new combination antiretroviral therapy regimens.
methodsWe conducted an open-label, two-sequence, two-period, self-controlled phase I trial that enrolled 36 healthy volunteers randomized into two groups (group 1 and group 2). Eighteen subjects in group 1 were orally administered HS-10234 at a 25-mg daily dose for 7 days during period 1 (D1-D7) followed by co-administration of emtricitabine at a 200-mg dose once daily (QD) for 7 additional days during period 2 (D8-D14). Participants in group 2 were orally administered emtricitabine 200 mg QD for 7 days during period 1 (D1-D7) and then co-administered HS-10234 25 mg QD for 7 additional days during period 2 (D8-D14). Pharmacokinetics (PK) of HS-10234 and emtricitabine were characterized when administered alone and in combination. The concentrations of HS-10234 and its metabolites TFV and emtricitabine were determined using high performance liquid chromatography-mass spectrometry (HPLC-MS)/MS. Peripheral blood monocyte cells (PBMCs) were isolated for detection of intracellular concentrations of HS-10234's active metabolite, intracellular tenofovir diphosphate (TFV-DP) pre-dose and 2, 4, 8, 12 and 24 h post-dose on D7 and D14 in group 1. WinNonlin software was used to calculate PK parameters.
resultsAfter multiple-dose administration of HS-10234 with emtricitabine, the AUC
conclusionsAlthough a slightly increased steady-state PK exposure of HS-10234 and TFV-DP was observed with co-administration of oral HS-10234 with emtricitabine, these changes were not considered clinically relevant. Thus, dose adjustments are not recommended for HS-10234 combination with emtricitabine.
trial registrationNCT04477096, July 20, 2020.
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