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Phase I, single-center, open-label, two-sequence, two-period self-controlled study to assess the DDI of HS-10234 and emtricitabine as well as the PK and safety profiles of HS-10234 and emtricitabine in healthy adults. 36 subjects were recruited and randomized into two equal groups (group 1 and group 2). Participants in group 1 were orally administered HS-10234 at a 25-mg&8201;daily dose for 7 days during period 1 (day 17) followed by co-administered with emtricitabine at a 200-mg dose once daily (QD) for 7 additional days during period 2 (day 814). Participants in group 2 were orally administered emtricitabine 200 mg&8201;QD for 7 days during period 1 (day 17) and then co-administered HS-10234 25 mg&8201;QD for 7 additional days during period 2 (day 814). Pharmacokinetic responses of HS-10234, tenofovir (TFV), and active metabolite tenofovir diphosphate (TFV-DP) were measured.
Upon co-administration with emtricitabine in group 1, the mean Cmax of HS-10234 and tenofovir-diphosphate (TFV-DP) increased by approximately 29 and 26 respectively, and the mean AUC0tau of HS-10234 and TFV-DP increased by approximately 33 and 44 respectively, while the mean TFV Cmax and AUC0tau were just increased by 8 and 14, respectively. In group 2, co-administration with HS-10234 resulted in slightly increased exposure of emtricitabine in plasma, and emtricitabines Cmax and AUC0tau were only 12 and 8 higher than with administration of emtricitabine alone.
Although 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.
Luo, Y, Chen, W, Yang, G, Zou, C, Huang, J, Kuang, Y, Shen, K, Zhang, B, Yang, S, Xiang, H, Li, Z, Pei, Q. Study on pharmacokinetic interactions between hs-10234 and emtricitabine in healthy subjects: an open-label, two-sequence, self-controlled phase i trial. Infectious Diseases And Therapy. 2022; 1: 175-186.