ArticleFrontiers in pharmacology2026
A phase I clinical trial evaluating the effect of food on the pharmacokinetics of TSL-1502, a glucuronide prodrug of a novel oral poly (ADP-ribose) polymerase inhibitor, in healthy Chinese subjects.
Article in Frontiers in pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Objective: Poly (ADP-ribose) polymerase (PARP) inhibitors, based on synthetic lethality, have demonstrated significant efficacy in tumors with homologous recombination repair (HRR) deficiencies but are limited by severe hematological toxicities. TSL-1502 is a glucuronide prodrug of a novel oral small-molecule PARP inhibitor that releases its active metabolite, TSL-1502M, specifically in tumor tissues. This phase I study aimed to evaluate the impact of food on the pharmacokinetics and safety of TSL-1502, guiding its clinical use. Methods: Twenty healthy Chinese subjects were randomized into two groups (A and B, n = 10 each). In a two-period crossover design, participants received a single 200 mg oral dose of TSL-1502 under fasting or fed conditions. Plasma concentrations of TSL-1502 and TSL-1502M were measured using liquid chromatography-tandem mass spectrometry, and safety was assessed throughout. Results: Food delayed the absorption of TSL-1502 but did not significantly affect its elimination half-life. The least-squares geometric mean ratios (fed/fasted) for AUC Conclusion: Food delayed the absorption of TSL-1502 and substantially reduced its peak plasma concentration (Cmax), while AUC was moderately affected. TSL-1502 was well tolerated, and food did not affect its safety profile. These results suggest that TSL-1502 can be administered with or without food.
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