A Randomized, Open-label, Single-dose, Cross-over Phase 1 Study to Evaluate the Effect of Food on Pharmacokinetic Characteristics and Safety of CKD-379 in Healthy Adult Volunteers

A clinical trial to evaluate the food effect of CKD-379

开始日期2024-11-05

申办/合作机构

Chong Kun Dang Pharmaceutical Corp.

NCT06204107 / Completed临床1期

A Randomized, Open-label, Single Dose, Crossover, Phase Ⅰ Trial to Evaluate the Food Effect on Pharmacokinetic Profiles and Safety of CKD-379 in Healthy Volunteers

This is a randomized, open-label, single dose, crossover, phase Ⅰ trial to evaluate the food effect on pharmacokinetic profiles and safety of CKD-379 in healthy volunteers

开始日期2023-11-21

申办/合作机构

Chong Kun Dang Pharmaceutical Corp.

NCT05952219 / Active, not recruiting临床1期

A Randomized, Open-label, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-379 in Healthy Volunteers Under Fed Conditions

A study to compare the pharmacokinetics and safety between CKD-379 and D759, D745, D029, D150 combination

开始日期2023-06-02

申办/合作机构

Chong Kun Dang Pharmaceutical Corp.

100 项与 DPP-4 x SGLT2 x PRKAB1 相关的临床结果

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100 项与 DPP-4 x SGLT2 x PRKAB1 相关的转化医学

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0 项与 DPP-4 x SGLT2 x PRKAB1 相关的专利（医药）

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项与 DPP-4 x SGLT2 x PRKAB1 相关的文献（医药）

Cell & Bioscience

Association of glucose-lowering drug target and risk of gastrointestinal cancer: a mendelian randomization study

Article

作者: Chen, Yaqing ; Yang, Yi ; Zeng, Hao ; Jin, Ruxue ; Chen, Bo ; Zhou, Junxi ; Wang, Jingxian ; Wang, Juejin ; Wang, Hongli ; Bo, Zhiyuan ; Wang, Yi ; Wang, Yurong ; Chen, Gang ; Zheng, Chongming ; Su, Qing

AbstractBackground & AimsGlucose-lowering drug is associated with various cancers, but the causality with gastrointestinal cancer risk is rarely reported. We aimed to explore the causality between them in this Mendelian randomization (MR) study.MethodsTwo-sample MR, summary-data-based (SMR), mediation MR, and colocalization analyses was employed. Ten glucose-lowering drug targets (PPARG, DPP4, GLP1R, INSR, SLC5A2, ABCC8, KCNJ11, ETFDH, GPD2, PRKAB1) and seven types of gastrointestinal cancer (anal carcinoma, cardia cancer, gastric cancer, hepatocellular carcinoma (HCC), intrahepatic cholangiocarcinoma (ICC), pancreatic cancer, rectum cancer) were included. Patients with gastrointestinal cancers from six different large GWAS databases, including the UK Biobank and Finnish cohorts were incorporated, for discovery and external validation. Meta-analysis was employed to integrate the results from both discovery and validation cohorts, thereby ensuring the reliability of findings.ResultsABCC8/KCNJ11 were associated with pancreatic cancer risk in both two-sample MR (odds ratio (OR): 15.058, per standard deviation unit (SD) change of glucose-lowering durg target perturbation equivalent to 1 SD unit of HbA1c lowering; 95% confidence interval (95% CI): 3.824–59.295; P-value = 0.0001) and SMR (OR: 1.142; 95% CI: 1.013–1.287; P-value = 0.030) analyses. The mediation effect of body mass index (OR: 0.938; 95% CI: 0.884–0.995; proportion of mediation effect: 3.001%; P-value = 0.033) on ABCC8/KCNJ11 and pancreatic cancer was uncovered. Strong connections of DPP4 with anal carcinoma (OR: 0.123; 95% CI: 0.020–0.745; P-value = 0.023) and ICC (OR: 7.733; 95% CI: 1.743–34.310; P-value = 0.007) were detected. PPARG was associated with anal carcinoma (OR: 12.909; 95% CI: 3.217–51.795; P-value = 0.0003), HCC (OR: 36.507; 95% CI: 8.929-149.259; P-value < 0.0001), and pancreatic cancer (OR: 0.110; 95% CI: 0.071–0.172; P-value < 0.0001). SLC5A2 was connected with pancreatic cancer (OR: 8.096; 95% CI: 3.476–18.857; P-value < 0.0001). Weak evidence indicated the connections of GLP1R, GPD2, and PRKAB1 with anal carcinoma, cardia cancer, ICC, and rectum cancer. In addition, the corresponding results were consistently validated in both the validation cohorts and the integrated outcomes.ConclusionsSome glucose-lowering drugs were associated with gastrointestinal cancer risk, which might provide new ideas for gastrointestinal cancer treatment.