drugset / Trial / NCT05507294

Single Dose Glumetinib in Healthy Chinese Male Subjects

NCT05507294

Phase 1 Completed 18 enrolled Haihe Biopharma Co., Ltd.
RandomizedCrossoverOpen-labelHealth-services research

Summary

This is a phase I, single-center, randomized, open-label, single-dose, three-period (fasting, high-fat meal, low-fat meal) crossover clinical study to investigate the food effect on PK of the recommended phase II dose (RP2D) of 300 mg Glumetinib, based on the previous clinical studies of Glumetinib monotherapy.

Timeline

Start
2021-03-02
Primary completion
2021-05-21
Completion
2021-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Gumarontinib Small molecule 300 mg Oral

Indications

No indication recorded.