Single Dose Glumetinib in Healthy Chinese Male Subjects

Healthy Volunteers Clinical Trial

Official title: A Clinical Study to Evaluate Food Effect on Pharmacokinetics and Safety After Single Dose Glumetinib in Healthy Chinese Male Subjects

Status Completed

Clinical Trial 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.

Clinical Trial Description

Approximately 18 healthy adult male subjects are expected to be enrolled randomly into 6 meal sequences, with 3 subjects per sequence. Each subject receive Glumetinib given under fasting condition, after a high-fat meal, or following a low-fat meal, respectively, in three periods.Subjects enrolled in each period received 300 mg Glumetinib once and PK blood samples are collected after dosing once daily for 7 days.To clarify the occurrence of AEs, subjects should complete safety examinations on Day 8 of each period. Subjects with AE are followed up before the next period of administration. Before the next administration, subjects with no AE or ongoing AE with Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 enter into the next period and continued receiving dosing; subjects reported AEs with CTCAE Grade higher than 1 are discontinued from the study and are followed up by investigator until the AE disappeared, stabilized, return to baseline or lost to follow-up (whichever occurred first) ;

Related Conditions & MeSH terms

• Healthy Volunteers

• NCT number: NCT05507294
• Study type: Interventional
• Source: Haihe Biopharma Co., Ltd.
• Status: Completed
• Phase: Phase 1
• Start date: March 2, 2021
• Completion date: September 30, 2021