NCT05507294

Single Dose Glumetinib in Healthy Chinese Male Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Haihe Biopharma Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed 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)

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Glumetinib	Fasting: Subjects are fasted overnight (at least 10 hours before administration) and receive Glumetinib tablets with 240 mL warm water the next morning. Fed (high-fat meal/low-fat meal): Following an overnight fast for at least 10 hours, subjects finished a high-fat meal, or a low-fat meal within 30 minutes the next morning (eat up all meals). Glumetinib tablets are orally administered by subjects with 240 mL warm water on 30 minutes after starting the meal. Water is allowed as desired except for 1 hour before and 2 hours after administration (including the meal), and no more than 500 mL of water will be consumed including the water intake during the high-fat meals or low-fat meals, and the water for administration. The subjects will be fasted for at least 4 hours after administration, and then have dinner approximately 9 hours after administration.

Timeline

• Start date: 2021-03-02
• Primary completion: 2021-05-21
• Completion: 2021-09-30
• First posted: 2022-08-18
• Last updated: 2022-08-19

Locations

1 site across 1 country: China