Clinical Trials/NCT05507294

NCT05507294

Completed

Phase 1

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

Haihe Biopharma Co., Ltd.1 site in 1 country18 target enrollmentMarch 2, 2021

ConditionsHealthy Volunteers

InterventionsGlumetinib

Overview

Phase: Phase 1
Intervention: Glumetinib
Conditions: Healthy Volunteers
Sponsor: Haihe Biopharma Co., Ltd.
Enrollment: 18
Locations: 1
Primary Endpoint: Cmax
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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)

Registry

clinicaltrials.gov

Start Date

March 2, 2021

End Date

September 30, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

Haihe Biopharma Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects has to meet all of the following criteria for study entry:
•Healthy Chinese male subjects are 18 to 45 years of age, inclusive. "Healthy" in this criterion refers to normal results of medical history interview, physical examinations, vital sign measurements, clinical laboratory tests, chest X-ray (posteroanterior \[PA\]) and 12-lead electrocardiogram (ECGs), or abnormalities with no clinical significance as judged by the investigator.
•Bodyweight ≥50.0 kg and body mass index (BMI) are between 19.00 and 26.00 kg/m2, inclusive.
•Subjects should be able to take adequate and effective contraceptive measures and to avoid sperm donation during the study (from the informed consent form \[ICF\] signed to the last visit completed), and within 6 months after the end of the study.
•Adequate and effective contraception is defined as the following:
•Complete abstinence: If it is consistent with subject's preference or lifestyle.
•Adhere to the correct use of one of the following birth control measures:
•Use of an intra-uterine device (IUD) by the subject's female partner; or
•Barrier measures such as diaphragm or condom.
•Subjects should sign the ICF voluntarily and understand the purpose, process and risks of the study.

Exclusion Criteria

•Subjects who has any of the following diseases or conditions
•Known malignancy or psychiatric disorder.
•Known to suffer from acute/chronic bronchospasm (asthma, chronic obstructive pulmonary disease, etc.), pulmonary fibrosis, pulmonary tuberculosis and other diseases that affect respiratory function.
•Has a history of diabetes mellitus and/or pancreatitis.
•History of major gastrointestinal surgery (except appendicitis surgery, anal prolapse surgery), such as gastrectomy, gastroenterostomy, enterectomy, gastric bypass, gastric division or gastric banding, etc.
•Headache ≥2 per week and duration ≥30 minutes within 3 months, or headache episode within 1 week before administration.
•Subjects who has any of the following diseases or clinically significant abnormalities at the screening examination
•Suffering from allergic diseases (such as allergic rhinitis, allergic asthma), had a history of systemic allergic reactions, allergies to any component of the study drug or allergies to similar drugs
•Uncured pulmonitis, blood system, respiratory system, cardiovascular and cerebrovascular system, and digestive system disorders with clinical significance, and any known diseases that may affect drug absorption, distribution, metabolism and excretion.
•Mean corrected QT interval (QTcF) at rest \> 450 ms by 12-lead ECG, or other abnormalities with clinical significance in the opinion of the investigator.

Arms & Interventions

SCC244：Fasting+High-fat meal+Low-fat meal

Participants will receive a single oral dose of Glumetinib tablet in fasting condition on Day 1 of treatment period 1 followed by a single oral dose of Glumetinib tablet in fed condition(High-fat meal) on Day 1 of treatment period 2.Then，Participants will receive a single oral dose of Glumetinib tablet in fed condition （Low-fat meal）on Day 1 of treatment period 3. The time interval between two adjacent dosages was at least 14 days.

Intervention: Glumetinib

SCC244：Fasting+Low-fat meal+High-fat meal

Participants will receive a single oral dose of Glumetinib tablet in fasting condition on Day 1 of treatment period 1 followed by a single oral dose of Glumetinib tablet in fed condition(Low-fat meal) on Day 1 of treatment period 2.Then，Participants will receive a single oral dose of Glumetinib tablet in fed condition （High-fat meal）on Day 1 of treatment period 3. The time interval between two adjacent dosages was at least 14 days.

Intervention: Glumetinib

SCC244：High-fat meal+Fasting+Low-fat meal

Participants will receive a single oral dose of Glumetinib tablet in fed condition（High-fat meal） on Day 1 of treatment period 1 followed by a single oral dose of Glumetinib tablet in fasting condition on Day 1 of treatment period 2.Then，Participants will receive a single oral dose of Glumetinib tablet in fed condition(Low-fat meal) on Day 1 of treatment period 3. The time interval between two adjacent dosages was at least 14 days.

Intervention: Glumetinib

SCC244：High-fat meal+Low-fat meal+Fasting

Participants will receive a single oral dose of Glumetinib tablet in fed condition（High-fat meal） on Day 1 of treatment period 1 followed by a single oral dose of Glumetinib tablet in fed condition（Low-fat meal） on Day 1 of treatment period 2.Then，Participants will receive a single oral dose of Glumetinib tablet in fasting condition on Day 1 of treatment period 3. The time interval between two adjacent dosages was at least 14 days.

Intervention: Glumetinib

SCC244：Low-fat meal+Fasting+ High-fat meal

Participants will receive a single oral dose of Glumetinib tablet in fed condition（Low-fat meal） on Day 1 of treatment period 1 followed by a single oral dose of Glumetinib tablet in fasting condition on Day 1 of treatment period 2.Then，Participants will receive a single oral dose of Glumetinib tablet in fed condition(High-fat meal) on Day 1 of treatment period 3. The time interval between two adjacent dosages was at least 14 days.

Intervention: Glumetinib

SCC244：Low-fat meal +High-fat meal +Fasting

Participants will receive a single oral dose of Glumetinib tablet in fed condition（Low-fat meal） on Day 1 of treatment period 1 followed by a single oral dose of Glumetinib tablet in fed condition（High-fat meal） on Day 1 of treatment period 2.Then，Participants will receive a single oral dose of Glumetinib tablet in fasting condition on Day 1 of treatment period 3. The time interval between two adjacent dosages was at least 14 days.

Intervention: Glumetinib