Single Dose Glumetinib in Healthy Chinese Male Subjects

NCT05507294 | Completed Phase 1

• 1 other identifier: SCC244-106
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Healthy Chinese Male Subjects; SCC244; Food effect

Outcome Measures

Primary Outcomes (7)

• AUC0-inf

  Area Under the Concentration-time Curve from Time zero to Infinity

  Blood samples are collected pre-dose, 0.5, 1, 2, 2.5,3, 3.5,4, 6, 8, 12, 24,36, 48, 72, 96,120, 168 hours post dose)

• AUC0-t

  Area Under the Concentration-Time Curve from Time Zero to Last Measurable Time Point

  Blood samples are collected pre-dose, 0.5, 1, 2, 2.5,3, 3.5,4, 6, 8, 12, 24,36, 48, 72, 96,120, 168 hours post dose

• Cmax

  Maximum Plasma Concentration

  Blood samples are collected pre-dose, 0.5, 1, 2, 2.5,3, 3.5,4, 6, 8, 12, 24,36, 48, 72, 96,120, 168 hours post dose

• Tmax

  Time at Maximum Plasma Concentration (Cmax)

  Blood samples are collected pre-dose, 0.5, 1, 2, 2.5,3, 3.5,4, 6, 8, 12, 24,36, 48, 72, 96,120, 168 hours post dose

• t1/2

  Half-Life

  Blood samples are collected pre-dose, 0.5, 1, 2, 2.5,3, 3.5,4, 6, 8, 12, 24,36, 48, 72, 96,120, 168 hours post dose

• CL/F

  Apparent Clearance

  Blood samples are collected pre-dose, 0.5, 1, 2, 2.5,3, 3.5,4, 6, 8, 12, 24,36, 48, 72, 96,120, 168 hours post dose

• V/F

  Apparent Volume of Distribution

  Blood samples are collected pre-dose, 0.5, 1, 2, 2.5,3, 3.5,4, 6, 8, 12, 24,36, 48, 72, 96,120, 168 hours post dose

Study Arms (6)

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

EXPERIMENTAL

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.

Drug: Glumetinib

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

EXPERIMENTAL

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.

Drug: Glumetinib

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

EXPERIMENTAL

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.

Drug: Glumetinib

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

EXPERIMENTAL

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.

Drug: Glumetinib

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

EXPERIMENTAL

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.

Drug: Glumetinib

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

EXPERIMENTAL

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.

Drug: Glumetinib

Interventions

Glumetinib DRUG

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.

Also known as: SCC244

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Subjects should be able to communicate well with the investigator and comply with the requirements of the clinical study.

You may not qualify if:

• 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.
• Positive results for hepatitis B virus surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibody, treponema pallidum antibody; and non-negative for human immunodeficiency virus (HIV) antibody.
• Subjects who has any of the following conditions within a certain period before the screening/baseline (i.e., the day before the first period of administration, D-1) examination
• Consumed foods that affect the liver drug enzyme CYP3A4 (such as grapefruit or beverages containing grapefruit) or foods or beverages rich in xanthine (such as chocolate, coffee, red bull, etc.) within 48 hours before administration.
• Use any over-the-counter drugs (including vitamins and herbal supplements, etc., except vitamin-containing beverages) within one week.
• Use of any prescription drug within 2 weeks or less than 5 half-lives between the last prescription drug and the first dose of Glumetinib, whichever is shorter.

Sponsors & Collaborators

• Haihe Biopharma Co., Ltd.: lead

Study Sites (1)

Zhongshan Hositpal

Shanghai, Shanghai Municipality, 200020, China

Location

MeSH Terms

Interventions

glumetinib

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2022
• First Posted: August 18, 2022
• Study Start: March 2, 2021
• Primary Completion: May 21, 2021
• Study Completion: September 30, 2021
• Last Updated: August 19, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)