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Single Dose Glumetinib in Healthy Chinese Male Subjects

17 août 2022 mis à jour par: Haihe Biopharma Co., Ltd.

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

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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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)

Type d'étude

Interventionnel

Inscription (Réel)

18

Phase

  • La phase 1

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Chine
    • Shanghai
      • Shanghai, Shanghai, Chine, 200020
        • Zhongshan Hositpal

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 45 ans (Adulte)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Homme

La description

Inclusion Criteria:

  • Subjects has to meet all of the following criteria for study entry:

    1. 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.
    2. Bodyweight ≥50.0 kg and body mass index (BMI) are between 19.00 and 26.00 kg/m2, inclusive.

    3. 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:

        1. Use of an intra-uterine device (IUD) by the subject's female partner; or
        2. Barrier measures such as diaphragm or condom.
    4. Subjects should sign the ICF voluntarily and understand the purpose, process and risks of the study.
    5. Subjects should be able to communicate well with the investigator and comply with the requirements of the clinical study.

Exclusion Criteria:

  • Subjects who has any of the following diseases or conditions

    1. Known malignancy or psychiatric disorder.
    2. Known to suffer from acute/chronic bronchospasm (asthma, chronic obstructive pulmonary disease, etc.), pulmonary fibrosis, pulmonary tuberculosis and other diseases that affect respiratory function.
    3. Has a history of diabetes mellitus and/or pancreatitis.
    4. History of major gastrointestinal surgery (except appendicitis surgery, anal prolapse surgery), such as gastrectomy, gastroenterostomy, enterectomy, gastric bypass, gastric division or gastric banding, etc.

    5. 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

    6. 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
    7. 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.
    8. 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.

    9. 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

    10. 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.
    11. Use any over-the-counter drugs (including vitamins and herbal supplements, etc., except vitamin-containing beverages) within one week.
    12. 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.
    13. Smoking ≥5 cigarettes per day within 3 months or unable to refrain from smoking during the study.
    14. Regular drinkers (exceeding 2 units of alcohol per day on average [1 unit = 360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine]) within 3 months or a positive alcohol breath test at screening/baseline.
    15. History of drug abuse within 12 months before screening examination or positive urine drug abuse screening test during the screening/baseline.
    16. Blood donation or blood loss ≥300 mL within 3 months.
    17. Participation in any other clinical studies (including clinical studies of drugs and medical devices) within 3 months.
    18. Other conditions that the investigator considered inappropriate for the subject to participate in the clinical trial.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Recherche sur les services de santé
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation croisée
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Médicament: 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.

Autres noms:
  • SCC244
Expérimental: 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.
Médicament: 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.

Autres noms:
  • SCC244
Expérimental: 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.
Médicament: 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.

Autres noms:
  • SCC244
Expérimental: 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.
Médicament: 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.

Autres noms:
  • SCC244
Expérimental: 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.
Médicament: 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.

Autres noms:
  • SCC244
Expérimental: 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.
Médicament: 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.

Autres noms:
  • SCC244

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
AUC0-inf
Délai: 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)
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
Délai: 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
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
Délai: 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
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
Délai: 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
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
Délai: 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
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
Délai: 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
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
Délai: 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
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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Haihe Biopharma Co., Ltd.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

2 mars 2021

Achèvement primaire (Réel)

21 mai 2021

Achèvement de l'étude (Réel)

30 septembre 2021

Dates d'inscription aux études

Première soumission

17 août 2022

Première soumission répondant aux critères de contrôle qualité

17 août 2022

Première publication (Réel)

18 août 2022

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

19 août 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

17 août 2022

Dernière vérification

1 août 2022

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • SCC244-106

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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