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A Study of AB-106 in Chinese Healthy Adult Men Evaluated the Effects of Itraconazole and Rifampicin on AB-106 PK

27 avril 2022 mis à jour par: AnHeart Therapeutics Inc.

A Phase I, Single-center, Open-label, Fixed-sequence Study of AB-106 in Chinese Healthy Adult Men Evaluated the Effects of Itraconazole and Rifampicin on AB-106 Pharmacokinetics

AB-106-C110 is China-only study, for investigating the drug interaction between AB-106 and CYP3A4 inhibitor (Itraconazole)/CYP3A4 inducer (Rifampin)(n=56)

Aperçu de l'étude

Statut

Complété

Les conditions

Type d'étude

Interventionnel

Inscription (Réel)

56

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

      • Beijing, Chine
        • Xuanwu Hospital of Capital Medical University

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 55 ans (Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Homme

La description

Inclusion Criteria:

  1. The subject is willing to give written informed consent.
  2. The subject is capable to communicate well with investigator and comply with comply with protocol throughout the study.
  3. Aged between 18 to 55 at giving written informed consent.
  4. Chinese male healthy subjects (No clinical abnormality by medical history query, physical examination, vital signs, 12 lead ECG and clinical laboratory test)
  5. Body weight greater than 50.0 kg, and body mass index between 19 and 26 kg/m2, inclusive.
  6. For fertile males, agree to use effective contraception methods during the study intervention period and for at least 90 days after the last dose of investigational drug, and agree not to donate sperm during this period.

Exclusion Criteria:

  1. Any presence or history of clinically significant hematology, nephrology, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, mental, neurological, or allergic diseases (including drug allergy, but not including untreated, asymptomatic seasonal allergies when administered).
  2. Any clinically significant laboratory abnormality (hematology, biochemistry [fasting], coagulation, thyroid function, urinalysis.)
  3. systolic blood pressure (SBP) < 90 mmHg or ≥140 mmHg, diastolic blood pressure (DBP) < 50 mmHg or ≥ 90 mmHg, and clinically significant abnormality based on the judgment of investigators
  4. Any presence or history of eye disease in whom the risk is increased by the participation to the study or treatment with investigational drug in the opinion of the investigator, such as glaucoma, retinal detachment, vitreous turbidity, and moths.
  5. The 12-lead ECG showed QTcF > 450 milliseconds (msec) or QRS interval > 120 msec. If QTcF exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times, and the average of 3 QTcF or QRS values should be used to determine subject's eligibility.
  6. Fever within 5 days before the administration.
  7. Active hepatitis B virus (HBV) surface antigen, hepatitis C virus antibody (HCV Ab), human immunodeficiency virus (HIV) or treponema pallidum (TP) antibody
  8. Within 28 days prior to the first dose of study treatment, use of food or drugs that are known potent CYP3A4 inhibitors including (but not limited to) atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, aceto-eandomycin, voriconazole, grapefruit, grapefruit juice, grapefruit, citrus fruits or grapes Pomelo mixed species; or potent CYP3A4 inducers including (but not limited to) carbamazepine, phenobarbital, phenytoin, rifabutin, and rifampin and St. John's wort; or CYP3A4 substrates with narrow therapeutic window including (but not limited to)dihydroergotamine, ergotamine, pimozide, astemizole, cisapride, and terfenadine.
  9. Chinese herbal medicine or tonic must be withdrawn at least 28 days prior to the first dose of study treatment; Any clinical study drug is prohibited within 3 months or 5 half-lives prior to the first dose of investigational drug; Any prescription/over-the-counter drug/dietary supplement is prohibited within 14 days or 5 half-lives prior to the first dose of investigational drug; as an exception, acetaminophen/paracetamol can be used at a dose of 1 g/day.
  10. Vaccinated with live or attenuated vaccine within 28 days prior to the first dose of study treatment
  11. Subject is unwilling to withdraw foods containing caffeine or purines (such as coffee, tea, cola, chocolate) from 48h before first dose to finishing the last PK sample collection.
  12. Alcohol intake is greater than 14 units/week (1 unit of alcohol is equivalent to 360 mL of beer, or 150 mL of wine, or 45 mL of baijiu), or subject is unwilling to withdraw alcohol from 48h before first dose to finishing the last PK sample collection.
  13. Smoking more than 5 cigarette per day, or subject is unwilling to withdraw nicotine from 48h before first dose to finishing the last PK sample collection.
  14. Any drug abuse, or taking any soft drug (such as marijuana) or hard drugs (heroin, cocaine, etc.) from 1 year before and during the study period.
  15. Any significant surgical history within 6 months prior to the first dose of study treatment.
  16. Blood donation or blood loss ≥ 400 mL within 3 months or ≥ 200 mL within 1 month prior to the first dose of study treatment.
  17. Presence of gastrointestinal, liver, kidney disease or other diseases or sequelae that are known to interfere with drug absorption, distribution, metabolism, or excretion. With a history of sensitivity to heparin or heparin-induced thrombocytopenia
  18. Unwilling or incapable to follow the lifestyle standard described in the protocol.
  19. Staff members of any institution affiliated with the clinical site and their immediate family members. Immediate family members refer to persons with blood or legal relationship, including spouses, children, parents, and siblings.
  20. Ineligible to participate in the study based on the judgement of investigators

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: Traitement
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Itraconazole cohort
single dose AB-106 at Day1, Itraconazole QD at Day14~Day28, single dose AB-106 at Day17
Expérimental: Rifampicin cohort
single dose AB-106 at Day1, Itraconazole QD at Day14~Day32, single dose AB-106 at Day21

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
AB-106 PK Exposure Parameters
Délai: 29 days
Peak Plasma Concentration (Cmax)
29 days
AB-106 PK Exposure Parameters
Délai: 29 days
Area under the plasma concentration versus time curve (AUC)
29 days

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
AB-106 PK Parameters
Délai: 29 days
Time to drug peak plasma concentration (Tmax)
29 days
AB-106 PK Parameters
Délai: 29 days
Percentage of area under the curve from time of the last quantifiable concentration to infinity to area under the curve to infinity (AUC_extr%)
29 days
AB-106 PK Parameters
Délai: 29 days
Lambda_z, first-order rate constant associated with the terminal portion of the curve (λz)
29 days
AB-106 PK Parameters
Délai: 29 days
Terminal phase elimination half life (t1/2)
29 days
AB-106 PK Parameters
Délai: 29 days
Apparent total clearance (CL/F)
29 days
AB-106 PK Parameters
Délai: 29 days
Apparent volume of distribution (Vz/F)
29 days
Safety Assessment
Délai: 47 days
Adverse events (AEs)
47 days

Collaborateurs et enquêteurs

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

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)

19 juillet 2021

Achèvement primaire (Réel)

3 décembre 2021

Achèvement de l'étude (Réel)

3 décembre 2021

Dates d'inscription aux études

Première soumission

9 juillet 2021

Première soumission répondant aux critères de contrôle qualité

27 avril 2022

Première publication (Réel)

3 mai 2022

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

3 mai 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

27 avril 2022

Dernière vérification

1 avril 2022

Plus d'information

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur Tumeur solide

Essais cliniques sur AB-106, Itraconazole

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