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Rechercher Study Connect

Not Yet Recruiting

A Study to Assess the Effect of Voriconazole and Quinidine on the Pharmacokinetics of a Single Dose of Repotrectinib in Healthy Participants - CA127-1072

Mis à jour: 8 juillet, 2024   |   ClinicalTrials.gov

Résumé imprimable

VOUS ENVISAGEZ CET ESSAI ?
Imprimer cette page et le guide d’essai pour vous aider à parler avec votre médecin.
Utiliser le Guide du participant à l’étude pour découvrir comment participer à un essai clinique. Comprendre les principaux facteurs à envisager avant de prendre une décision et poser des questions à votre équipe soignante.

Détails de l’essai

  • Phase 1

    Phase

  • Sexe(s)

  • 18-55

    Tranche d’âge

  • 1

    Site(s)

  • Not Yet Recruiting

Options de traitement

Bras de l’étude
INTERVENTION ASSIGNÉE
Experimental: Part 1
Drug: Voriconazole, Repotrectinib
Experimental: Part 2
Drug: Quinidine, Repotrectinib

Principaux critères d’éligibilité

Inclusion Criteria - Healthy male and female individual(s) not of childbearing potential (INOCBP) participants of any race or ethnicity, as determined by no clinically significant findings in medical history, physical examination, 12-lead ECG, or vital signs as determined by the investigator or designee. - Potassium, magnesium, and calcium at or above the lower limit of normal. For other clinical laboratory parameters, no clinically significant findings as determined by the investigator or designee. - Must have a body mass index between 18 and 30 kg/m2 (inclusive) and body weight ≥ 50 kg at the time of signing the ICF. Exclusion Criteria - History of clinically significant acute or chronic medical illness, such as endocrine, gastrointestinal (GI), cardiovascular, peripheral vascular, hematological, hepatic, immunological, renal, respiratory, neoplastic, or genitourinary abnormalities/diseases as determined by the investigator or designee. - History of GI disease or surgery that could possibly affect drug absorption, distribution, metabolism, and excretion (ADME) (eg, bariatric procedure, cholecystectomy). Uncomplicated appendectomy and hernia repair are acceptable. - Gilbert's syndrome. - Other protocol-defined Inclusion/Exclusion criteria apply.

Nous vous recommandons vivement de contacter BMS pour signaler les effets secondaires (événements indésirables)
Les effets secondaires (événements indésirables) et les autres événements à signaler sont définis ici
Signaler des plaintes concernant des effets indésirables (effets indésirables) ou des produits: Informations médicales