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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

Oppdatert: 8 Juli, 2024   |   ClinicalTrials.gov

Utskriftsvennlig Sammendrag

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Vis detaljer

  • Phase 1

    Fase

  • Kjønn

  • 18-55

    Aldersgruppe

  • 1

    Sted(er)

  • Not Yet Recruiting

Behandlingsalternativer

Studiearmer
TILDELT INTERVENSJON
Experimental: Part 1
Drug: Repotrectinib, Voriconazole
Experimental: Part 2
Drug: Repotrectinib, Quinidine

Nøkkelkriterier for kvalifikasjon

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.

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For å rapportere bivirkninger (uønskede hendelser) eller reklamere på et legemiddel: Medisinsk informasjon

MLTNO2000046