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Bardoxolone methyl capsules 10…
Effect of Itraconazole on the Pharmacokinetics of Bardoxolone Methyl in Healthy Adults
Ensayo de BIOGEN INC. en Voluntarios sanos.
- Fase
- Fase 1
- Estado
- Completado
- Participantes
- 16
- Centros
- 1
- Fin del objetivo primario
- nov 2017
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, de un solo grupo, abierto. Comenzó en oct 2017.
Qué mide
Area under the plasma concentration-time curve of bardoxolone methyl from time 0 to the last measurable time point (AUC0-t). (del registro, en inglés) (28 dias)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis trial will study the impact of a strong CYP3A4 inhibitor (itraconazole) on the pharmacokinetics of bardoxolone methyl (RTA 402) in healthy adult subjects. This is an open-label, fixed-sequence crossover pharmacokinetic (PK) study in healthy volunteers. Subjects will complete a screening visit within 28 days of Study Day 1. Subjects must qualify for the study based on inclusion/exclusion criteria. For Period 1, all qualified subjects shall receive a single oral dose of bardoxolone methyl (10 mg) on Day 1. For Period 2, following a washout of 14 days, itraconazole (SPORANOX®) capsules (100 mg) will be administered as a 200-mg single daily dose on Study Days 15 through 27, with bardoxolone methyl (10 mg) administered on Day 18 (1 hour after itraconazole administration). Bardoxolone methyl doses will be administered under fasted conditions. Itraconazole will be administered under fed conditions on Study Days 15-17, and Study Days 19-27. On study Day 18, itraconazole will be administered under fasted conditions. Subjects will be confined beginning on Study Day -1 through the last blood sample collection on Study Day 9 during Period 1, and from Study Day 14 through the last PK blood draw on Study Day 28 during Period 2.
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Todos los de BIIB, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT03264079), actualizada en may 2025.