Drug-drug Interaction (DDI) Study to Assess Effect of Itraconazole and Rifampicin Upon Olorofim

A Phase I, Open Label Study in Healthy Subjects to Evaluate the Effect of Itraconazole and Rifampicin Upon the Pharmacokinetics of a Single Oral Dose of Olorofim.

Patrocinadores

Patrocinador principal: F2G Ltd.

Colaborador: Hammersmith Medicines Research

Fuente F2G Ltd.
Resumen breve

This is a Phase 1, single-centre, fixed-sequence, open label, drug-drug interaction study in 2 groups of healthy subjects.

Group A: to evaluate the effects of itraconazole, a strong inhibitor of cytochrome P450 3A (CYP3A), upon the pharmacokinetics of olorofim .

Group B: t o evaluate the effects rifampicin, a strong inducer of CYP3A, upon the pharmacokinetics of olorofim .

Estado general Completed
Fecha de inicio November 18, 2019
Fecha de Terminación February 11, 2020
Fecha de finalización primaria February 11, 2020
Fase Phase 1
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
maximum plasma concentration (Cmax) for olorofim. 16 days
Area under the concentration-time curve to time of last quantifiable concentration (AUC0-tlast) for olorofim. 16 days
Resultado secundario
Medida Periodo de tiempo
Time to Cmax (Tmax) of olorofim 16 days
area under the concentration-time curve to infinity (AUC0-∞) for olorofim 16 days
terminal elimination half-life (t½) for olorofim 16 days
Number of subjects with treatment-related adverse events 23 days
Inscripción 24
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: Itraconazole oral solution

Descripción: 200 mg once daily on Days 6 to 15

Etiqueta de grupo de brazo: Cohort A

Tipo de intervención: Drug

Nombre de intervención: Rifampicin Oral Capsule

Descripción: 600 mg once daily on Days 6 to 15

Etiqueta de grupo de brazo: Cohort B

Tipo de intervención: Drug

Nombre de intervención: Olorofim

Descripción: Single oral dose on Days 1 and 11

Otro nombre: F901318

Elegibilidad

Criterios:

Inclusion Criteria:

- males or females of any ethnic origin between 18 and 55 years of age

- subjects weighing between 50 and 100 kg, with a body mass index (BMI) between 18 and 32 kg/m2.

- subjects in good health, as determined by a medical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations

Exclusion Criteria:

- Female subjects of child-bearing potential.

- Male subjects (or their partners) who are not willing to use appropriate contraception during the study and for 3 months after end of dosing.

- Female subjects who are pregnant or lactating.

- Subjects who have received any prescribed systemic or topical medication within 14 days of first dose administration

- Subjects who have used any non-prescribed systemic or topical medication within 7 days of first dose administration

- Subjects who have received any medications, including St John's Wort, known to chronically alter drug absorption or elimination processes within 30 days of first dose administration

- Subjects with or history of clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatry, respiratory, metabolic, endocrine, ocular haematological or other major disorders as determined by the investigator

Género: All

Edad mínima: 18 Years

Edad máxima: 55 Years

Voluntarios Saludables: Accepts Healthy Volunteers

Oficial general
Apellido Papel Afiliación
Adeep Puri Principal Investigator Hammersmith Medicines Research
Ubicación
Instalaciones: Hammersmith Medicines Research
Ubicacion Paises

United Kingdom

Fecha de verificación

November 2019

Fiesta responsable

Tipo: Sponsor

Tiene acceso ampliado No
Número de brazos 2
Grupo de brazo

Etiqueta: Cohort A

Tipo: Other

Descripción: Itraconazole DDI

Etiqueta: Cohort B

Tipo: Other

Descripción: Rifampicin DDI

Datos del paciente No
Información de diseño del estudio

Asignación: Non-Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Other

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov