- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03478020
Oral AQX-1125 and Combination Oral Contraceptive Drug-Drug Interaction Study (DDI-COC)
Open-Label, Fixed-Sequence 3-Period Study to Determine the Effects of Repeated Oral Dosing of AQX-1125 on the Pharamacokinetics, Safety and Tolerability of a Combination Oral Contraceptive in Healthy Female Subjects
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Groningen, Países Bajos
- PRA Health Sciences - Early Development Serices
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Aged 18-45 years, inclusive, at time of signing Informed Consent
- Adult females of child bearing potential, who are non-pregnant and non-lactating, and must agree to use adequate additional contraception from the start of Treatment Period A until 90 days after the last dose of AQX-1125
- BMI 18.0 - 35.0 kg/m2
- Good physical and mental health based on medical history, physical examination, clinical laboratory, ECG and vital signs, as judged by the investigator
Exclusion Criteria:
- Previous participation in the current study
- Any clinically significant history of breakthrough bleeding
- Using tobacco or other nicotine containing products within 12 months prior to the first study-specific COC-cycle intake
- History of alcohol abuse or drug addiction
- Positive drug and alcohol screen at screening and (each) admission to the clinical research center
- Average intake of more than 24 units of alcohol per week
- Positive screen for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies or anti-human immunodeficiency virus (HIV) 1 and 2 antibodies
- Participation in a drug study within 30 days prior to screening. Participation in more than 2 other drug studies in the 10 months prior to (the first) drug administration in the current study
- Donation or loss of more than 100 mL of blood within 60 days prior to the start of Treatment Period A, on Day 1. Donation or loss of more than 1.0 liters of blood in the 10 months prior to the start of Treatment Period A, on Day 1
- Significant and/or acute illness within 5 days prior to Day 1 in Treatment Period A, that may impact safety assessments, in the opinion of the investigator
- Unsuitable veins for blood sampling
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Pre-Treatment, Treatment Cycles A & B
Pre-Treatment: Two cycles of a combined oral contraceptive (COC) taken orally once daily for 21 days followed by 7 COC-free days. Treatment Period A: COC containing taken orally once daily for 21 days followed by 7 COC-free days. Treatment Period B: COC taken orally once daily for 21 days, with once daily oral 200 mg AQX-1125 (2 x 100 mg tablets) co-administered from Day 13 to 21, followed by 7 COC-free days |
Investigational Drug
COC containing 100 ug Levonorgestrel (LNG) and 20 ug Ethinyl Estradiol (EE)
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Maximum observed plasma concentration (Cmax) of COC taken with AQX-1125
Periodo de tiempo: 8 Weeks (from start of treatment period A to completion of treatment period B)
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To assess the effect of multiple doses of 200 mg AQX-1125 once daily (qd) on the pharmacokinetics (PK) of the COC
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8 Weeks (from start of treatment period A to completion of treatment period B)
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Time to attain maximum observed plasma concentration (tmax) of COC taken with AQX-1125
Periodo de tiempo: 8 Weeks (from start of treatment period A to completion of treatment period B)
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To assess the effect of multiple doses of 200 mg AQX-1125 once daily (qd) on the pharmacokinetics (PK) of the COC
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8 Weeks (from start of treatment period A to completion of treatment period B)
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Area under the plasma concentration-time curve up to 24 hours (AUC0-24) of COC taken with AQX-1125
Periodo de tiempo: 8 Weeks (from start of treatment period A to completion of treatment period B)
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To assess the effect of multiple doses of 200 mg AQX-1125 once daily (qd) on the pharmacokinetics (PK) of the COC
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8 Weeks (from start of treatment period A to completion of treatment period B)
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Terminal elimination rate constant (Kel) of COC taken with AQX-1125
Periodo de tiempo: 8 Weeks (from start of treatment period A to completion of treatment period B)
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To assess the effect of multiple doses of 200 mg AQX-1125 once daily (qd) on the pharmacokinetics (PK) of the COC
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8 Weeks (from start of treatment period A to completion of treatment period B)
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Terminal elimination half-life (t1/2) of COC taken with AQX-1125
Periodo de tiempo: 8 Weeks (from start of treatment period A to completion of treatment period B)
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To assess the effect of multiple doses of 200 mg AQX-1125 once daily (qd) on the pharmacokinetics (PK) of the COC
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8 Weeks (from start of treatment period A to completion of treatment period B)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Safety and tolerability of AQX-1125 200 mg qd administered with the COC
Periodo de tiempo: 16 weeks (from start of pre-treatment cycle 1 to completion of treatment period B)
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Safety and tolerability will be assessed by the severity and frequency of adverse events, which will include any abnormal clinically significant vital signs, laboratory tests, electrocardiogram and physical examination findings
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16 weeks (from start of pre-treatment cycle 1 to completion of treatment period B)
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Maximum observed plasma concentration (Cmax) of AQX-1125 taken with COC
Periodo de tiempo: 8 Weeks (from start of treatment period A to completion of treatment period B)
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To assess the PK of 200 mg AQX-1125 qd when given together with the COC
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8 Weeks (from start of treatment period A to completion of treatment period B)
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Time to attain maximum observed plasma concentration (tmax) of AQX-1125 taken with COC
Periodo de tiempo: 8 Weeks (from start of treatment period A to completion of treatment period B)
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To assess the PK of 200 mg AQX-1125 qd when given together with the COC
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8 Weeks (from start of treatment period A to completion of treatment period B)
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Area under the plasma concentration-time curve up to 24 hours (AUC0-24) of AQX-1125 taken with COC
Periodo de tiempo: 8 Weeks (from start of treatment period A to completion of treatment period B)
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To assess the PK of 200 mg AQX-1125 qd when given together with the COC
|
8 Weeks (from start of treatment period A to completion of treatment period B)
|
Terminal elimination rate constant (Kel) of AQX-1125 taken with COC
Periodo de tiempo: 8 Weeks (from start of treatment period A to completion of treatment period B)
|
To assess the PK of 200 mg AQX-1125 qd when given together with the COC
|
8 Weeks (from start of treatment period A to completion of treatment period B)
|
Terminal elimination half-life (t1/2) of AQX-1125 taken with COC
Periodo de tiempo: 8 Weeks (from start of treatment period A to completion of treatment period B)
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To assess the PK of 200 mg AQX-1125 qd when given together with the COC
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8 Weeks (from start of treatment period A to completion of treatment period B)
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- AQX-1125-104
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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