A Pharmacokinetic, Safety and Tolerability Study in Healthy Adult Males
A Randomized, Open Label, Four Period, Cross-Over Study to Evaluate the Pharmacokinetics of Single Doses of Various TRV734 Formulations in Healthy Male Subjects
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Tipo de estudio
Tipo de estudio
Inscripción (Actual)
Inscripción
Fase
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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-
Texas
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San Antonio, Texas, Estados Unidos, 78209
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-
Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Healthy as determined by a responsible physician or trained qualified designee
- Males: 18 - 55 years inclusive at screening
- Capable of giving written informed consent
Exclusion Criteria:
- Clinically significant conditions or history of fainting or syncope
- Medical or psychiatric illness that could interfere with the completion of treatment and follow up
- Major surgery within 4-weeks of screening
- Known difficulty with obtaining intravenous access
- History of sensitivity to the study medication, or intolerance to opioids, or a history of medication or other allergy that contraindicates their participation
- Use of prescription or non-prescription medications
- History of excessive alcohol use
- History of drug abuse within 6 months of screening
- Use of any illegal drug within 30 days of screening and throughout participation in the study
- History of smoking or use of nicotine containing products within 3 months of screening and throughout participation in the study
- Donation of blood or plasma 4 weeks prior to dosing
- Participation in a clinical trial and has received medication within 30 days
- Weight <50 kg or BMI outside range of 18-32 kg/m2
- Positive for HIV antibody, hepatitis B virus surface antigen, or hepatitis C virus
- Unwillingness to abstain from sexual intercourse with a pregnant or lactating woman and, if engaging in sexual intercourse with a female partner of child-bearing potential, use a condom and spermicide, in addition to having their female partner use another form of contraception, and abstain from sperm donation
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
|
Experimental: Formulación A
|
Subjects will be randomized to receive the oral TRV734 treatments on Days 1, 3, 5 and 7 in an open-label, 4-period, cross-over fashion.
Days 2, 4, 6 and 8 are designated as washout days.
|
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Experimental: Formulación B
|
Subjects will be randomized to receive the oral TRV734 treatments on Days 1, 3, 5 and 7 in an open-label, 4-period, cross-over fashion.
Days 2, 4, 6 and 8 are designated as washout days.
|
|
Experimental: Formulación C
|
Subjects will be randomized to receive the oral TRV734 treatments on Days 1, 3, 5 and 7 in an open-label, 4-period, cross-over fashion.
Days 2, 4, 6 and 8 are designated as washout days.
|
|
Experimental: Formulación D
|
Subjects will be randomized to receive the oral TRV734 treatments on Days 1, 3, 5 and 7 in an open-label, 4-period, cross-over fashion.
Days 2, 4, 6 and 8 are designated as washout days.
|
|
Experimental: Formulación E
|
Subjects will be randomized to receive the oral TRV734 treatments on Days 1, 3, 5 and 7 in an open-label, 4-period, cross-over fashion.
Days 2, 4, 6 and 8 are designated as washout days.
|
|
Experimental: Formulación F
|
Subjects will be randomized to receive the oral TRV734 treatments on Days 1, 3, 5 and 7 in an open-label, 4-period, cross-over fashion.
Days 2, 4, 6 and 8 are designated as washout days.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Evaluate the maximum observed plasma concentration (Cmax)
Periodo de tiempo: 9-days
|
9-days
|
|
Evaluate the time at which the maximum plasma concentration was observed (tmax)
Periodo de tiempo: 9-days
|
9-days
|
|
Evaluate the area under the plasma concentration-time curve from time 0 to the last measurable plasma concentration (AUC0-t)
Periodo de tiempo: 9-days
|
9-days
|
|
Evaluate the area under the plasma concentration-time curve from time 0 to time extrapolated to infinity (AUC0-inf)
Periodo de tiempo: 9-days
|
9-days
|
|
Evaluate the apparent elimination half-life (t1/2)
Periodo de tiempo: 9-days
|
9-days
|
|
Evaluate the apparent clearance (CL/F)
Periodo de tiempo: 9-days
|
9-days
|
Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Safety and tolerability as measured by adverse events
Periodo de tiempo: 9-days
|
9-days
|
|
Safety and tolerability as measured by clinical observations
Periodo de tiempo: 9-days
|
9-days
|
|
Safety and tolerability as measured by 12-lead ECGs
Periodo de tiempo: 9-days
|
9-days
|
|
Safety and tolerability as measured by cardiac telemetry monitoring
Periodo de tiempo: 9-days
|
9-days
|
|
Safety and tolerability as measured by vital signs (BP, HR, RR and oral temperature)
Periodo de tiempo: 9-days
|
9-days
|
|
Safety and tolerability as measured by oxygen saturation
Periodo de tiempo: 9-days
|
9-days
|
|
Safety and tolerability as measured by safety laboratory tests
Periodo de tiempo: 9-days
|
9-days
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización primaria
Finalización del estudio (Actual)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
Otros números de identificación del estudio
- CP734-1003
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