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A Study to Assess the Safety, Tolerability and Effects of Single and Multiple Ascending Doses of ASP1707 in Healthy Male and Pre-menopausal Female Subjects, Including a Comparison of the Effects Under Fasted and Fed Conditions in Healthy Young Male Subjects

17 de febrero de 2015 actualizado por: Astellas Pharma Europe B.V.

A Double Blind, Randomized, Placebo-controlled, Ascending Single and Multiple Oral Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP1707 in Healthy Young and Elderly Male Subjects and in Healthy Pre-menopausal Female Subjects Including an Open-label Comparison of Pharmacokinetics Under Fasted and Fed Conditions in Healthy Young Male Subjects

This study consists of four parts:

Part 1 is a randomized, double-blind, placebo-controlled, single ascending dose study in healthy young male subjects to evaluate the safety, tolerability pharmacokinetics (PK) and effect on certain hormones and if possible to determine the highest well-tolerated dose of ASP1707 in healthy young male subjects under fasted conditions.

Part 2 is an open label, randomized crossover, single dose study to determine the effect of food on the pharmacokinetics of ASP1707and effect on certain hormones in healthy young male subjects.

Part 3 is a randomized, double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety, tolerability and pharmacokinetics (PK) of ASP1707 in healthy elderly men and healthy premenopausal females, and to determine the effect on certain hormones in males. Age and gender is also evaluated.

Part 4 is a randomized, double-blind, placebo-controlled, parallel, multiple dose study to evaluate the safety, tolerability and PK of ASP1707, and its effect on certain hormones in healthy pre-menopausal female subjects.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Part 1 comprises 7 dose groups of 8 healthy young male subjects. ASP1707 or matching placebo ( 3 to 1 ratio) is given as a single dose under fasted conditions.

The first group receives the lowest dose while the last group receives the highest dose.

Part 2 (Food-Effect) The group consists of 12 healthy young male subjects who receive two separate doses of ASP1707 under fasted or fed conditions. Half of the subjects are dosed first under fasted condition and half of them had first an FDA high-fat breakfast. Subjects receive the alternate treatment on the second occasion. Dosing is separated by at least 7 days or 7 times t1/2 (terminal elimination half-life) as assessed from Part 1.

Part 3 Comprises 4 dose groups of 12 healthy elderly men each, and two groups of 12 healthy premenopausal women. The latter are dosed ASP1707 or placebo in parallel to the 4 male groups. Subjects are fasted or fed depending on observations from Part 2.

Dose levels are defined after evaluating interim safety, tolerability and PK and PD results from Part 1. A lower maximum dose is used in women than in men, based on preclinical data. Dose escalation in the men is independent from dose escalation in the women. Women and men receive once-daily dosing;

Part 4 includes 4 groups, 1 placebo and 3 for ASP1707, each with 9 pre-menopausal women. Subjects in each dose group receive a fixed daily dose. Subjects are domiciled for various intervals during each of 3 menstrual cycles. Dosing occurs for 21 Days during the subjects' second menstrual cycle of the study (Day 1 of Period 2); fasted or fed depending on observations from Part 2.

Tipo de estudio

Intervencionista

Inscripción (Actual)

176

Fase

  • Fase 1

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Francia
      • Paris, Francia, 75015
        • SGS Life Science Services, Aster

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

Parts 1 & 2:

  • Healthy young male subject aged 18 to 45 years inclusive
  • Body Mass Index more than or equal to 18.5 and less than 30.0 kg/m2.
  • Male subjects must be non-fertile, or must practice an adequate contraceptive method to prevent pregnancies.

Part 3:

  • Healthy elderly male subject aged 55 years or older, or healthy pre-menopausal female subject aged 18 to 45 inclusive.
  • Body Mass Index more than or equal to 18.5 and less than 30.0 kg/m2.
  • Male subject must be non-fertile, or must practice adequate contraceptive methods.
  • Female subjects must be of non-child bearing potential, i.e. surgically sterilized or practice adequate (double barrier) non-hormonal contraceptive methods.

Part 4:

  • Healthy pre-menopausal female subject aged 18 to 45 inclusive.
  • Body Mass Index more than or equal to 18.5 and less than 30.0 kg/m2.
  • Female subjects must be of non-child bearing potential, i.e. surgically sterilized or practice adequate contraceptive methods.
  • Females having a regular menstruation cycle with a duration between 25 up to 30 days.

Exclusion Criteria:

Parts 1 & 2:

  • Male subjects with out-of-range Testosterone levels in serum at screening.
  • Subjects with any history of cancer.
  • Any of the liver function tests (i.e. ALT and AST) above the upper limit of normal.
  • A QTc interval of > 430 ms after repeated measurements.
  • Regular use of any inducer of metabolism (e.g. barbiturates, rifampin) in the 3 months prior to admission to the Clinical Unit.
  • Positive serology test for HBsAg, anti HAV (IgM), anti-HCV or anti-HIV 1+2.

Part 3:

  • Pregnancy within 6 months before screening assessment or breast feeding 3 months before screening.
  • Male subjects with out-of-range T levels in serum at screening.
  • Positive serology test for HBsAg, anti HAV (IgM), anti-HCV or anti-HIV 1+2.

Part 4:

  • Pregnancy within 6 months before screening assessment or breast feeding 3 months before screening.
  • Use of any hormonal interfering contraceptives in the 3 months before admission (for 3 consecutive menstruation cycles) OR any evidence of unovulatory menstrual cycles.
  • Positive serology test for HBsAg, anti HAV (IgM), anti-HCV or anti-HIV 1+2.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Ciencia básica
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 1. Single ascending dose (SAD), ASP1707 dose levels 1-7
healthy young male
Droga: ASP1707 single dose of dose levels 1 -7
Oral, dose escalation
Experimental: 2. Single ascending dose (SAD), placebo dose levels 1-7
healthy young male
Droga: Placebo single dose of dose levels 1-7
Oral, dose escalation, healthy young male
Experimental: 3. Food effect (FE), ASP1707 fasted
Fasted healthy young male
Droga: ASP1707 single dose fasted
Oral, healthy young male
Experimental: 4. Food effect (FE), ASP1707 fed
Fed healthy young male
Droga: ASP1707 single dose fed
Oral, healthy young male
Experimental: 5. Multiple ascending dose (MAD), ASP1707 dose levels 1-4
healthy elderly male
Droga: ASP1707 multiple dose of dose levels 1-4
Oral, multiple dose escalation, healthy elderly male
Experimental: 6. Multiple ascending dose (MAD), Placebo, dose levels 1-4
healthy elderly male
Droga: Placebo multiple dose of dose levels 1-4
Oral, multiple dose escalation, healthy elderly male
Experimental: 7. Multiple ascending dose (MAD), ASP1707, dose levels 1-2
healthy pre-menopausal female
Droga: ASP1707 multiple dose of dose levels 1-2
Oral, multiple dose escalation, healthy pre-menopausal female
Experimental: 8. Multiple ascending dose (MAD), Placebo dose levels 1-2
healthy pre-menopausal female
Droga: Placebo multiple dose of dose levels 1-2
Oral, multiple dose escalation, healthy pre-menopausal female
Experimental: 9. Parallel multiple dose, ASP1707 dose levels 1-3
healthy pre-menopausal female
Droga: ASP1707 parallel multiple dose of dose levels 1-3
Oral, multiple dose, healthy pre-menopausal female
Experimental: 10. Parallel multiple dose, Placebo
healthy pre-menopausal female
Droga: Placebo parallel multiple dose
Oral, dose escalation, healthy pre-menopausal female

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Safety assessed by nature, frequency and severity of adverse events
Periodo de tiempo: Screening to End of Study Visit (ESV) (up to Day 19 and up to Day 39)
Respectively Part 1 and Part 3
Screening to End of Study Visit (ESV) (up to Day 19 and up to Day 39)
Safety assessed by physical examination
Periodo de tiempo: Screening to End of Study Visit (ESV) (up to Day 19 and up to Day 39)
Respectively Part 1 and Part 3
Screening to End of Study Visit (ESV) (up to Day 19 and up to Day 39)
Safety assessed by vital signs
Periodo de tiempo: Screening to End of Study Visit (ESV) (up to Day 19 and up to Day 39)
Respectively Part 1 and Part 3. Vital signs include blood pressure and pulse.
Screening to End of Study Visit (ESV) (up to Day 19 and up to Day 39)
Safety assessed by safety laboratory tests
Periodo de tiempo: Screening to End of Study Visit (ESV) (up to Day 19 and up to Day 39)
Respectively Part 1 and Part 3, Biochemistry, hematology, and urinalysis
Screening to End of Study Visit (ESV) (up to Day 19 and up to Day 39)
Safety assessed by 12 lead electrocardiogram (ECG)
Periodo de tiempo: Screening to End of Study Visit (ESV) (up to Day 19 and up to Day 39)
Respectively Part 1 and Part 3
Screening to End of Study Visit (ESV) (up to Day 19 and up to Day 39)
Safety assessed by continuous cardiac monitoring (Holter)
Periodo de tiempo: Days -1 and 21
Part 3
Days -1 and 21
Pharmacokinetics (PK) of ASP1707 measured by area under the plasma concentration - time curve (AUC) extrapolated to time = infinity (AUCinf) in plasma
Periodo de tiempo: Pre-dose (Day 1) to Day 5
Part 2
Pre-dose (Day 1) to Day 5
PK of ASP1707 measured by area under the plasma concentration-time curve (AUC) to time from the time of dosing to the last measurable concentration (AUClast) in plasma
Periodo de tiempo: Pre-dose (Day 1) to Day 5
Part 2
Pre-dose (Day 1) to Day 5
PK of ASP1707 measured by time to reach quantifiable concentrations (tlag) in plasma
Periodo de tiempo: Pre-dose (Day 1) to Day 5
Part 2
Pre-dose (Day 1) to Day 5
PK of ASP1707 measured by time to attain maximum concentration (tmax) in plasma
Periodo de tiempo: Pre-dose (Day 1) to Day 5
Part 2
Pre-dose (Day 1) to Day 5
PK of ASP1707 measured by Cmax in plasma
Periodo de tiempo: Pre-dose (Day 1) to Day 5
Part 2
Pre-dose (Day 1) to Day 5
PK of ASP1707 measured by terminal elimination half-life (t1/2) in plasma
Periodo de tiempo: Pre-dose (Day 1) to Day 5
Part 2
Pre-dose (Day 1) to Day 5
PK of ASP1707 measured by apparent volume of distribution (Vz/F) in plasma
Periodo de tiempo: Pre-dose (Day 1) to Day 5
Part 2
Pre-dose (Day 1) to Day 5
PK of ASP1707 measured by apparent clearance (CL/F) in plasma
Periodo de tiempo: Pre-dose (Day 1) to Day 5
Part 2
Pre-dose (Day 1) to Day 5
PK of ASP1707 measured by amount excreted unchanged into urine (Ae) from time of dosing until last measurable concentration (Aelast) in urine
Periodo de tiempo: Pre-dose (Day 1) to Day 5
Part 2
Pre-dose (Day 1) to Day 5
PK of ASP1707 measured by Ae extrapolated to time = infinity (Aeinf) in urine
Periodo de tiempo: Pre-dose (Day 1) to Day 5
Part 2
Pre-dose (Day 1) to Day 5
PK of ASP1707 measured by Ae in % up to the collection time of the last measurable concentration (Aelast%) in urine
Periodo de tiempo: Pre-dose (Day 1) to Day 5
Part 2
Pre-dose (Day 1) to Day 5
PK of ASP1707 measured by Ae in % extrapolated to time infinity (Aeinf%) in urine
Periodo de tiempo: Pre-dose (Day 1) to Day 5
Part 2
Pre-dose (Day 1) to Day 5
PK of ASP1707 measured by renal clearance (CLR) in urine
Periodo de tiempo: Pre-dose (Day 1) to Day 5
Part 2
Pre-dose (Day 1) to Day 5
Pharmacodynamics (PD) of ASP1707 measured by Cmax in plasma
Periodo de tiempo: Day -1 to day 15 for period 1, Day 7 to Day 15 for periods 2 and 3
Part 4, period 1, 2 and 3. Estradiol (E2), Follicle-stimulating hormone (FSH) and Luteinizing Hormone (LH) levels
Day -1 to day 15 for period 1, Day 7 to Day 15 for periods 2 and 3
PD of ASP1707 measured by tmax in plasma
Periodo de tiempo: Day -1 to day 15 for period 1, Day 7 to Day 15 for periods 2 and 3
Part 4, period 1, 2 and 3. E2, FSH and LH levels
Day -1 to day 15 for period 1, Day 7 to Day 15 for periods 2 and 3
PD of ASP1707 measured by average concentration (Cavg, day 7-15) in plasma
Periodo de tiempo: Pre-dose to Day 26
Part 4, period 1, 2 and 3. E2, FSH and LH levels
Pre-dose to Day 26
PD of ASP1707 measured by average concentration (Cavg, day 5-19) in plasma
Periodo de tiempo: Pre-dose to Day 26
Part 4, period 3. E2, FSH and LH levels
Pre-dose to Day 26
PD of ASP1707 measured by average concentration (Cavg, day 23-26) in plasma
Periodo de tiempo: Pre-dose to Day 26
Part 4, period 2. E2, FSH and LH levels
Pre-dose to Day 26
PD of ASP1707 - maximal duration within therapeutic range
Periodo de tiempo: Pre-dose to Day 26
Part 4, period 2. E2 levels
Pre-dose to Day 26
PD of ASP1707 - total duration within therapeutic range (20-50 pg/mL)
Periodo de tiempo: Pre-dose to Day 26
Part 4, period 2. E2 levels
Pre-dose to Day 26
PD of ASP1707 - Time of onset therapeutic range
Periodo de tiempo: Pre-dose to Day 26
Part 4, period 2. E2 levels
Pre-dose to Day 26
PD of ASP1707 - Time of offset therapeutic range
Periodo de tiempo: Pre-dose to Day 26
Part 4, period 2. E2 levels
Pre-dose to Day 26
PD of ASP1707 - Time of start menstruation after last dose of study drug
Periodo de tiempo: Pre-dose to Day 26
Part 4, period 3
Pre-dose to Day 26

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
PK profile of ASP1707 in plasma and urine for Part 1
Periodo de tiempo: Pre-dose (Day 1) to Day 5
AUCinf, AUClast, tlag, tmax, Cmax, t1/2, Vz/F, CL/F, Aelast, Aeinf, Aelast%, Aeinf%, CLR
Pre-dose (Day 1) to Day 5
Safety profile assessed by nature, frequency and severity of adverse events, physical examination, vital signs, safety laboratory tests and 12 lead ECG
Periodo de tiempo: Screening to End of Study Visit (ESV) (Up to 31 days and up to 62 days)
Respectively Part 2 and Part 4
Screening to End of Study Visit (ESV) (Up to 31 days and up to 62 days)
PD profile of ASP1707 for Part 1 and Part 2
Periodo de tiempo: Pre-dose (Day 1) to Day 12-19
Testosterone (T), LH and FSH levels: Cmin, tmin, maximal %Reduction and T only: Number and percentage of subjects with T castration level (= T < 0.5 ng/mL) after single dose, Time of onset of T < 0.5 ng/mL after single dose, Duration of T <0.5 ng/mL after single dose
Pre-dose (Day 1) to Day 12-19
PD profile of ASP1707 for Part 3
Periodo de tiempo: Pre-dose (Day 1) to Day 39
T, LH and FSH levels: Cmin, tmin, maximal %Reduction T only: Number and percentage of subjects with T < 0.5 ng/mL at any time post-first dose, Number and percentage of subjects with T < 0.5 ng/mL after last dose, Number of subjects reaching T<0.5 ng/mL for ≥14 days, Day of onset of T < 0.5 ng/mL after multiple doses of ASP1707 (T < 0.5 ng/mL for the first time), Time of onset of T < 0.5 ng/mL after first dose, Duration of T < 0.5 ng/mL after single dose and during multiple dosing, Total duration, Maximal duration:Time from last dose to return to baseline levels for T, LH and FSH, Duration of T < 0.5 ng/mL after last dose
Pre-dose (Day 1) to Day 39
PK profile of ASP1707 in plasma and urine for Part 3
Periodo de tiempo: Pre-dose (Day 1) to Day 25
AUCinf, AUClast, tlag, tmax, Cmax, t1/2, Vz/F, CL/F, Aelast, Aeinf, Aelast%, Aeinf%, CLR, Ctrough, AUC during the time interval between consecutive dosing (AUCtau), Accumulation Ratio (Rac), Peak Trough Ratio (PTR), Ae during the time interval between consecutive dosing (Aetau), Aetau as percentage of total dose (Aetau%), Ae during the time interval between consecutive dosing (AUCtau), (AUC0-24h), Ae0-24h, Ae0-24h%
Pre-dose (Day 1) to Day 25
PK profile of ASP1707 in plasma and urine for Part 4
Periodo de tiempo: Pre-dose (Day 23) to Day 25
AUCtau, tmax, Cmax, t1/2, Vz/F, CL/F, CLR, Ctrough, PTR, Aetau, Aetau%,
Pre-dose (Day 23) to Day 25

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Astellas Pharma Europe B.V.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de junio de 2010

Finalización primaria (Actual)

1 de agosto de 2011

Finalización del estudio (Actual)

1 de agosto de 2011

Fechas de registro del estudio

Enviado por primera vez

14 de noviembre de 2014

Primero enviado que cumplió con los criterios de control de calidad

17 de febrero de 2015

Publicado por primera vez (Estimar)

23 de febrero de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

23 de febrero de 2015

Última actualización enviada que cumplió con los criterios de control de calidad

17 de febrero de 2015

Última verificación

1 de febrero de 2015

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • 1707-CL-0001
  • 2010-018292-21 (Número EudraCT)

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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