- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02314793
A Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP2205 in Healthy Young Males and Females and Elderly Females and to Evaluate the Effect of Food on the Pharmacokinetics of a Single Dose of of ASP2205
A Phase 1 Single and Multiple Ascending Oral Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP2205 in Healthy Young Males and Females and Elderly Females and to Evaluate the Effect of Food on the Pharmacokinetics of a Single Dose of ASP2205
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Part 1 is a single ascending dose investigator-blinded study in healthy young male and female subjects. Six doses of ASP2205 or matching placebo will be given to separate cohorts consisting of 8 subjects each, with 6 subjects receiving ASP2205 and 2 subjects receiving matching placebo. ASP2205 or matching placebo will be given as a single oral dose under fasted conditions.
The effect of a high-calorie high-fat meal (breakfast) on the safety, tolerability and pharmacokinetics of a single oral dose of ASP2205 will be evaluated in a separate cohort of 8 subjects in an open-label manner.
Part 2 is a multiple ascending dose subject- and investigator-blinded study comprising 3 cohorts with each 12 healthy young (aged 25 to 55 years) female subjects and 1 cohort with 12 healthy elderly (aged 65 years or older) female subjects who will receive ASP2205 or matching placebo. Nine subjects in each cohort will be treated with ASP2205 and 3 subjects will be treated with matching placebo (ratio 3:1).
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Harrow, Reino Unido, HA1 3UJ
- Site GB44001
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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:
- Subject is a healthy young male or female subject aged 25 to 55 years, inclusive, at screening (part 1 and 2) or healthy elderly female subject aged ≥ 65 years, inclusive, at screening (part 2 only).
- Subject has a body mass index (BMI) range of 18.5 - 30.0 kg/m2, inclusive. The subject weighs at least 50 kg (at screening).
- Subject agrees not to participate in another interventional study while participating in the present study, defined as signing the informed consent form until completion of the last study visit.
Exclusion Criteria:
- Female subject who has been pregnant within 6 months prior to screening assessment or breastfeeding within 3 months prior to screening.
- Subject has a known or suspected hypersensitivity to ASP2205 or any components of the formulations used.
- Subject has any of the liver function tests (LTs; aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase (ALP), gamma glutamyl transferase, total bilirubin [TBL]) above the upper limit of normal (ULN). In such a case, the assessment may be repeated once (admission to the clinical unit).
- Subject has at screening any clinically significant history of allergic conditions (including drug allergies, asthma, eczema or anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies).
- Subject has any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic (including surgical procedures to treat pelvic trauma), pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease or malignancy.
- Subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (noncutaneous) infection within 1 week prior to admission to the clinical unit.
- Subject has a relevant history of attempted suicide or suicidal behavior. Any recent suicidal ideation within the last 6 months or who are at significant risk to commit suicide.
- Subject has any clinically significant abnormality.
- Subject has a mean pulse < 40 or > 90 bpm; mean systolic blood pressure (SBP) > 140 mmHg; mean DBP > 90 mmHg (elderly subjects: mean SBP > 160 mmHg; mean DBP > 100 mmHg) (vital signs measurements taken in triplicate after subject has been resting in supine position for 5 minutes; pulse will be measured automatically) prior to the admission to the clinical unit (triplicates taken at screening and on admission to the clinical unit). If the mean blood pressure exceeds the limits above, 1 additional triplicate can be taken.
- Subject has a mean corrected QT interval using Fridericia's formula (QTcF) > 430 ms (for male subjects) and > 450 ms (for female subjects) at admission to the clinical unit. If the mean QTcF exceeds the limits above, 1 additional triplicate ECG can be taken.
- Subject uses any prescribed or nonprescribed drugs (including vitamins, natural and herbal remedies, e.g., St. John's Wort) in the 2 weeks prior to study drug administration, except for occasional use of paracetamol (up to 2 g/day) and except for use of contraceptives or hormone replacement therapy.
- Subject has a history of smoking within 6 months prior to admission to the clinical unit.
- Subject has a history of drinking > 21 units of alcohol per week (1 unit = 10 g pure alcohol = 250 mL of beer [5%] or 35 mL of spirits [35%] or 100 mL of wine [12%]) (> 14 units of alcohol for female subjects) within 3 months prior to admission to the clinical unit.
- Subject uses grapefruit juice (more than 3 × 200 mL) or products containing grapefruit and/or Seville oranges (more than 3 times) in the week prior to admission to the clinical unit until ESV, as reported by the subject.
- Subject uses any drugs of abuse within 3 months prior to admission to the clinical unit.
- Subject regularly uses any inducer of metabolism (e.g., barbiturates, rifampin) in the 3 months prior to admission to the clinical unit.
- Subject had significant blood loss, donated 1 unit (500 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to admission to the clinical unit.
- Subject has a positive serology test for hepatitis B surface antigen (HBsAg), hepatitis A virus antibodies (immunoglobulin M) (anti-HAV [IgM]), hepatitis C virus antibodies (anti-HCV) or antibodies to human immunodeficiency virus type 1 (HIV-1) and/or type 2 (HIV-2) at screening.
- Subject has been treated with any investigational drugs within 90 days or 5 terminal half-lives, whichever is longer, prior to drug administration.
- Subject is unable to communicate, read and understand English, or has any other condition which makes the subject unsuitable for study participation.
- Subject is an employee of the Astellas Group or Clinical Research Organization involved in the study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Part 1: Single Ascending Dose ASP2205 (Fasting)
Young male and female subjects will receive single doses of ASP2205 in a dose escalation format.
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oral
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Comparador de placebos: Part 1: Single Ascending Dose Placebo (Fasting)
Young male and female subjects will receive single doses of matching placebo in a dose escalation format.
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oral
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Experimental: Part 1: Single Ascending Dose ASP2205 (Fed)
Young male and female subjects will receive a single dose of ASP2205
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oral
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Experimental: Part 2: Multiple Ascending Dose ASP2205, Young females
Young female subjects will receive multiple dosing of ASP2205 for 14 days: single doses on days 1 and 14 and depending on the dosing regimen (based on emerging data from Part 1) either once or twice daily dosing from days 2 to 13.
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oral
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Comparador de placebos: Part 2: Multiple Ascending Dose Placebo, Young females
Young female subjects will receive matching placebo for 14 days: single doses on days 1 and 14 and depending on the dosing regimen (based on emerging data from Part 1) either once or twice daily dosing from days 2 to 13.
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oral
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Experimental: Part 2: Multiple Ascending Dose ASP2205, Elderly females
Elderly female subjects will receive multiple dosing of ASP2205 for 14 days: single doses on days 1 and 14 and depending on the dosing regimen (based on emerging data from Part 1) either once or twice daily dosing from days 2 to 13.
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oral
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Comparador de placebos: Part 2: Multiple Ascending Dose Placebo, Elderly females
Elderly female subjects will receive matching placebo for 14 days: single doses on days 1 and 14 and depending on the dosing regimen (based on emerging data from Part 1) either once or twice daily dosing from days 2 to 13.
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oral
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Part 1 and Part 2: Safety assessed by nature, frequency and severity of adverse events
Periodo de tiempo: up to 29 days
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up to 29 days
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Part 1 and Part 2: Safety assessed by vital signs
Periodo de tiempo: up to 29 days
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Vital signs include blood pressure, pulse rate, body temperature
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up to 29 days
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Part 1 and Part 2: Safety assessed by orthostatic challenge test
Periodo de tiempo: up to 29 days
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up to 29 days
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Part 1 and Part 2: Assessment of clinical laboratory tests
Periodo de tiempo: up to 29 days
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Clinical laboratory tests include hematology, biochemistry and urinalysis
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up to 29 days
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Part 1 and Part 2: Safety assessed by routine 12 lead electrocardiogram (ECG)
Periodo de tiempo: up to 29 days
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up to 29 days
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Part 1 and Part 2: Safety assessed by continuous cardiac monitoring (Holter ECG)
Periodo de tiempo: up to 29 days
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up to 29 days
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Part 1: Safety assessed by real-time cardiac monitoring (ECG telemetry)
Periodo de tiempo: up to 16 days
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up to 16 days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Part 1 and Part 2: Safety laboratory test: prolactin
Periodo de tiempo: up to 29 days
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up to 29 days
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Part 1 and Part 2: Safety laboratory test: cortisol
Periodo de tiempo: up to 29 days
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up to 29 days
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Part 1 and Part 2: Safety laboratory test: bicarbonate (HCO3)
Periodo de tiempo: up to 29 days
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up to 29 days
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Part 1 and Part 2: Safety assessed by chemistry profile
Periodo de tiempo: up to 29 days
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Chemistry profile includes total cholesterol, high-density lipoprotein (HDL) / low-density lipoprotein (LDL), triglycerides
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up to 29 days
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Part 1 and Part 2: Safety laboratory test: fasting blood glucose
Periodo de tiempo: up to 29 days
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up to 29 days
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Part 1 and Part 2: Safety laboratory test: creatinine urine
Periodo de tiempo: up to 29 days
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up to 29 days
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Part 1: Central nervous system (CNS) safety monitoring: Bond & Lader visual analogue scale (VAS)
Periodo de tiempo: up to 4 days
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up to 4 days
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Part 1: CNS safety monitoring: Drug effects questionnaire (DEQ) VAS
Periodo de tiempo: up to 4 days
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PhenX toolkit version
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up to 4 days
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Part 1: Pharmacokinetics profile of ASP2205 in plasma: AUCinf, AUCinf (% extrapolated), AUClast, AUC24, CL/F, Cmax, terminal elimination rate constant, MRT, tlag, tmax, t1/2, Vz/F
Periodo de tiempo: Day 1
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Area under the concentration-time curve (AUC) from the time of dosing extrapolated to time infinity (AUCinf), percentage of AUCinf due to extrapolation from tlast to time infinity (AUCinf %extrapolated), AUC from the time of dosing to the last measurable concentration (AUClast), AUC from the time of dosing to 24 hours (AUC24), apparent total systemic clearance after single or multiple extravascular dosing (CL/F), maximum concentration (Cmax), mean residence time (MRT), time prior to the time corresponding to the first measurable (nonzero) concentration (tlag), time to maximum concentration (tmax), terminal elimination half-life (t1/2), apparent volume of distribution during the terminal elimination phase after single or multiple extravascular dosing (Vz/F)
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Day 1
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Part 1: Pharmacokinetics profile of ASP2205 in urine: Aeinf, Aeinf%, Aelast, Aelast%, CLR
Periodo de tiempo: Day 1
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Cumulative amount of drug excreted into urine from time of dosing extrapolated to time infinity (Aeinf), percentage of drug dose excreted into urine from time of dosing extrapolated to time infinity (Aeinf%), cumulative amount of drug excreted into urine from time of dosing up to the collection time of the last measurable concentration (Aelast), percentage of drug dose excreted into urine from time of dosing up to the collection time of the last measurable concentration (Aelast%), renal clearance (CLR)
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Day 1
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Part 2: Safety laboratory test: di-docosahexaenoyl-bis(monoacylglycerol) phosphate (di-22:6-BMP) in serum and urine
Periodo de tiempo: up to 29 days
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up to 29 days
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Part 2: CNS safety monitoring: CogState's neurocognition test battery (short version)
Periodo de tiempo: up to 14 days
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up to 14 days
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Part 2: CNS safety monitoring: Bond & Lader VAS
Periodo de tiempo: up to 17 days
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up to 17 days
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Part 2: CNS safety monitoring: DEQ VAS
Periodo de tiempo: Time Frame : up to 13 days
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PhenX toolkit version
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Time Frame : up to 13 days
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Part 2: CNS safety monitoring: Addiction Research Center Inventory (49-item short form) (ARCI-49)
Periodo de tiempo: up to 13 days
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up to 13 days
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Part 2: CNS safety monitoring: Physician Withdrawal Checklist
Periodo de tiempo: up to 29 days
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up to 29 days
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Part 2: CNS safety monitoring: Columbia - Suicide Severity Rate Scale (C-SSRS)
Periodo de tiempo: up to 29 days
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up to 29 days
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Part 2: Appetite visual analogue scale (AVAS)
Periodo de tiempo: up to 15 days
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up to 15 days
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Part 2: Nausea VAS
Periodo de tiempo: up to 15 days
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From the McGill Nausea questionnaire
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up to 15 days
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Part 2: Body weight
Periodo de tiempo: up to 29 days
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up to 29 days
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Part 2: Total daily urine production (24-hour volume)
Periodo de tiempo: up to 15 days
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up to 15 days
|
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Part 2: Total daily urine osmolality (24 hour pooled sample from each void)
Periodo de tiempo: up to 15 days
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up to 15 days
|
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Part 2: Total daily fluid intake
Periodo de tiempo: up to 15 days
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up to 15 days
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Part 2: Pharmacokinetic profile of ASP2205 in plasma: AUC24, Cmax, tlag, tmax
Periodo de tiempo: Day 1
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Day 1
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Part 2: Pharmacokinetic parameter: Ctrough
Periodo de tiempo: Day 1 immediately prior to dosing (morning Ctrough and, only in case of twice daily dosing, evening C trough): days 2, 4, 6, 8, 10, 12
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Day 1 immediately prior to dosing (morning Ctrough and, only in case of twice daily dosing, evening C trough): days 2, 4, 6, 8, 10, 12
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Part 2: Pharmacokinetic profile of ASP2205 in plasma: AUCtau, Cmax, tmax
Periodo de tiempo: Days 12, 13 (in case of twice daily dosing)
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Days 12, 13 (in case of twice daily dosing)
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Part 2: Pharmacokinetic profile of ASP2205 in plasma: AUCtau, CL/F, Cmax, terminal elimination rate constant, MRT, peak trough ratio (PTR), accumulation ratio calculated using the area under the concentration -time curve [Rac(AUC)], tmax, t1/2, VzF
Periodo de tiempo: Day 14
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Day 14
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Part 2: Pharmacokinetic profile of ASP2205 in urine: Aetau, Aetau%, CLR
Periodo de tiempo: Day 14
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Day 14
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Associate Medical Director, Astellas Pharma Europe B.V.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 2205-CL-0001
- 2014-003059-71 (Número EudraCT)
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