- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02139826
Relative Bioavailability and Food Effect Study of IX-01 Capsules in Healthy Men
5 de agosto de 2020 actualizado por: Ixchelsis Limited
A Randomised, Single-dose, 3-way Crossover Study to Evaluate the Relative Bioavailability of the IX-01 Capsule Formulation Compared With the IX-01 Aqueous Dispersion Formulation, and the Effect of Food on the IX-01 Capsule Formulation, in Healthy Male Subjects
The purpose of this study is to compare the absorption and blood levels of IX-01 when given as a capsule compared to liquid form, and how food affects the absorption in healthy men.
Descripción general del estudio
Tipo de estudio
Intervencionista
Inscripción (Actual)
12
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
-
-
-
London, Reino Unido
- Hammersmith Medicines Research
-
-
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 a 45 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Masculino
Descripción
Inclusion Criteria:
- A body mass index (Quetelet index) in the range 18-30 kilograms/meters squared (kg/m2)
- Body Mass Index = weight [kg] divided by (height [m])2
- Total body weight greater than (>)50 kg at screening
- Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of, the entire trial
- Participants and their partners must be willing to use adequate forms of contraception and to comply with the contraception requirements during the trial and for 4 months after the last dose of medication
- Willingness to give written consent to have data entered into The Over Volunteering Prevention System
Exclusion Criteria:
Clinically relevant abnormal history, physical findings, ECG, or laboratory values at the pre-trial screening assessment, including:
- Lipid and/or liver function test results >1.25 x Upper Limit of Normal (ULN) or other clinical laboratory blood biochemistry test results outside the normal reference range unless discussed and approved by sponsor
- International normalised ratio (INR) of >1.2 or a platelet count < 150 x 109/Liter
- History of unexplained syncope
- Family history of unexplained sudden death, or sudden death due to long QT syndrome
- Fridericia Correction Formula (QTcF) interval >450 milliseconds (msec) at screening
- Bundle branch block and other conduction abnormalities, other than mild first degree atrio-ventricular block
- Irregular rhythms other than sinus arrhythmia or occasional supraventricular ectopic beats
- T-wave configuration of insufficient quality for determination of QT interval, as assessed by the investigator
- Presence of acute or chronic illness or history of chronic illness sufficient to invalidate participation in the trial
- Impaired gastrointestinal, endocrine, thyroid, hepatic, cardiovascular, respiratory, haematological, renal or neurological function, diabetes mellitus, coronary heart disease, or history of any psychotic mental illness
- Surgery (for example (e.g.) stomach bypass) or medical condition that might affect absorption, metabolism or elimination of medicines
- Any skin condition, abnormality of the lumbar spine, medical or surgical condition that would preclude lumbar puncture (e.g. coagulopathy, local or systemic infection, left ventricular outflow obstruction, aortic stenosis, previous back surgery)
- Presence or history of severe adverse reaction to any drug
- Use of any prescription or over-the-counter medicine during the 14 days before the first dose of trial medication, or intention to use any medicine during the trial, with the exception of short courses of medication considered by the investigator not to interfere with the safety of the participant or the integrity of the trial data (such as acetaminophen (paracetamol))
- Current use of any herbal remedy or nutritional supplement, or intention to use any such product during the study
- Participation in another clinical trial of a new chemical entity or a prescription medicine within the previous 3 months.
- Previous participation in this trial or any other clinical trial of an oxytocin receptor antagonist
- Presence or history of drug or alcohol abuse, or intake of more than 21 units of alcohol weekly or more than 5 cigarettes daily
- Blood pressure and heart rate in supine position at the screening examination outside the ranges 100-130 millimeters of mercury (mm Hg) systolic, 60-90 mm Hg diastolic; heart rate 50-100 beats/minute. Measurements must be made in duplicate, and all values must fall within the acceptable ranges
- Possibility that the participant will not cooperate with the requirements of the protocol
- Evidence of drug abuse on urine testing
- Positive test for hepatitis B, hepatitis C, Human Immunodeficiency Virus 1 (HIV1) or Human Immunodeficiency Virus 2 (HIV2)
- Loss of more than 400 mL blood during the 3 months before the trial, e.g. as a blood donor
- Objection by General Practitioner (GP), on medical grounds, to participant entering trial
- Employee of the investigator site or any company involved in sponsoring, organizing or conducting the trial, or immediate family of the employee
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: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: IX-01 Capsule while Fasting
Singe oral dose of 800 milligrams of IX-01 as a capsule, while fasting, in 1 of 3 treatment periods
|
|
Experimental: IX-01 Aqueous Dispersion while Fasting
Single oral dose of 800 milligrams IX-01 as an aqueous dispersion, while fasting in 1 of 3 treatment periods
|
|
Experimental: IX-01 Capsule after Food
Single oral dose of 800 milligrams IX-01 as a capsule, after food, in 1 of 3 treatment periods
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Relative Bioavailability (Frel) of a Capsule Compared to a Liquid Formulation of IX-01 While Fasting, as Calculated by a Ratio of Area Under the Plasma Concentration Time Curve From Time 0 to Infinity
Periodo de tiempo: Pre-dose up to 96 hours post dose
|
Pre-dose up to 96 hours post dose
|
|
Relative Bioavailability (Frel) of a Capsule Formulation of IX-01 in the Fed State Compared to the Fasted State, as Calculated by a Ratio of Area Under the Plasma Concentration Time Curve From Time 0 to Infinity
Periodo de tiempo: Pre-dose up to 96 hours post dose
|
Pre-dose up to 96 hours post dose
|
|
Relative Bioavailability (Frel) of a Capsule Compared With a Liquid Formulation of IX-01 While Fasting, as Calculated by a Ratio of Peak Plasma Concentrations
Periodo de tiempo: Pre-dose up to 96 hours post dose
|
Pre-dose up to 96 hours post dose
|
|
Relative Bioavailability (Frel) of a Capsule Formulation of IX-01 in a Fed State Compared to a Fasted State, as Calculated by a Ratio of Peak Plasma Concentrations
Periodo de tiempo: Pre-dose up to 96 hours post dose
|
Pre-dose up to 96 hours post dose
|
|
Area Under the Plasma Concentration Time Curve From Time 0 to Infinity, Following a Single Dose of IX-01
Periodo de tiempo: Pre-dose and up to 96 hours post dose
|
Pre-dose and up to 96 hours post dose
|
|
Peak Plasma Concentration (Cmax) of IX-01
Periodo de tiempo: Pre-dose and up to 96 hours post dose
|
Pre-dose and up to 96 hours post dose
|
|
Time to Peak Plasma Concentration (Tmax) of IX-01
Periodo de tiempo: Pre-dose up to 96 hours post dose
|
Pre-dose up to 96 hours post dose
|
|
Elimination Half Life (t1/2) of IX-01
Periodo de tiempo: Pre-dose up to 96 hours post dose
|
Pre-dose up to 96 hours post dose
|
|
Elimination Rate Constant (Kel) of IX-01
Periodo de tiempo: Pre-dose up to 96 hours post last dose
|
Pre-dose up to 96 hours post last dose
|
|
Area Under the Plasma Concentration Time Curve From Time 0 to the Time of the Last Measurable Sample of IX-01
Periodo de tiempo: Pre-dose to the time of the last measurable sample
|
Pre-dose to the time of the last measurable sample
|
|
Concentration of IX-01 in Cerebrospinal Fluid (CSF) After a Single Dose of the Liquid Formulation of IX-01
Periodo de tiempo: 1, 2, 4 and 6 hours after dosing
|
Listed by time point of 1, 2, 4, 6 hours post dose
|
1, 2, 4 and 6 hours after dosing
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs
Periodo de tiempo: Baseline to study completion (approximately 6 weeks)
|
Baseline to study completion (approximately 6 weeks)
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Email: Ixchelsis@Choruspharma.com, Ixchelsis Limited
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 mayo de 2014
Finalización primaria (Actual)
1 de junio de 2014
Finalización del estudio (Actual)
1 de junio de 2014
Fechas de registro del estudio
Enviado por primera vez
12 de mayo de 2014
Primero enviado que cumplió con los criterios de control de calidad
13 de mayo de 2014
Publicado por primera vez (Estimar)
15 de mayo de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
20 de agosto de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
5 de agosto de 2020
Última verificación
1 de agosto de 2020
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- IX-0102
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. .
Ensayos clínicos sobre IX-01
-
Ixchelsis LimitedTerminado
-
Ixchelsis LimitedHealthCore-NERI; Novotech (Australia) Pty Limited; ICON plc; PHT CorporationTerminadoEyaculación precozEstados Unidos, Australia
-
Ixchelsis LimitedTerminadoVoluntarios SaludablesReino Unido
-
Ixchelsis LimitedTerminado
-
Ixchelsis LimitedTerminado
-
Bioverativ Therapeutics Inc.Swedish Orphan BiovitrumTerminadoHemofilia B severaSuecia, Estados Unidos, Francia, Italia, Federación Rusa, Reino Unido, Alemania, Porcelana, Polonia, Japón, Australia, Brasil, Canadá, India, Sudáfrica, Hong Kong, Bélgica
-
Imperial College LondonTerminadoClaudicación intermitente | Enfermedad vascular periférica | Enfermedad Arterial de las Extremidades InferioresReino Unido
-
Imperial College LondonActegy Ltd.TerminadoVenas varicosas | Insuficiencia venosa | EdemaReino Unido
-
Baxalta now part of ShireBaxalta Innovations GmbH, now part of ShireTerminado