Efecto de los alimentos en la farmacocinética de Camlipixant en participantes sanos
Este estudio tiene como objetivo evaluar cómo el consumo de alimentos afecta la absorción y el procesamiento del fármaco Camlipixant en voluntarios sanos.
GSK5464714- Camlipixant
Tos+3
+ Trastornos de la respiración
+ Enfermedades del Tracto Respiratorio
Estudio de Tratamiento
Resumen
Fecha de inicio: 9 de julio de 2024
Fecha en la que se inscribió al primer participante.Este ensayo clínico tiene como objetivo comprender cómo los alimentos afectan la manera en que el cuerpo absorbe y procesa un medicamento llamado Camlipixant (GSK5464714). El estudio está dirigido a hombres y mujeres sanos para recopilar información inicial sobre el comportamiento del fármaco en el cuerpo. Comprender la influencia de los alimentos es importante, ya que puede afectar la eficacia y la seguridad del medicamento. Esta información es crucial para desarrollar pautas sobre cómo debe tomarse el medicamento en relación con las comidas. Los participantes en el estudio recibirán una sola dosis de Camlipixant y serán asignados a diferentes secuencias para comparar los efectos con y sin alimentos. El estudio utiliza un diseño de etiqueta abierta, lo que significa que tanto los investigadores como los participantes saben qué tratamiento se está administrando. Habrá un mínimo de un descanso de 7 días entre cada período de tratamiento para asegurar que el fármaco se haya eliminado completamente del cuerpo antes de la siguiente secuencia. Este estudio ayuda a recopilar datos fundamentales que podrían llevar a mejores recomendaciones de dosificación para futuros pacientes.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 14 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 18 a 55 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: * Participants who are healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, clinical laboratory tests, vital sign measurements, and 12-lead ECGs including the following: * Seated blood pressure (after 5 mins), average of 3 readings, is greater than or equal to (\>=) 90/55 millimetre of mercury (mmHg) and less than or equal (\<=)140/90 mmHg at the screening visit. * Seated heart rate, average of 3 readings, is \>= 40 beats per minutes (bpm) and \<= 99 bpm at the screening visit. * Corrected QT interval using the Fridericia formula (QTcF) on ECG, average of 3 readings, is \<= 450 millisecond (msec) and 12-lead ECG findings considered normal or not clinically significant by the investigator or designee at the screening visit. * Aspartate transferase (AST), Alanine transaminase (ALT), direct bilirubin, indirect bilirubin, and total bilirubin within normal ranges at the screening visit and check-in. Only abnormal values up to 1.5 x upper limit of normal may be repeated once * Continuous non-smoker who has never used nicotine- or tobacco-containing products or light smoker for the last 6 months prior to study screening * Body weight ≥ 50.0 kilogram (kg) and Body mass index (BMI) within the range 18.5 to 32.0 kilogram per meter square (kg/m2) (inclusive) at Screening. * Male and female participants must follow protocol-specified contraception guidance. * Female participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies * Is a woman of nonchildbearing potential (WONCBP) * Is a Woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective * A WOCBP must have a negative highly sensitive serum pregnancy test within 24 hours before the first dose of study intervention (i.e., Day -1 of each treatment period) * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. * Must be willing and able to comply with the protocol. Exclusion Criteria: * History or presence of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, biliary (including gallstones or previous cholecystectomy), endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data. * Have a history of malignant neoplasm (excepting definitively treated non melanoma skin cancer or carcinoma in situ of the uterine cervix, which may be enrolled at any time) within the last 5 years. * Past or intended use of over-the-counter or prescription medication including herbal medications within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to dosing. * Participation in the clinical study would result in loss of blood or blood products in excess of 500 milliliter (mL) within 3 months. * Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day. * Current enrolment or past participation in another investigational clinical study in which an investigational intervention (e.g., drug, vaccine, invasive device) was administered within the last 30 days or 5.5 half-lives before signing of consent in any other clinical study involving an investigational study intervention or any other type of medical research. * Current enrolment or past participation in this clinical study. * Positive pre-study drug/alcohol screen, including tetrahydrocannabinol. * Positive Human immunodeficiency virus (HIV) antibody test. * Positive coronavirus (severe acute respiratory syndrome coronavirus 2 \[SARS-CoV-2\]) polymerase chain reaction test at check-in. * Presence of Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb) at screening or within 3 months prior to first dose of study intervention. * Positive Hepatitis C virus (HCV) antibody test result at screening or within 3 months prior to starting study intervention. * Total bilirubin \>1.5x upper limit of normal (ULN), including participants with Gilbert's syndrome. * Regular alcohol consumption within 6 months prior to the clinical study defined as: For sites in United States of America (USA), an average weekly intake of 3 units for males or 1.5 units for females. * History of known drugs of abuse, including tetrahydrocannabinol, in last 5 years. * Sensitivity to heparin or heparin-induced thrombocytopenia. * Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the clinical study. * Use of any products intended to treat medical conditions that are not approved by the governing health authority in a given country or region (for example, herbal medicine, health supplements, traditional medicine, homeopathic remedies, etc.), within past 30 days prior to signing the consent and during the study. * Any dietary restrictions that would prevent the participant from consuming the site menu/meals.
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalGrupo II
ExperimentalObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación