- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07636928
Mass Balance and Absolute Oral Bioavailability of [14C]VH4524184
29 de junio de 2026 actualizado por: ViiV Healthcare
A Phase 1, Open-Label, Single Dose Study to Assess the Absolute Bioavailability, Mass Balance, Pharmacokinetics, Metabolism, and Excretion of [14C]VH4524184 in Healthy Participants
The purpose of the study is to assess the bioavailability, mass balance, pharmacokinetics, metabolism and excretion of radiolabeled (14C) VH4524184.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
9
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.
Estudio Contacto
- Nombre: US GSK Clinical Trials Call Center
- Número de teléfono: 877-379-3718
- Correo electrónico: GSKClinicalSupportHD@gsk.com
Copia de seguridad de contactos de estudio
- Nombre: EU GSK Clinical Trials Call Center
- Número de teléfono: +44 (0) 20 89904466
- Correo electrónico: GSKClinicalSupportHD@gsk.com
Ubicaciones de estudio
-
-
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Groningen, Países Bajos, 9728 NZ
- Reclutamiento
- GSK Investigational Site
-
Contacto:
- US GSK Clinical Trials Call Center
- Número de teléfono: 877-379-3718
- Correo electrónico: GSKClinicalSupportHD@gsk.com
-
Contacto:
- EU GSK Clinical Trials Call Centre
- Número de teléfono: +44 (0) 20 8990 4466
- Correo electrónico: GSKClinicalSupportHD@gsk.com
-
Investigador principal:
- Renger Tiessen
-
-
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
- Adulto
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
- Willing and able to sign the Informed Consent Form (ICF).
- Sex at birth: male or female; female participants must be of non-childbearing potential, or postmenopausal.
- Age: 18 to 55 years, inclusive, at screening.
- BMI: 18.0 to 32.0 kg/m^2, inclusive, at screening.
- Female participants of non-childbearing potential must have unequivocal documentation that they are not of childbearing potential Postmenopausal female participants must have a serum follicle-stimulating hormone (FSH) concentration >33.4 milli-international units per milliliter (mIU/mL) at screening to confirm menopause.
- Male participants, if not surgically sterilized and who have a female partner of childbearing potential, must agree to use a condom during any sexual intercourse until the completion of the follow-up visit.
- Male participants must agree not to donate sperm from admission on Day -1 until the completion of the follow-up visit.
- All prescribed medication must have been stopped at least 30 days and >5 half-lives prior to admission to the clinical site on Day -1.
- All over-the-counter medication, vitamin preparations and other food supplements, or herbal medications must have been stopped at least 14 days prior to admission to the clinical site on Day -1. An exception is made for paracetamol that is allowed up to admission to the clinical site on Day -1.
- Ability and willingness to abstain from alcohol from 48 hours prior to screening and admission to the clinical site on Day -1 until the last PK sample.
- Ability and willingness to abstain from methylxanthine-containing beverages or food (coffee, black tea, green tea, white tea, cola, chocolate, energy drinks), and grapefruit (juice) from 48 hours prior to admission to the clinical site.
- Good physical and mental health based on medical history, physical examination, clinical laboratory, electrocardiogram (ECG), and vital signs, as judged by the Investigator.
Exclusion Criteria:
- Employee of ICON, the Sponsor, GSK or associated vendors.
- History of relevant drug and/or food allergies.
- History of drug hypersensitivity, delayed-type hypersensitivity, or severe hypersensitivity reactions, as well as history of sensitivity to the study drug.
- Using tobacco/nicotine products within 60 days prior to the first study drug administration.
- History of alcohol abuse or drug addiction within 5 years prior to screening.
- Positive drug and/or alcohol screen at screening or admission to the clinical site.
- Average intake of more than 24 units of alcohol per week.
- Positive screen for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (HIV) 1 and 2 antibodies at screening.
- Participation in a drug study with a small molecule drug within 30 days or 5 half-lives if known (whichever is longer) prior to the first study drug administration in the current study. Participation in a clinical study with a biological within 90 days or 5 half-lives if known (whichever is longer) prior to the first study drug administration in the current study. Participation in 4 or more other drug studies in the 12 months prior to the first study drug administration in the current study.
- Donation or loss of more than 450 mL of blood within 60 days prior to the first study drug administration. Donation or loss of more than 1.5 L of blood (for male participants)/more than 1.0 L of blood (for female participants) in the 10 months prior to the first study drug administration in the current study.
- Significant and/or acute illness within 14 days prior to the first study drug administration that may impact safety assessments, in the opinion of the Investigator.
- Any significant current/ongoing known or suspected pre-existing psychiatric condition, including depression, anxiety, and/or insomnia/sleep disturbances and/or suicidal ideation, in the opinion of the Investigator.
- Unsuitable veins for infusion or blood sampling.
- Participation in a study with a 14C dose of ≥0.1 megabecquerel (MBq) in the period of 1 year prior to screening.
- Irregular defecation pattern.
- Pre-existing clinically relevant, in the opinion of the Investigator in discussion with the Sponsor medical monitor, gastro-intestinal pathology or diagnosis, eg, irritable bowel syndrome, inflammatory bowel disease, and/or significant baseline signs and symptoms.
- History or presence of clinical condition or disorder that could be capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study drugs, interfering with the interpretation of data or would make the participant unsuitable for the study; unable to comply with dosing requirements; or unable to comply with study visits, in the opinion of the Investigator. The Investigator may contact the Sponsor medical monitor to discuss the inclusion of participants who have a history of specific conditions that are not expected to interfere with their participation in the study.
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: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: VH4524184 Group
Participants will receive a dose of VH4524184 under fasting conditions, followed by a microdose of radiolabelled [14C]VH4524184 administered 2.5 hours after first dose administration at time zero on Day 1 (Period1).
After a 14 days wash-out period participants will receive a radiolabelled dose of [14C]VH4524184 on Day 15 under fasting conditions.
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One dose of VH4524184 is administered to participants at time zero on Day 1 (Period 1).
A radiolabelled microdose of [14C]VH4524184 is administered 2.5 hours after VH4524184 dose administration on Day 1 (Period1).
One dose of radiolabelled [14C]VH4524184 is administered to participants at Day 15 (Period 2).
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Absolute bioavailability (F oral) of VH4524184 (Period 1)
Periodo de tiempo: Day 1 up to Day 14
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Day 1 up to Day 14
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Amount of total radioactivity (TRA) excreted in urine (Ae urine) (Period 1)
Periodo de tiempo: Day 1 up to Day 14
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Urine is collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and <1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is <1% on 2 consecutive days).
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Day 1 up to Day 14
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Amount of TRA excreted in urine (Ae urine) (Period 2)
Periodo de tiempo: Day 15 up to Day 43
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Urine is collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and <1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is <1% on 2 consecutive days).
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Day 15 up to Day 43
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Amount of TRA excreted in feces (Ae feces) (Period 1)
Periodo de tiempo: Day 1 up to Day 14
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Feces are collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and <1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is <1% on 2 consecutive days).
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Day 1 up to Day 14
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Amount of TRA excreted in feces (Ae feces) (Period 2)
Periodo de tiempo: Day 15 up to Day 43
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Feces are collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and <1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is <1% on 2 consecutive days).
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Day 15 up to Day 43
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Amount of TRA excreted in vomitus (Ae vomit) (Period 1)
Periodo de tiempo: At Day 1
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At Day 1
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Amount of TRA excreted in vomitus (Ae vomit) (Period 2)
Periodo de tiempo: At Day 15
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At Day 15
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Total amount of TRA excreted (Ae total) (Period 1)
Periodo de tiempo: From Day 1 up to Day 14
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The Ae of TRA measured in urine, feces and vomitus (if applicable on Day 1 only).
Urine and feces are collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and <1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is <1% on 2 consecutive days).
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From Day 1 up to Day 14
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Total amount of TRA excreted (Ae total) (Period 2)
Periodo de tiempo: Day 15 up to Day 43
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The Ae of TRA measured in urine, feces and vomitus (if applicable on Day 15 only).
Urine and feces are collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and <1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is <1% on 2 consecutive days).
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Day 15 up to Day 43
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Fraction of TRA excreted in urine (fe urine) (Period 1)
Periodo de tiempo: Day 1 up to Day 14
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Urine is collected until the amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and <1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is <1% on 2 consecutive days).
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Day 1 up to Day 14
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Fraction of TRA excreted in urine (fe urine) (Period 2)
Periodo de tiempo: Day 15 up to Day 43
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Urine is collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and <1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is <1% on 2 consecutive days).
|
Day 15 up to Day 43
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Fraction of TRA excreted in feces (fe feces) (Period 1)
Periodo de tiempo: Day 1 up to Day 14
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Feces is collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and <1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is <1% on 2 consecutive days).
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Day 1 up to Day 14
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Fraction of TRA excreted in feces (fe feces) (Period 2)
Periodo de tiempo: Day 15 up to Day 43
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Feces is collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and <1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is <1% on 2 consecutive days).
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Day 15 up to Day 43
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Fraction of TRA excreted in vomitus (fe vomit) (Period 1)
Periodo de tiempo: At Day 1
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At Day 1
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Fraction of TRA excreted in vomitus (fe vomit) (Period 2)
Periodo de tiempo: At Day 15
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At Day 15
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Total fraction of TRA excreted (fe total) (Period 1)
Periodo de tiempo: Day 1 up to Day 14
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The fe of TRA measured in urine, feces and vomitus (if applicable on Day 1 only).
Urine and feces are collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and <1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is <1% on 2 consecutive days).
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Day 1 up to Day 14
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Total fraction of TRA excreted (fe total) (Period 2)
Periodo de tiempo: Day 15 up to Day 43
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The fe of TRA measured in urine, feces and vomitus (if applicable on Day 15 only).
Urine and feces are collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and <1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is <1% on 2 consecutive days).
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Day 15 up to Day 43
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Maximum concentration (Cmax) of VH4524184 in plasma (Period 1)
Periodo de tiempo: Day 1 to Day 14
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Day 1 to Day 14
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Maximum concentration (Cmax) of VH4524184 in plasma (Period 2)
Periodo de tiempo: Day 15 to Day 43
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Day 15 to Day 43
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Maximum concentration (Cmax) of [14C]VH4524184 in plasma (Period 1)
Periodo de tiempo: Day 1 to Day 14
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Day 1 to Day 14
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Maximum concentration (Cmax) of TRA in plasma (Period 1)
Periodo de tiempo: Day 1 to Day 14
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Day 1 to Day 14
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Maximum concentration (Cmax) of TRA in plasma (Period 2)
Periodo de tiempo: Day 15 to Day 43
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Day 15 to Day 43
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Cmax of TRA in whole blood (Period 1)
Periodo de tiempo: Day 1 to Day 14
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Day 1 to Day 14
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Cmax of TRA in whole blood (Period 2)
Periodo de tiempo: Day 15 to Day 43
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Day 15 to Day 43
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Time to maximum concentration (tmax) of VH4524184 in plasma (Period 1)
Periodo de tiempo: Day 1 to Day 14
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Day 1 to Day 14
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Time to maximum concentration (tmax) of VH4524184 in plasma (Period 2)
Periodo de tiempo: Day 15 to Day 43
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Day 15 to Day 43
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Time to maximum concentration (tmax) of [14C]VH4524184 in plasma (Period 1)
Periodo de tiempo: Day 1 to Day 14
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Day 1 to Day 14
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Time to maximum concentration (tmax) of TRA in plasma (Period 1)
Periodo de tiempo: Day 1 to Day 14
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Day 1 to Day 14
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Time to maximum concentration (tmax) of TRA in plasma (Period 2)
Periodo de tiempo: Day 15 to Day 43
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Day 15 to Day 43
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Time to maximum concentration (tmax) of TRA in whole blood (Period 1)
Periodo de tiempo: Day 1 to Day 14
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Day 1 to Day 14
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Time to maximum concentration (tmax) of TRA in whole blood (Period 2)
Periodo de tiempo: Day 15 to Day 43
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Day 15 to Day 43
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Area under the concentration-time curve from time zero to the last measured timepoint (AUC 0-t) of VH4524184 in plasma (Period 1)
Periodo de tiempo: Day 1 to Day 14
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Day 1 to Day 14
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Area under the concentration-time curve from time zero to the last measured timepoint (AUC 0-t) of VH4524184 in plasma (Period 2)
Periodo de tiempo: Day 15 to Day 43
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Day 15 to Day 43
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Area under the concentration-time curve from time zero to the last measured timepoint (AUC 0-t) of [14C]VH4524184 in plasma (Period 1)
Periodo de tiempo: Day 1 to Day 14
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Day 1 to Day 14
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Area under the concentration-time curve from time zero to the last measured timepoint (AUC 0-t) of TRA in plasma (Period 1)
Periodo de tiempo: Day 1 to Day 14
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Day 1 to Day 14
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Area under the concentration-time curve from time zero to the last measured timepoint (AUC 0-t) of TRA in plasma (Period 2)
Periodo de tiempo: Day 15 to Day 43
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Day 15 to Day 43
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Area under the concentration-time curve from time zero to the last measured timepoint (AUC 0-t) of TRA in whole blood (Period 1)
Periodo de tiempo: Day 1 to Day 14
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Day 1 to Day 14
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Area under the concentration-time curve from time zero to the last measured timepoint (AUC 0-t) of TRA in whole blood (Period 2)
Periodo de tiempo: Day 15 to Day 43
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Day 15 to Day 43
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Area under the concentration-time curve from time zero to infinity (AUC 0-inf) of VH4524184 in plasma (Period 1)
Periodo de tiempo: Day 1 to Day 14
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Day 1 to Day 14
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Area under the concentration-time curve from time zero to infinity (AUC 0-inf) of VH4524184 in plasma (Period 2)
Periodo de tiempo: Day 15 up to Day 43
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Day 15 up to Day 43
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Area under the concentration-time curve from time zero to infinity (AUC 0-inf) of [14C]VH4524184 in plasma (Period 1)
Periodo de tiempo: Day 1 to Day 14
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Day 1 to Day 14
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Area under the concentration-time curve from time zero to infinity (AUC 0-inf) of TRA in plasma (Period 1)
Periodo de tiempo: Day 1 to Day 14
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Day 1 to Day 14
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Area under the concentration-time curve from time zero to infinity (AUC 0-inf) of TRA in plasma (Period 2)
Periodo de tiempo: Day 15 to 43
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Day 15 to 43
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Area under the concentration-time curve from time zero to infinity (AUC 0-inf) of TRA in whole blood (Period 1)
Periodo de tiempo: Day 1 to Day 14
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Day 1 to Day 14
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Area under the concentration-time curve from time zero to infinity (AUC 0-inf) of TRA in whole blood (Period 2)
Periodo de tiempo: Day 15 to Day 43
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Day 15 to Day 43
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Amount of VH4524184 excreted in urine (Ae urine) (Period 2)
Periodo de tiempo: Day 15 to Day 43
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Day 15 to Day 43
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Fraction of VH4524184 excreted in urine (fe urine) (Period 2)
Periodo de tiempo: Day 15 to Day 43
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Day 15 to Day 43
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Renal clearance of VH4524184 (CL R) (Period 2)
Periodo de tiempo: Day 15 to Day 43
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Day 15 to Day 43
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of participants with adverse events (AE), overall and by severity (Periods 1 and 2)
Periodo de tiempo: Day 1 to Day 50
|
Day 1 to Day 50
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Number of participants who discontinue treatment due to AEs (Periods 1 and 2)
Periodo de tiempo: Day 1 to Day 50
|
Day 1 to Day 50
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Change from baseline for aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, and alkaline phosphatase (Periods 1 and 2)
Periodo de tiempo: On Days 2, 14, 16, 28 and 42
|
On Days 2, 14, 16, 28 and 42
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Maximum toxicity grade increase from baseline for AST, ALT, total bilirubin, and alkaline phosphatase (Periods 1 and 2)
Periodo de tiempo: On Days 2, 14, 16, 28 and 42
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On Days 2, 14, 16, 28 and 42
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Blood to plasma ratio of TRA (Periods 1 and 2)
Periodo de tiempo: Day 1 to Day 14 (Period 1) and Day 15 to Day 28 (Period 2)
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Cmax, AUC(0-t) and AUC(0-inf) TRA measured in whole blood compared to Cmax, AUC(0-t) and AUC(0-inf) TRA measured in plasma in Period 1 and Period 2.
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Day 1 to Day 14 (Period 1) and Day 15 to Day 28 (Period 2)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 (Actual)
4 de junio de 2026
Finalización primaria (Estimado)
20 de agosto de 2026
Finalización del estudio (Estimado)
20 de agosto de 2026
Fechas de registro del estudio
Enviado por primera vez
29 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
3 de junio de 2026
Publicado por primera vez (Actual)
9 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
2 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
29 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Infecciones transmitidas por la sangre
- Enfermedades urogenitales
- Enfermedades Genitales
- Enfermedades del sistema inmunológico
- Infecciones
- Infecciones por virus de ARN
- Enfermedades virales
- Enfermedades contagiosas
- Enfermedades De Transmisión Sexual Virales
- Enfermedades de transmisión sexual
- Infecciones por lentivirus
- Infecciones por retroviridae
- Síndromes de deficiencia inmunológica
- Enfermedades de virus lentos
- Infecciones por VIH
- Síndrome de inmunodeficiencia adquirida
Otros números de identificación del estudio
- 223803
- 2026-525590-40 (Otro identificador: EU CT Number)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents.
Data sharing is subject to certain criteria, conditions, and exceptions.
For further information, refer to https://www.viiv-studyregister.com/documents/About_ViiV_Patient_Level_Data_Sharing_Final_25Sep2023.pdf
Marco de tiempo para compartir IPD
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
Criterios de acceso compartido de IPD
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place.
Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
Sí
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. .