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A Single-center, Randomized, Blinded, Placebo-controlled Two-part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Selective Androgen Receptor Modulator (SARM), GSK2849466, in Single and Repeat Doses, With and Without Food, in Healthy Male Subjects

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

GSK2849466

+ Placebo

+ GSK2849466

Medicamento
Quiénes están siendo reclutados

Peso Corporal+4

+ Cambios en el Peso Corporal

+ Signos y Síntomas

De 18 a 50 años
+26 Criterios de eligibilidad
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Otro tipo de estudio

Fase 1
Intervencional
Inicio del estudio: septiembre de 2012
Ver detalles del protocolo

Resumen

Patrocinador PrincipalGlaxoSmithKline
Última actualización: 7 de junio de 2017
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 26 de septiembre de 2012

Fecha en la que se inscribió al primer participante.

This study is the first administration of GSK2849466 in humans. This will be a single centre, randomized, double-blind, placebo-controlled study, to investigate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GSK2849466, given as single and repeat oral doses up to 14 days to healthy male subjects. Part A will be a randomized placebo controlled and 4-way crossover study. It will include two cohorts of 8 subjects each. In each cohort there will be 4 study periods each approximately of 1 week including 6 days of washout. Each subject will receive a total of 3 active doses as ascending single oral dose of GSK2849466 and 1 placebo dose during the course of their participation in the study. The first ("bridging dose") dose provided to subjects in Cohort 2 will be the same as the last dose provided to subjects in Cohort 1. The single doses of GSK2849466 planned in Part A of this study are: 0.01, 0.03, 0.1, and 0.3 milligram (mg) in Cohort 1 and 0.3, 1, 3, and 10 mg in Cohort 2. In cohorts 1 and 2 all available safety, tolerability, and PK data will be reviewed prior to each dose escalation. The dosing schedule in Part A may be adjusted to expand a cohort or to add an additional cohort(s) in order to further evaluate additional doses or repeat evaluation of a dose level already studied. Part B will be a randomized placebo controlled, parallel group study. It will include three cohorts of 12 subjects each. Each subject will receive repeat doses of GSK2849466 over 14 days. The doses chosen for Part B will be based on the safety, tolerability, and PK data from Part A. Subjects in Cohort 4 (and/or an another cohort [s] as determined based on Part A PK data) will be dosed in the fasted state on Days 1 and 14 and in the fed state on Day 7 when subjects will receive a standard meal 30 minutes prior to dosing. Part B will provide sufficient safety and tolerability data to bridge to longer duration studies. The study duration, including screening and follow-up, is not expected to exceed 70 days for subjects in the study.

NCT01696604
Patrocinador PrincipalGlaxoSmithKline
Última actualización: 7 de junio de 2017
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 17 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Otro Tipo de Estudio

Algunos estudios exploran temas que no encajan en una categoría específica. Pueden incluir investigaciones innovadoras, nuevas tecnologías o áreas emergentes en el ámbito de la salud.

Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Hombre

Sexo biológico de los participantes elegibles para inscribirse.

De 18 a 50 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

Peso CorporalCambios en el Peso CorporalSignos y SíntomasCondiciones Patológicas, Signos y SíntomasDelgadezPérdida de pesoCaquexia

Criterios

6 criterios de inclusión requeridos para participar
Average corrected QT interval using Fridericia's formulas (QTcF) < 450 milliseconds (msec); or QTcF < 480 msec in subjects with Bundle Branch Block
Body weight >= 50 kilogram (kg) and Body Mass Index (BMI) within the range 19 - 32 kg/meter (m)^2 (inclusive), where BMI = (weight in kg)/(height in meters)^2
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GlaxoSmithKline (GSK) Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures
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20 criterios de exclusión impiden participar
A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
A positive pre-study drug or alcohol screen
A positive test for human immunodeficiency virus (HIV) antibody
Cotinine levels indicative of smoking or history or regular use of tobacco-or nicotine-containing products within 6 months prior to screening
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Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

10 grupos de intervención están designados en este estudio

0% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Experimental
The subjects will receive single planned dose of GSK284946 in ascending order (0.01, 0.03, 0.1, and 0.3 mg) in ratio of 3:1.with placebo within each of 4 treatment periods. The dose will not be allowed to exceed 30 mg over a 24-hour period.

Grupo II

Experimental
The subjects will receive single dose of matching placebo in one of the 4 treatment periods.

Grupo III

Experimental
The subjects will receive single planned dose of GSK284946 in ascending order (0.3, 1, 3, and 10 mg) in ratio of 3:1.with placebo within each of 4 treatment periods. The dose will not be allowed to exceed 30 mg over a 24-hour period in one of the 4 treatment periods.

Grupo IV

Experimental
The subjects will receive single dose of matching placebo in one of the 4 treatment periods.

Grupo 5

Experimental
The selection of appropriate doses for Part B will be performed upon consideration of available safety and tolerability and PK data from Part A and/or any preceding repeat dose cohorts. The subjects will receive GSK2849466 in ratio of 3:1.with placebo.

Grupo 6

Experimental
The subjects will receive repeat dose of matching placebo.

Grupo 7

Experimental
The selection of appropriate doses for Part B will be performed upon consideration of available safety and tolerability and PK data from Part A and/or any preceding repeat dose cohorts. The subjects will receive GSK2849466 in ratio of 3:1.with placebo. In Cohort 4 subjects will be dosed in the fasted state on Days 1 and 14 and in the fed state on Day 7.

Grupo 8

Experimental
The subjects will receive repeat doses of matching placebo.

Grupo 9

Experimental
The selection of appropriate doses for Part B will be performed upon consideration of available safety and tolerability and PK data from Part A and/or any preceding repeat dose cohorts. The subjects will receive GSK2849466 in ratio of 3:1.with placebo

Grupo 10

Experimental
The subjects will receive repeat doses of matching placebo.

Objetivos 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

GSK Investigational Site

Baltimore, United StatesAbrir GSK Investigational Site en Google Maps
Completado1 Centros de Estudio