A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Repeat Doses of GSK2586184 and the Effect of Food and Gender — JAK116439

Systemic Lupus Erythematosus Clinical Trial

Official title:
A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK2586184 Following a Single Doseof 800mg and Repeat Oral Tablet Doses of 800mg b.d and the Effect of Food and Gender on the Pharmacokinetics of oralGSK2586184 in Healthy Subjects

Status Completed

Clinical Trial Summary

A study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and repeat doses of 800 mg GSK2586184 in healthy subjects.

Clinical Trial Description

This is a study in healthy volunteers to investigate the safety, tolerability, pharmacokinetics (the body's effect on the drug) and pharmacodynamics (the drug's effect on the body) of single and repeat doses of 800 mg GSK2586184. The effect of food and gender on pharmacokinetics will also be investigated following single dosing.

The study is made up of 2 groups of healthy subjects. The first group consists of 6 female subjects who will receive a single dose of 800mg GSK2586184 (study medication) during 2 seperate sessions. One session will involve the female subjects taking the study medication with food and the other session will involve study medication being taken without food. The safety and tolerability of the study medication in female subjects and the effect of food on the pharmacokinetics of the study medication will be investigated.

The second group will consist of 12 healthy male subjects participating in 2 sessions. 8 subjects will receive study medication and 4 will receive placebo (dummy medication) during the course of the study. Neither they or their study doctor will know which one they are given. Each male subject will receive a single dose of study medication or placebo followed by 13 days of twice daily dosing of study medication or placebo. Each dose will be taken with food.The single dose results from this group of subjects will be compared to the female group to investigate the effect of gender on pharmacokinetics. The safety and pharmacokinetics of repeat dosing will be investigated. The effect of repeat dosing on kidney function and the immune system will also be investigated.

The study will take place in the SGS Clinical Pharmacology Unit in Antwerp, Belgium. A pharmaceutical company, GlaxoSmithKline, is funding the study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01687309
Study type	Interventional
Source	GlaxoSmithKline
Contact
Status	Completed
Phase	Phase 1
Start date	April 30, 2012
Completion date	July 31, 2012

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT03843125` - A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE)	Phase 3
Recruiting	`NCT05698173` - Systemic Lupus Erythematosus and Accelerated Aging	N/A
Active, not recruiting	`NCT01649765` - Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy	Phase 2
Recruiting	`NCT05704153` - Modelling and Control of Non-invasive Vagus Nerve Stimulation for Autoimmune Diseases (1A)	N/A
Completed	`NCT05048238` - Evaluation of Tofacitinib in Prevention of Photosensitivity in Lupus	Phase 1
Recruiting	`NCT06056778` - The Prevalence Evaluation of Systemic Lupus Erythematosus in Russian Patients With Reproductive Issues (PRISMA)
Completed	`NCT04358302` - Individual Patient Exposure and Response in Pediatric Lupus	N/A
Completed	`NCT03802578` - The Impact of Exercise on Hand Function, Daily Activities Performance and Quality of Life of SLE' Patients	N/A
Completed	`NCT02554019` - Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus Erythematosus	Phase 2
Recruiting	`NCT04835883` - Exploring the Efficacy and Safety of CS20AT04 (Allogenic Bone Marrow-Derived Stem Cell) in Systemic Lupus Erythematosus Patients	Phase 2
Terminated	`NCT02665364` - Phase IIb Study of IFN-K in Systemic Lupus Erythematosus	Phase 2
Completed	`NCT00278538` - Cyclophosphamide and Rabbit Antithymocyte Globulin (rATG)/Rituximab in Patients With Systemic Lupus Erythematosus	Phase 2
Completed	`NCT00069342` - Health Beliefs and Health Behaviors Among Minorities With Rheumatic Diseases
Completed	`NCT03252587` - An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus Erythematosus	Phase 2
Terminated	`NCT02066311` - Nelfinavir in Systemic Lupus Erythematosus	Phase 2
Recruiting	`NCT01892748` - Cholecalciferol Supplementation on Disease Activity, Fatigue and Bone Mass on Juvenile Systemic Lupus Erythematosus.	N/A
Terminated	`NCT01689025` - An Investigation of Safety and Tolerability of NNC0114-0006 in Subjects With Systemic Lupus Erythematosus (SLE)	Phase 1
Completed	`NCT01475149` - Effect of HCQ on AnxA5 Resistance Assay in Antiphospholipid (aPL) Positive Patients With and Without Systemic Lupus Erythematosus (SLE)	N/A
Unknown status	`NCT01712529` - Physical Exercise, Endothelial Function and Progenitor Endothelial Cells in Systemic Lupus Erythematosus Patients	N/A
Completed	`NCT00962832` - A Study to Evaluate the Efficacy and Safety of Rontalizumab in Patients With Moderately to Severely Active Systemic Lupus Erythematosus	Phase 2