Who is sponsoring NCT01687309?

NCT01687309 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT01687309?

Interventions in NCT01687309: GSK2586184 800mg single and repeat dose, Placebo-to-match GSK2586184, GSK2586184 single dose taken with food, GSK2586184 single dose taken without food.

What condition does NCT01687309 study?

NCT01687309 studies Systemic Lupus Erythematosus.

Is NCT01687309 still recruiting?

NCT01687309 is currently completed. Last updated 25 May 2018.

Last reviewed 2018-05-25 · How we verify

NCT01687309: JAK116439

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 25 May 2018

What this trial tests

Phase 1 trial testing GSK2586184 800mg single and repeat dose in Systemic Lupus Erythematosus in 19 participants. Completed in 31 July 2012.

Timeline

30 April 2012

Primary endpoint
31 July 2012

31 July 2012

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	19
Start date	30 April 2012
Primary completion	31 July 2012
Estimated completion	31 July 2012
Sites	1 location across Belgium

Drugs / interventions tested

GSK2586184 800mg single and repeat dose — full drug profile →
Placebo-to-match GSK2586184 — full drug profile →
GSK2586184 single dose taken with food
GSK2586184 single dose taken without food

Conditions studied

Systemic Lupus Erythematosus — all drugs for Systemic Lupus Erythematosus →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 65, any sex, with Systemic Lupus Erythematosus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Type I/II cytokines, JAKs, and new strategies for treating autoimmune diseases.
Schwartz DM, Bonelli M, Gadina M, O'Shea JJ. · · 2016 · cited 474× · PMID 26633291 · DOI 10.1038/nrrheum.2015.167
JAK inhibition as a therapeutic strategy for immune and inflammatory diseases.
Schwartz DM, Kanno Y, Villarino A, Ward M, et al · · 2017 · cited 308× · PMID 29282366 · DOI 10.1038/nrd.2017.267
The arrival of JAK inhibitors: advancing the treatment of immune and hematologic disorders.
Furumoto Y, Gadina M. · · 2013 · cited 73× · PMID 23743669 · DOI 10.1007/s40259-013-0040-7
Signaling Pathways of Type I and Type III Interferons and Targeted Therapies in Systemic Lupus Erythematosus.
Chyuan IT, Tzeng HT, Chen JY. · · 2019 · cited 62× · PMID 31450787 · DOI 10.3390/cells8090963

Verify or expand the search:

Other recruiting trials for Systemic Lupus Erythematosus

Currently open trials in the same condition.

NCT06984341 — A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Pharmacodynamics, and Efficacy of P-CD19CD20-ALLO1 in P · Phase 1 · recruiting
NCT07526350 — MTS109 in Patients With Refractory Autoimmune Diseases · EARLY_PHASE1 · recruiting
NCT07246096 — Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Rel · EARLY_PHASE1 · recruiting
NCT07363590 — A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004) · Phase 1 · recruiting
NCT07371468 — A Study of GSK5926371 in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD) · Phase 1 · recruiting

Other GlaxoSmithKline trials

Trials by the same sponsor.

NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam · Phase 2, PHASE3 · not yet recruiting
NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · Phase 1 · not yet recruiting
NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01687309 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 25 May 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01687309.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing