GSK2586184 ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
49全身性エリテマトーデス11

49. 全身性エリテマトーデス


臨床試験数 : 993 薬物数 : 702 - (DrugBank : 184) / 標的遺伝子数 : 116 - 標的パスウェイ数 : 200
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01953835
(ClinicalTrials.gov)
October 4, 201326/9/2013A Two-part Study to Investigate the Interaction and Pharmacokinetics of GSK2586184A Two-part Healthy Volunteer Study to Investigate Both the Interaction of GSK2586184 With Rosuvastatin and Simvastatin and to Compare the Pharmacokinetics of Two Different Formulations of GSK2586184Systemic Lupus ErythematosusDrug: GSK2586184 standard formulation;Drug: Simvastatin;Drug: Rosuvastatin;Drug: GSK2586184 new formulationGlaxoSmithKlineNULLCompleted18 Years65 YearsAll37Phase 1United States
2EUCTR2012-001645-41-CZ
(EUCTR)
15/04/201305/12/2012A study to assess the efficacy and safety of GSK2586184 in SLEAn adaptive Phase II study to evaluate the efficacy, pharmacodynamics, safety and tolerability of GSK2586184 in patients with active systemic lupus erythematosus. Systemic Lupus Erythematosus
MedDRA version: 16.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]
Product Name: GSK2586184
Product Code: GSK2586184
INN or Proposed INN: GSK2586184
Other descriptive name: N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide
Product Name: GSK2586184
Product Code: GSK2586184
INN or Proposed INN: GSK2586184
Other descriptive name: N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
250Phase 2Estonia;Hong Kong;Greece;Spain;Thailand;Chile;Russian Federation;India;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Peru;South Africa;Germany;Sweden;Korea, Republic of
3EUCTR2012-001645-41-PL
(EUCTR)
14/03/201320/12/2012A study to assess the efficacy and safety of GSK2586184 in SLEAn adaptive Phase II study to evaluate the efficacy, pharmacodynamics, safety and tolerability of GSK2586184 in patients with active systemic lupus erythematosus. Systemic Lupus Erythematosus
MedDRA version: 16.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]
Product Name: GSK2586184
Product Code: GSK2586184
INN or Proposed INN: GSK2586184
Other descriptive name: N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide
Product Name: GSK2586184
Product Code: GSK2586184
INN or Proposed INN: GSK2586184
Other descriptive name: N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide
GlaxoSmithKline Research and Development LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 2Hong Kong;Estonia;Greece;Thailand;Spain;Chile;Russian Federation;Italy;India;France;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Romania;Peru;South Africa;Germany;Korea, Republic of;Sweden
4NCT01777256
(ClinicalTrials.gov)
March 1, 201324/1/2013An Adaptive Phase II Study to Evaluate the Efficacy, Pharmacodynamics, Safety and Tolerability of GSK2586184An Adaptive Phase II Study to Evaluate the Efficacy, Pharmacodynamics, Safety and Tolerability of GSK2586184 in Patients With Mild to Moderate Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: GSK2586184 50 mg;Drug: GSK2586184 100 mg;Drug: GSK2586184 200 mg;Drug: GSK2586184 400 mg;Drug: PlaceboGlaxoSmithKlineNULLTerminated18 Years75 YearsAll51Phase 2Argentina;Chile;Czechia;Estonia;France;Germany;Greece;Hong Kong;Hungary;Korea, Republic of;Peru;Poland;Romania;South Africa;Spain;Sweden;Brazil;Czech Republic
5EUCTR2012-001645-41-DE
(EUCTR)
19/02/201316/10/2012A study to assess the efficacy and safety of GSK2586184 in SLEAn adaptive Phase II study to evaluate the efficacy, pharmacodynamics, safety and tolerability of GSK2586184 in patients with active systemic lupus erythematosus. Systemic Lupus Erythematosus
MedDRA version: 16.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]
Product Name: GSK2586184
Product Code: GSK2586184
INN or Proposed INN: GSK2586184
Other descriptive name: N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide
Product Name: GSK2586184
Product Code: GSK2586184
INN or Proposed INN: GSK2586184
Other descriptive name: N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
250Phase 2India;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Peru;South Africa;Germany;Sweden;Korea, Republic of;Thailand;Russian Federation;Chile;Estonia;Hong Kong;Greece;Spain
6EUCTR2012-001645-41-SE
(EUCTR)
15/02/201329/10/2012A study to assess the efficacy and safety of GSK2586184 in SLEAn adaptive Phase II study to evaluate the efficacy, pharmacodynamics, safety and tolerability of GSK2586184 in patients with mild to moderate systemic lupus erythematosus. Systemic Lupus Erythematosus
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]
Product Name: GSK2586184
Product Code: GSK2586184
INN or Proposed INN: GSK2586184
Other descriptive name: N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide
Product Name: GSK2586184
Product Code: GSK2586184
INN or Proposed INN: GSK2586184
Other descriptive name: N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
250Phase 2Estonia;Hong Kong;Greece;Spain;Thailand;Russian Federation;Chile;India;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Peru;South Africa;Germany;Sweden;Korea, Republic of
7EUCTR2012-001645-41-EE
(EUCTR)
28/12/201227/11/2012A study to assess the efficacy and safety of GSK2586184 in SLEAn adaptive Phase II study to evaluate the efficacy, pharmacodynamics, safety and tolerability of GSK2586184 in patients with active systemic lupus erythematosus. Systemic Lupus Erythematosus
MedDRA version: 16.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]
Product Name: GSK2586184
Product Code: GSK2586184
INN or Proposed INN: GSK2586184
Other descriptive name: N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide
Product Name: GSK2586184
Product Code: GSK2586184
INN or Proposed INN: GSK2586184
Other descriptive name: N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
250Phase 2Estonia;Hong Kong;Greece;Spain;Chile;Czech Republic;Hungary;Argentina;Poland;Brazil;Peru;South Africa;Germany;Korea, Republic of;Sweden
8EUCTR2012-001645-41-ES
(EUCTR)
19/12/201212/11/2012A study to assess the efficacy and safety of GSK2586184 in SLEAn adaptive Phase II study to evaluate the efficacy, pharmacodynamics, safety and tolerability of GSK2586184 in patients with mild to moderate systemic lupus erythematosus. Systemic Lupus Erythematosus
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]
Product Name: GSK2586184
Product Code: GSK2586184
INN or Proposed INN: GSK2586184
Other descriptive name: N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide
Product Name: GSK2586184
Product Code: GSK2586184
INN or Proposed INN: GSK2586184
Other descriptive name: N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide
GlaxoSmithKline, S.A.NULLNot RecruitingFemale: yes
Male: yes
250Phase 2Estonia;Hong Kong;Greece;Spain;Thailand;Russian Federation;Chile;India;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Peru;South Africa;Germany;Sweden;Korea, Republic of
9EUCTR2012-001645-41-HU
(EUCTR)
13/12/201224/10/2012A study to assess the efficacy and safety of GSK2586184 in SLEAn adaptive Phase II study to evaluate the efficacy, pharmacodynamics, safety and tolerability of GSK2586184 in patients with mild to moderate systemic lupus erythematosus. Systemic Lupus Erythematosus
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]
Product Name: GSK2586184
Product Code: GSK2586184
INN or Proposed INN: GSK2586184
Other descriptive name: N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide
Product Name: GSK2586184
Product Code: GSK2586184
INN or Proposed INN: GSK2586184
Other descriptive name: N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
250Phase 2Estonia;Hong Kong;Greece;Spain;Thailand;Russian Federation;Chile;India;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Peru;South Africa;Germany;Sweden;Korea, Republic of
10EUCTR2012-001645-41-GR
(EUCTR)
11/12/201213/11/2012A study to assess the efficacy and safety of GSK2586184 in SLEAn adaptive Phase II study to evaluate the efficacy, pharmacodynamics, safety and tolerability of GSK2586184 in patients with mild to moderate systemic lupus erythematosus. Systemic Lupus Erythematosus
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]
Product Name: GSK2586184
Product Code: GSK2586184
INN or Proposed INN: GSK2586184
Other descriptive name: N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide
Product Name: GSK2586184
Product Code: GSK2586184
INN or Proposed INN: GSK2586184
Other descriptive name: N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
250Phase 2Estonia;Hong Kong;Greece;Spain;Thailand;Russian Federation;Chile;India;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Peru;South Africa;Germany;Sweden;Korea, Republic of
11NCT01687309
(ClinicalTrials.gov)
April 30, 201210/5/2012A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Repeat Doses of GSK2586184 and the Effect of Food and GenderA 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 SubjectsSystemic Lupus ErythematosusDrug: GSK2586184 800mg single and repeat dose;Drug: Placebo-to-match GSK2586184;Other: GSK2586184 single dose taken with food;Other: GSK2586184 single dose taken without foodGlaxoSmithKlineNULLCompleted18 Years65 YearsAll19Phase 1Belgium