GLPG1837 ( DrugBank: GLPG-1837 )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
299嚢胞性線維症8

299. 嚢胞性線維症


臨床試験数 : 1,695 薬物数 : 1,527 - (DrugBank : 268) / 標的遺伝子数 : 111 - 標的パスウェイ数 : 174
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
1EUCTR2015-003291-77-DE
(EUCTR)
25/05/201611/11/2015A study looking at the safety of the drug GLPG1837 in patients with cystic fibrosis and the G551D mutationA phase IIa, open label study of multiple doses of GLPG1837 in subjects with cystic fibrosis and the G551D mutation Cystic fibrosis with the G551D mutation
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837
Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837
Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
32Phase 2Czech Republic;Ireland;Australia;Germany;United Kingdom
2EUCTR2015-003292-30-NL
(EUCTR)
26/02/201602/12/2015A study looking at the safety of the drug GLPG1837 in patients with cysticfibrosis and the S1251N mutationA phase IIa, open-label study of two doses of GLPG1837 in subjects with cystic fibrosis and the S1251N mutation. Cystic fibrosis with the S1251N mutation
MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837
Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
6Phase 2Belgium;Netherlands
3EUCTR2015-003291-77-IE
(EUCTR)
03/02/201603/12/2015A study looking at the safety of the drug GLPG1837 in patients with cystic fibrosis and the G551D mutationA phase IIa, open label study of multiple doses of GLPG1837 in subjects with cystic fibrosis and the G551D mutation Cystic fibrosis with the G551D mutation
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837
Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837
Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
32Phase 2Czech Republic;Ireland;Australia;Germany;United Kingdom
4EUCTR2015-003291-77-GB
(EUCTR)
02/02/201603/11/2015A study looking at the safety of the drug GLPG1837 in patients with cystic fibrosis and the G551D mutationA phase IIa, open label study of multiple doses of GLPG1837 in subjects with cystic fibrosis and the G551D mutation Cystic fibrosis with the G551D mutation
MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837
Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837
Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837
Galapagos NVNULLNot Recruiting Female: yes
Male: yes
32 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noCzech Republic;Ireland;Australia;Germany;United Kingdom
5NCT02707562
(ClinicalTrials.gov)
February 201622/2/2016Study of GLPG1837 in Subjects With Cystic Fibrosis (G551D Mutation)A Phase IIa, Open-label Study of Multiple Doses of GLPG1837 in Subjects With Cystic Fibrosis and the G551D MutationCystic FibrosisDrug: GLPG1837 dose 1;Drug: GLPG1837 dose 2;Drug: GLPG1837 dose 3Galapagos NVNULLCompleted18 YearsN/ABoth26Phase 2Australia;Czech Republic;Germany;Ireland;United Kingdom
6EUCTR2015-003291-77-CZ
(EUCTR)
26/01/201616/11/2015A study looking at the safety of the drug GLPG1837 in patients with cystic fibrosis and the G551D mutationA phase IIa, open label study of multiple doses of GLPG1837 in subjects with cystic fibrosis and the G551D mutation Cystic fibrosis with the G551D mutation
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837
Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837
Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
32Phase 2Czech Republic;Ireland;Australia;Germany;United Kingdom
7EUCTR2015-003292-30-BE
(EUCTR)
18/01/201626/11/2015A study looking at the safety of the drug GLPG1837 in patients with cysticfibrosis and the S1251N mutationA phase IIa, open-label study of two doses of GLPG1837 in subjects with cystic fibrosis and the S1251N mutation. Cystic fibrosis with the S1251N mutation
MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837
Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
6Phase 2Belgium;Netherlands
8NCT02690519
(ClinicalTrials.gov)
January 201616/2/2016Study of GLPG1837 in Subjects With Cystic Fibrosis (S1251N Mutation)A Phase IIa, Open-label Study of Two Doses of GLPG1837 in Subjects With Cystic Fibrosis and the S1251N MutationCystic FibrosisDrug: GLPG1837 dose 1;Drug: GLPG1837 dose 2Galapagos NVNULLCompleted18 YearsN/ABoth7Phase 2Belgium;Netherlands