GLPG3067 ( DrugBank: - )


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2

299. 嚢胞性線維症


臨床試験数 : 1,696 薬物数 : 1,644 - (DrugBank : 272) / 標的遺伝子数 : 96 - 標的パスウェイ数 : 170
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-000098-61-GB
(EUCTR)
22/06/201801/06/2018A study to evaluate the efficacy, safety, tolerability and pharmacokinetics of the combination of GLPG3067, GLPG2222 and GLPG2737 in adult patients with cystic fibrosisA Phase II, randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy, safety, tolerability and pharmacokinetics of orally administered combination of GLPG3067, GLPG2222 and GLPG2737, in adult subjects with cystic fibrosis homozygous or heterozygous for F508del CFTR Cystic Fibrosis
MedDRA version: 20.0;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: GLPG3067
Product Code: G914167
INN or Proposed INN: Not applicable
Other descriptive name: GLPG3067
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2222
Product Name: GLPG2737
Product Code: G1117337
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2737
Product Name: GLPG2737
Product Code: G1117337
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2737
Galapagos NVNULLNot Recruiting Female: yes
Male: yes
144 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;France;United States;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;New Zealand;United Kingdom
2NCT03589313
(ClinicalTrials.gov)
February 12, 20189/7/2018Pharmacokinetics of GLPG3067 in Male Subjects With Cystic Fibrosis.Evaluation of the Pharmacokinetics, Safety and Tolerability of a Single Dose of GLPG3067 Administered as Solid Formulation in Male Subjects With Cystic Fibrosis.Cystic FibrosisDrug: GLPG3067 single doseGalapagos NVNULLCompleted18 YearsN/AMale6Phase 1Belgium