PTI-801 ( DrugBank: PTI-801 )


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6

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_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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agemax
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PhaseCountries
1EUCTR2017-003319-21-BE
(EUCTR)
08/11/201821/08/2018Study Assessing the Safety, Tolerability and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in Adults with Cystic FibrosisA Phase 1 / 2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in Adults with Cystic Fibrosis 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: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: N-(5-hydroxy-2,4-bis(trimethylsilyl)phenyl)-4-oxo-1,4-dihydroquinoline-3-carboxamide
Product Code: PTI-808
INN or Proposed INN: None
Other descriptive name: PTI-808
Product Name: Sodium (R)-8-methyl-2-(3-methylbenzofuran-2-yl)-5-(1-(tetrahydro-2H-pyran-4-yl)ethoxy)quinoline-4-ca
Product Code: PTI-801
INN or Proposed INN: None
Other descriptive name: PTI-801
Product Name: N-(trans-3-(5-((R)-1-hydroxyethyl)-1,3,4-oxadiazol-2-yl)cyclobutyl)-3-phenylisoxazole-5-carboxamide
Product Code: PTI-428
INN or Proposed INN: None
Other descriptive name: PTI-428
Proteostasis Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
240Phase 1;Phase 2United States;France;Canada;Belgium;Denmark;Germany;United Kingdom
2EUCTR2017-003319-21-DE
(EUCTR)
20/07/201809/04/2018Study Assessing the Safety, Tolerability and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in Adults with Cystic FibrosisA Phase 1 / 2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in Adults with Cystic Fibrosis 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: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Sodium (R)-8-methyl-2-(3-methylbenzofuran-2-yl)-5-(1-(tetrahydro-2H-pyran-4-yl)ethoxy)quinoline-4-ca
Product Code: PTI-801
INN or Proposed INN: None
Other descriptive name: PTI-801
Product Name: N-(5-hydroxy-2,4- bis(trimethylsilyl)phenyl)-4-oxo- 1,4-dihydroquinoline-3-carboxamide
Product Code: PTI-808
INN or Proposed INN: None
Other descriptive name: PTI-808
Product Name: N-(5-hydroxy-2,4- bis(trimethylsilyl)phenyl)-4-oxo- 1,4-dihydroquinoline-3-carboxamide
Product Code: PTI-808
INN or Proposed INN: None
Other descriptive name: PTI-808
Product Name: N-(trans-3-(5-((R)-1-hydroxyethyl)-1,3,4-oxadiazol-2-yl)cyclobutyl)-3-phenylisoxazole-5-carboxamide
Product Code: PTI-428
INN or Proposed INN: None
Other descriptive name: PTI-428
Proteostasis Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
240Phase 1;Phase 2United States;France;Canada;Belgium;Denmark;Germany;United Kingdom
3EUCTR2017-003319-21-GB
(EUCTR)
04/06/201803/07/2018Study Assessing the Safety, Tolerability and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in Adults with Cystic FibrosisA Phase 1 / 2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in Adults with Cystic Fibrosis 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: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: N-(5-hydroxy-2,4-bis(trimethylsilyl)phenyl)-4-oxo-1,4-dihydroquinoline-3-carboxamide
Product Code: PTI-808
INN or Proposed INN: None
Other descriptive name: PTI-808
Product Name: Sodium (R)-8-methyl-2-(3-methylbenzofuran-2-yl)-5-(1-(tetrahydro-2H-pyran-4-yl)ethoxy)quinoline-4-ca
Product Code: PTI-801
INN or Proposed INN: None
Other descriptive name: PTI-801
Product Name: N-(trans-3-(5-((R)-1-hydroxyethyl)-1,3,4-oxadiazol-2-yl)cyclobutyl)-3-phenylisoxazole-5-carboxamide
Product Code: PTI-428
INN or Proposed INN: None
Other descriptive name: PTI-428
Proteostasis Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
240Phase 1;Phase 2France;United States;Canada;Belgium;Denmark;Germany;United Kingdom
4NCT03500263
(ClinicalTrials.gov)
January 30, 20189/4/2018Safety, Tolerability, and Pharmacokinetics of PTI-808, PTI-801, and PTI-428 Combination Therapy in Subjects With Cystic FibrosisA Phase 1 / 2, Randomized, Double-Blind, Placebo-Controlled Study Designed to Evaluate the Safety, Tolerability, and Pharmacokinetics of PTI-808, PTI-801, and PTI-428 Combination Therapy in Subjects With Cystic FibrosisCystic FibrosisDrug: PTI-808;Drug: Placebo;Drug: PTI-801;Drug: PTI-428Proteostasis Therapeutics, Inc.NULLCompleted18 YearsN/AAll12Phase 1/Phase 2United Kingdom
5NCT03251092
(ClinicalTrials.gov)
July 17, 20177/8/2017Study Designed to Assess the Safety, Tolerability and PK of PTI-808 in Healthy Volunteers and in Adults With Cystic FibrosisA Phase 1/2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in Adults With Cystic FibrosisHealthy Volunteer - Complete;Cystic Fibrosis - CompleteDrug: PTI-808;Drug: Placebo;Drug: PTI-428;Drug: PTI-801Proteostasis Therapeutics, Inc.NULLCompleted18 Years99 YearsAll179Phase 1/Phase 2United States;Australia;Belgium;Canada;Denmark;France;Germany;New Zealand;United Kingdom
6NCT03140527
(ClinicalTrials.gov)
April 10, 201727/4/2017Study Assessing the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interactions of PTI-801 in Healthy Volunteers, and Safety, Tolerability, and Pharmacokinetics of PTI-801 in Subjects With Cystic FibrosisA Multi-Center, Randomized, Placebo-Controlled, Phase 1, Two-Part Study Designed to Assess the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interactions of PTI-801 in Healthy Volunteers, and Safety, Tolerability, and Pharmacokinetics of PTI-801 in Subjects With Cystic FibrosisHealthy Volunteer;Cystic FibrosisDrug: PTI-801;Drug: Placebo;Drug: PTI-808Proteostasis Therapeutics, Inc.NULLCompleted18 YearsN/AAll171Phase 1United States;Canada;Denmark;Germany;Sweden;Portugal