DDrare: Database of Drug Development for Rare Diseases

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	1

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT01910415 (ClinicalTrials.gov)	June 2013	19/7/2013	Phase 1, QT/QTC Interval Study in Healthy Subjects	A Phase 1, Randomized, Placebo and Active Controlled, Double-Blind, Parallel, Electrocardiogram Study to Evaluate the Effect of Lumacaftor in Combination With Ivacaftor on the QT/QTc Interval in Healthy Subjects	Cystic Fibrosis	Drug: Lumacaftor;Drug: Lumacaftor Placebo;Drug: Ivacaftor;Drug: Ivacaftor Placebo;Drug: moxifloxacin hydrochloride	Vertex Pharmaceuticals Incorporated	NULL	Completed	18 Years	55 Years	Both	200	Phase 1	Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT01910415
(ClinicalTrials.gov)

June 2013

19/7/2013

Phase 1, QT/QTC Interval Study in Healthy Subjects

A Phase 1, Randomized, Placebo and Active Controlled, Double-Blind, Parallel, Electrocardiogram Study to Evaluate the Effect of Lumacaftor in Combination With Ivacaftor on the QT/QTc Interval in Healthy Subjects

Cystic Fibrosis

Drug: Lumacaftor;Drug: Lumacaftor Placebo;Drug: Ivacaftor;Drug: Ivacaftor Placebo;Drug: moxifloxacin hydrochloride

Vertex Pharmaceuticals Incorporated

NULL

Completed

18 Years

55 Years

Both

200

Phase 1

Netherlands