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	NCT02976519 (ClinicalTrials.gov)	February 15, 2017	25/11/2016	BI 443651 Multiple Rising Dose in Healthy Volunteers Followed by a Cross-over in CF Subjects	A Phase Ib, Multicentre, Double Blind, Randomized, Two-part Study, First Part Multiple Rising Dose and Second Part Two-way Cross-over, to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of BI 443651 Compared to Placebo Via Respimat® in Healthy Volunteers and CF Subjects.	Cystic Fibrosis	Drug: BI 443651;Drug: Placebo	Boehringer Ingelheim	NULL	Completed	18 Years	55 Years	All	64	Phase 1	Germany;United Kingdom

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

NCT02976519
(ClinicalTrials.gov)

February 15, 2017

25/11/2016

BI 443651 Multiple Rising Dose in Healthy Volunteers Followed by a Cross-over in CF Subjects

A Phase Ib, Multicentre, Double Blind, Randomized, Two-part Study, First Part Multiple Rising Dose and Second Part Two-way Cross-over, to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of BI 443651 Compared to Placebo Via Respimat® in Healthy Volunteers and CF Subjects.

Cystic Fibrosis

Drug: BI 443651;Drug: Placebo

Boehringer Ingelheim

NULL

Completed

18 Years

55 Years

All

Phase 1

Germany;United Kingdom