A Study to Assess various doses of an ENaC inhibitor medication (mucociliary clearance) in Healthy Volunteers and People with Cystic Fibrosis

Details

Therapeutic approach
Mucociliary Clearance
Trial status
Closed with results Participating Centres
Trials Tracker ID
TT002031
Last updated
06/04/2020

Full title

A phase 1/2a study to assess various doses of an ENaC inhibitor medication called ION-827359 in Healthy Volunteers and People With Cystic Fibrosis

Study details

A study medication called ION-827359 is being developed to treat lung disease symptoms in people with cystic fibrosis. The study medication is intended to help treat the thick mucus found in the airways of patients with cystic fibrosis.



This new inhaled (nebulized) medication will be investigated in both people with, and without cystic fibrosis. The study will compare the study medication with a placebo (a solution that looks identical to the study medication but contains no active ingredients), which means some participants will receive the study medication, whilst others will receive the placebo. Participants won’t know whether they are receiving the study medication or the placebo.



Participation in the study lasts for approximately 21 weeks (just over 5 months), and will require numerous visits to complete study assessments (blood tests, questionnaires, lung function etc.) to the recruitment centre.


Phase
Phase 2a
CF sponsor
Ionis Pharmaceuticals
CF sponsor type
Commercial

Who can take part?

Age range
18 years and older
Including people

Confirmed diagnosis of CF
Weight >40Kg
FEV1 >/= 50% of predicted

Excluding people

Respiratory infection within 4 weeks of Study Day 1

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CF centres running this trial

Closed

Belfast - Celerion Research Institute

CTAP centre
NHS Trust
Belfast Health & Social Care Trust
Address
22-24 Lisburn Road
BT9 6AD
Recruitment starts
Recruitment ends
Local site investigator
Stuart Elborn
Trial Coordinators
Catherine McNeill
Closed

Edinburgh - Western General Hospital (Adults)

CTAP centre
NHS Trust
NHS Lothian
Address
Crewe Road South
EH4 2XU
Trial Coordinators
Ellyse Kilarski
Closed

King's College Hospital (London)

CTAP centre
NHS Trust
King's College Hospital NHS Foundation Trust
Address
King's College Hospital
Denmark Hill
SE5 9RS
Recruitment starts
Recruitment ends
Local site investigator
Michael Waller
Trial Coordinators
Mélanie Le Sayec
Closed

Manchester - Medicines Evaluation Unit

CTAP centre
NHS Trust
Manchester University NHS Foundation Trust
Address
The Langley Building
Southmoor Road, Wythenshawe
M23 9QZ
Recruitment ends
Trial Coordinators
Sarah Sampson