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Principal Investigator: 

Damian Downey

 

Name of the Study:

A Phase ½ Study to Evaluate the Safety, tolerability , and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in adults with Cystic Fibrosis

 

Short name: PTI-808-01

        

Why is this important?

 

Previous studies have shown that altering CF at the cell level (CFTR) can significantly reduce symptoms and improve lung function.

 

What is the Research question/aim?

This trial is exploring the safety and tolerability of the co-administration of PTI-808 (CFTR potentiator), PTU-808 (CFTR corrector) + PTI-428 (CFTR amplifier) in patients with Cystic Fibrosis with the F508del/F508del in genotype.

 

This study is placebo controlled, meaning that some participants will receive the study drug, and others will receive a placebo. Both the participants and study team will be blinded to whether the participant is receiving the study drug or placebo.

 

 

What the Study involves: 

It involved 10 visits over approximately 2 months

 

Who can take part in the Study?

Patients with cystic fibrosis, aged over 18 years, with the F508del/F508del genotype

 

Contact Information:

Principal Investigator:

Dr Damian Downey

BHSCT/QUB

Respiratory Research Office

Ground Floor

Tower Block

Belfast City Hospital

 

02895043902

damian.downey@beflasttrust.hscni.net

 

 

 

Study Coordinator:

Esther Ramsay

Respiratory Research Office

Ground Floor

Tower Block

Belfast City Hospital

02895043902

esther.ramsay@belfasttrut.hscni.net

 

 

Location:

NI Clinical Research Facility,

U Floor, Belfast City Hospital,

Lisburn Road, Belfast, BT9 7AB

 

Tel:+44 (0)28 9504 0342

Email:NICRF@qub.ac.uk

 
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