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A Study to Evaluate Safety and Pharmacokinetics of VX-659 in Healthy Subjects and in Adults With Cystic Fibrosis

Details

Therapeutic category
the type of treatment or therapy being studied. A therapy could range from a medication addressing a particular characteristic of CF to a device or activity e.g. exercise

Restore CFTR Function

Trial status

Archived

Participating Centres
Phase
the different stages involved in the development of a new medication. Phase I focuses on initial safety in people. Phase 2 evaluates safety, correct dose and early signs of whether the medication works. Phase 3 is the stage before medication licensing and looks at safety and medication effectiveness. Phase 4 evaluates longer term use of a medication after it has been licensed for use

Phase I

Full title

A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose Escalation, and Bioavailability Study Evaluating the Safety and Pharmacokinetics of VX-659 in Healthy Subjects and in Subjects With Cystic Fibrosis

Evaluate the safety and tolerability of VX-659 in healthy subjects

Trial Reference Number

88595

Trial type

Medication

Length of participation
the length of time a participant will take part in a trial, from the first to the last appointment

6 months

Intervention
the name of the treatment or therapy being researched

CFTR Modulators

Recruitment target
the number of participants who need to be recruited for the trial in the UK

12

Last edited date

05 June 2018

CF sponsor

Vertex Pharmaceuticals Incorporated

CF sponsor type

Commercial

Who can take part?

Mutation

One copy of F508del

Age

18+

Top inclusion criteria
  • Age 18 years or older
  • Heterozygous for F508del and a minimal function CFTR mutation
  • FEV1 ≥ 40% and ≤ 90% of predicted normal for age, sex, and height
  • Sweat chloride value ≥ 60 mmol/L at screening
Top exclusion criteria
  • History of cirrhosis with portal hypertension
  • Risk factors for Torsade de Pointes (abnormal hears rhythm)
  • History of hemolysis

CF centres running this trial

Closed

Heart of England NHS Foundation Trust

Address

Birmingham Heartlands Hospital Bordesley Green East Birmingham West Midlands B9 5SS

Recruitment starts

March 2017

Recruitment ends

June 2017

Contact

Nash, Edward

Get in touch

Closed

Liverpool Heart and Chest Hospitals NHS Foundation Trust

Address

Thomas Drive Liverpool Merseyside L14 3PE

Recruitment starts

March 2017

Recruitment ends

July 2017

Contact

Ledson, Martin

Get in touch

Closed

Papworth Hospital NHS Foundation Trust

Address

Papworth Hall Papworth Everard Cambridge Cambridgeshire CB23 3RE

Recruitment starts

March 2017

Recruitment ends

April 2017

Contact

Haworth, Charles

Get in touch

Closed

Royal Brompton and Harefield NHS Foundation Trust

Address

Royal Brompton Hospital Sydney Street London Greater London SW3 6NP

Recruitment starts

March 2017

Contact

Davies, Jane C

Get in touch
Show all participating centres