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A Phase 1/2 Study of VX-121 in Subjects With Cystic Fibrosis and in Subjects without Cystic Fibrosis (VX17-121-001)

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

Closed to recruitment - in follow up

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/II

Full title

A Phase 1/2 Study of VX-121 in Healthy Subjects and in Subjects With Cystic Fibrosis

The purpose of this study is to evaluate safety and tolerability of VX-121 in healthy subjects and in subjects with cystic fibrosis.

Trial Reference Number

111537

Trial type

Medication

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

132

Last edited date

19 March 2019

CF sponsor

Vertex Pharmaceuticals Incorporated

CF sponsor type

Commercial

Who can take part?

Mutation

One copy of F508del

Age

18+

Top inclusion criteria
  • Body weight ≥35 kg
  • Must be able to produce a valid (quantity-sufficient) sweat sample at screening.
  • Heterozygous for F508del and an MF mutation
Top exclusion criteria
  • Any condition possibly affecting drug absorption
  • History of clinically significant cirrhosis with or without portal hypertension

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

December 2018

Recruitment ends

February 2019

Contact

Nash, Edward

Get in touch

Closed

Medicines Evaluation Unit

Address

The Langley Building Southmoor Road Wythenshawe Manchester M23 9QZ

Contact

Horsley, Alexander

Get in touch