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A study of 2 CFTR modulators in people with cystic fibrosis (FDL169 & FDL176)

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

Open to recruitment

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, Drug-Drug Interaction Study of FDL169 and FDL176 in Healthy Subjects and in Cystic Fibrosis Subjects Homozygous for the F508del-CFTR Mutation

In this study investigational CFTR modulators called FDL169 and FDL176 will be studied when given in combination. FDL169 is an oral medication that improves the function of the protein that is defective in Cystic Fibrosis (the CFTR protein), a type of compound known as a CFTR corrector. FDL169 is planned as a long-term treatment of CF in people who have the genetic mutation known as F508del-CFTR mutation. FDL176 is an oral medication that aims to improve the function of the protein that is defective in Cystic Fibrosis (CF) (the CFTR protein), a type of compound known as a CFTR potentiator. The aim of this trial is to study how well FDL169 and FDL176 are tolerated by people with CF when given in combination. In addition, the trial will study how the medications move around the body, and how they are absorbed and digested. For this purpose, the amount of FDL169 and FDL176 will be measured in your blood at specific intervals after you take the tablet orally (this is called pharmacokinetics [PK]). The impact on your CF will also be measured with tests for sweat chloride and changes in lung volumes, measured by spirometry tests.

Trial Reference Number

125691

Trial type

Medication

Intervention
the name of the treatment or therapy being researched

FDL169 and FDL176

Last edited date

29 October 2019

CF sponsor

Flatley Discovery Lab LLC

CF sponsor type

Commercial

Who can take part?

Age

18+

Top inclusion criteria
  • Body mass index of 18.0 to 32.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator
Top exclusion criteria
  • Presence or history of clinically significant allergy requiring treatment, as judged by the investigator
  • Participation in another clinical trial involving receipt of an IMP within the past 90 days

CF centres running this trial

Recruiting

Celerion Research Institute

Address

22-24 Lisburn Rd Belfast BT9 6AD

Recruitment ends

November 2019

Contact

,

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Recruiting

Nottingham University Hospitals NHS Trust

Address

City Hospital campus Hucknall Road Nottingham Nottinghamshire NG7 2UH

Recruitment ends

December 2019

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Recruiting

Royal Brompton Hospital

Address

Sydney Street London SW3 6NP

Recruitment ends

December 2019

Contact

Simmonds, Nicholas

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Recruiting

Western General Hospital

Address

Crewe Road South Edinburgh EH4 2XU

Recruitment ends

December 2019

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