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Study to Evaluate Safety, Pharmacokinetics and Pharmacodynamics of FDL169 in 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

Open

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 Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate Safety, Pharmacokinetics and Pharmacodynamics of FDL169 in Cystic Fibrosis Subjects Homozygous for the F508del-CFTR mutation

This is a randomized, placebo controlled, double-blinded study. 24 CF subjects will be assigned randomly to two groups, active drug or placebo. Three doses of FDL169 or placebo will be given 3 times a day for 28 days. The aim of this clinical study is to test how well CF subjects tolerate FDL169. In addition, the study will also test how subjects’ bodies absorb and digest FDL169 by measuring study subjects’ blood at specific intervals after taking the tablet orally.

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

28 days

Intervention
The name of the treatment or therapy being researched

FDL169,Placebo

Last edited date

01 November 2017

Sponsor

Flatley Discovery Lab LLC

Sponsor type

Commercial

Who can take part?

Mutation

Two copies of F508del (delta F508)

Age

18+

Top inclusion criteria
  • Weight ≥40 kg
  • Screening laboratory tests with no clinically significant abnormalities that would interfere with the study assessments (as judged by the Investigator)
  • Ability to perform a valid, reproducible spirometry test with demonstration of a forced expiratory volume in 1 sec (FEV1) >40% of predicted normal for age, sex and height.
Top exclusion criteria
  • An acute upper or lower respiratory tract infection, pulmonary exacerbation, or changes in therapy for pulmonary disease within 4 weeks prior to Day 1.
  • Major complications of lung disease (including massive hemoptysis, pneumothorax, or pleural effusion) within 8 weeks prior to screening.
  • Impaired renal function or known portal hypertension.

CF centres running this trial

Recruiting

Royal Brompton and Harefield NHS Foundation Trust

Address

Royal Brompton Hospital Sydney Street London Greater London SW3 6NP

Recruitment starts

August 2017

Recruitment ends

January 2018

Contact

Simmonds, Nicholas

Get in touch

Recruiting

Southampton General Hospital

Address

Tremona Road Southampton Hampshire SO16 6YD

Recruitment starts

September 2017

Recruitment ends

January 2018

Contact

Carroll, Mary

Get in touch