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Safety, Tolerability, and Pharmacokinetics of PTI-808, PTI-801, and PTI-428 Combination Therapy in Subjects 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

Full title

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study Designed to Evaluate the Safety, Tolerability, and Pharmacokinetics of PTI-808-02, and PTI-428 Combination Therapy in Subjects With Cystic Fibrosis

The study is a randomized, double-blind, placebo-controlled, study that will be conducted at multiple centers in subjects with Cystic Fibrosis (CF) who are homozygous for the F508del mutation.

Trial Reference Number

108654

Trial type

Medication

Intervention
the name of the treatment or therapy being researched

PTI-808,Placebo,PTI-801,PTI-428

Last edited date

28 January 2019

CF sponsor

Proteostasis Therapeutics, Inc.

CF sponsor type

Commercial

Who can take part?

Age

18+

Top inclusion criteria
  • Confirmed diagnosis of CF with the F508del/F508del genotype on record, along with clinical findings consistent with CF such as chronic sinopulmonary disease or gastrointestinal/nutritional abnormalities.
  • Forced expiratory volume in 1 second (FEV1) 40-90% predicted, inclusive.
  • Non-smoker and non-tobacco user for a minimum of 30 days prior to screening
Top exclusion criteria
  • Currently taking or has taken a CFTR modulator within 30 days prior to initial dose of study drugs.
  • Participation in another clinical trial or treatment with an investigational agent within 28 days or 5 half-lives, whichever is longer, prior to Study Day 1.
  • History of organ transplantation.

CF centres running this trial

Closed

Celerion Research Institute

Address

22-24 Lisburn Rd Belfast BT9 6AD

Recruitment ends

September 2018

Contact

,

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Closed

Medicines Evaluation Unit

Address

The Langley Building Southmoor Road Wythenshawe Manchester M23 9QZ

Contact

Horsley, Alexander

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Closed

Queen Elizabeth University Hospital

Address

1345 Govan Road G51 4TF

Contact

,

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Closed

Western General Hospital

Address

Crewe Road South Edinburgh EH4 2XU

Contact

,

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