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Completed

NCT Number: NCT02846324

Study to Evaluate the Safety and Tolerability of GBT440 Administered to Subjects With IPF

This study is a randomized, double-blind, placebo-controlled trial in which eligible IPF subjects will be randomized to receive GBT440 or Placebo orally daily.

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Key information

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Documented diagnosis of IPF.
  • Oxygen desaturation with exercise.
  • Completion of the baseline 6MWT
  • Weight ≥ 50 kg
  • Male or female of child bearing potential willing and able to use highly effective methods of contraception from study start to 3 months after the last dose of study drug.

Exclusion criteria

  • FEV1/FVC < 70%.
  • Subjects on supplemental oxygen therapy at rest.
  • History of other interstitial lung diseases.
  • Significant polycythemia.
  • Female who is breast-feeding or pregnant.
  • Known current malignancy or history of malignancy within the last 2 years prior to screening.
  • Use of cytotoxic and/or immunosuppressant medications within 30 days screening.
  • Hospitalization due to an exacerbation of IPF within 30 days of screening
  • Subject plans to begin or has commenced pulmonary rehabilitation within 30 days of screening
  • Corticosteroids (> 10 mg per day of prednisone or an equivalent) within 30 days of screening.
  • Current smoker or history of smoking within 3 months of screening.
  • Currently or, in the opinion of the investigator, soon to be listed for lung transplant.
  • History of unstable or deteriorating cardiac or pulmonary disease (other than IPF) within 6 months of screening.
  • Any condition possibly affecting drug absorption.
  • Participated in another clinical trial of an investigational drug (or medical device) within 30 days or 5-half-lives, whichever is longer, prior to screening, or is currently participating in another trial of an investigational drug (or medical device).
  • Subject who, for any reason, is deemed by the investigator to be inappropriate for this study.

Treatment and study plan

GBT440

Drug

Capsules which contain GBT440 drug substance in Swedish orange

Placebo

Drug

Placebo capsules

Primary outcomes

  1. Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.03

    Time frame: Days 1 to 58

Secondary outcomes

  1. Pharmacokinetic Profile of GBT440 Including Maximum Concentration

    Time frame: Days 1 and 28: pre-dose, and 2 hours post dose (+/- 15 minutes); Day 2: 24 hours (+/- 2 hours) after the Day 1 dose and prior to receiving the Day 2 dose; Days 8 & 15: pre-dose only

  2. Pharmacokinetic Profile of GBT440 Including Minimum Concentration

    Time frame: Days 1 and 28: pre-dose, and 2 hours post dose (+/- 15 minutes); Day 2: 24 hours (+/- 2 hours) after the Day 1 dose and prior to receiving the Day 2 dose; Days 8 & 15: pre-dose only

  3. Pharmacokinetic Profile of GBT440 Including Apparent Terminal Half Life

    Time frame: Days 1 and 28: pre-dose, and 2 hours post dose (+/- 15 minutes); Day 2: 24 hours (+/- 2 hours) after the Day 1 dose and prior to receiving the Day 2 dose; Days 8 & 15: pre-dose only

  4. Evaluate the Effect of GBT440 on Oxygen Saturation Using Pulse Oximetry at Rest

    Time frame: Baseline to Day 28

    Data reported is change from baseline in Oxygen Saturation at rest

  5. Evaluate the Effect of GBT440 on Oxygen Saturation Using Pulse Oximetry After Exercise

    Time frame: Baseline to Day 28

    Change from Baseline to Day 28 after 6MWT

Sponsors and collaborators

Lead sponsor

Global Blood Therapeutics

Industry

Registry information

Official study title

A Phase II Randomized, Placebo-Controlled Study of GBT440 to Evaluate the Safety, Tolerability, Pharmacokinetics and Effect on Hypoxemia in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 27, 2016
Registry last updated
Oct 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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