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

Idiopathic Pulmonary Fibrosis Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02846324
• Other study ID #: GBT440-006
• Status: Completed
• Phase: Phase 2
• Start date: June 2016
• Est. completion date: November 2017

Study information

• Verified date: September 2020
• Source: Global Blood Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: November 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Hypoxemia
• Hypoxia
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• GBT440
Capsules which contain GBT440 drug substance in Swedish orange
• Placebo
Placebo capsules

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Global Blood Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.03		Days 1 to 58
Secondary	Pharmacokinetic Profile of GBT440 Including Maximum Concentration		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
Secondary	Pharmacokinetic Profile of GBT440 Including Minimum Concentration		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
Secondary	Pharmacokinetic Profile of GBT440 Including Apparent Terminal Half Life		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
Secondary	Evaluate the Effect of GBT440 on Oxygen Saturation Using Pulse Oximetry at Rest	Data reported is change from baseline in Oxygen Saturation at rest	Baseline to Day 28
Secondary	Evaluate the Effect of GBT440 on Oxygen Saturation Using Pulse Oximetry After Exercise	Change from Baseline to Day 28 after 6MWT	Baseline to Day 28