Study to Evaluate the Effect of GBT440 Administered to Subjects With IPF on Supplemental Oxygen at Rest

Idiopathic Pulmonary Fibrosis Clinical Trial

— Zephyr  

Official title:

A Phase II Open Label Study to Evaluate the Effect of GBT440 on Hypoxemia in Subjects With Idiopathic Pulmonary Fibrosis (IPF) Who Are Using Supplemental Oxygen at Rest (ZEPHYR)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02989168
• Other study ID #: GBT440-026
• Status: Terminated
• Phase: Phase 2
• Start date: November 2016
• Est. completion date: October 23, 2017

Study information

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

Clinical Trial Summary

This is an open label study in which eligible IPF subjects who are using supplemental oxygen at rest will receive GBT440 orally daily.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: October 23, 2017
• Est. primary completion date: October 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 85 Years

Eligibility

Inclusion Criteria:

• Documented diagnosis of IPF.

• Receiving supplemental oxygen for use at rest.

• Weight = 40 kg.

• Male or female of child bearing potential willing and able to use highly effective methods of contraception from study start to 30 days after the last dose of study drug.

Exclusion Criteria:

• FEV1/FVC < 70%

• History of other interstitial lung diseases.

• Subject plans to begin or has commenced pulmonary rehabilitation within 30 days of screening.

• Corticosteroid (> 10 mg per day of prednisone or an equivalent) administered for 7 days or longer, within 30 days of screening.

• 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).

• Female who is breast-feeding or pregnant

• Current smoker or history of smoking within 3 months from screening

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Global Blood Therapeutics

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Oxygen Saturation at End of Treatment Period Compared to Baseline		Days 1 to 90
Secondary	Change in Supplemental Oxygen Requirement at End of Treatment Period Compared to Baseline		Days 1 to 90
Secondary	Evaluate the Effect of GBT440 on Resting and Post-exercise Alveolar-arterial O2 Tension Difference [P(A-a) O2] at End of Treatment Period Compared to Baseline		Days 1 to 90
Secondary	Evaluate the Effect of GBT440 on Performance of the 6MWT		Days 1 to 90
Secondary	Evaluate the Effect of GBT440 on IPF Related Symptoms Using Patient Related Outcomes		Days 1 to 90
Secondary	Evaluate Pulmonary Function Using Pulmonary Function Tests (FVC and DLco)	Spirometry measurements will include forced vital capacity (FVC) and diffusing capacity of the lung for carbon monoxide (DLco).	Days 1 to 90
Secondary	Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0		Days 1 to 90
Secondary	Pharmacokinetic Parameters of GBT440 in Plasma and Whole Blood (Minimum Concentration (Cmin))	PK parameters of GBT440 administered daily orally for 90 days in plasma and whole blood, including but not limited to, minimum concentration (Cmin), at steady state.	Day 1 (15 mins post-dose and 2-4h post-dose), Day 15 (pre-dose), Day 30 (pre-dose), Day 60 (pre-dose and 2-4h post-dose), Day 90 (pre-dose), Day 105 (during study visit), and Day 120 (during study visit)