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

Primary Purpose

Idiopathic Pulmonary Fibrosis, Hypoxemia

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GBT440
Sponsored by
Global Blood Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Idiopathic Pulmonary Fibrosis focused on measuring Idiopathic pulmonary fibrosis, hypoxemia, oxygen

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

GBT440 900 mg Dose

GBT440 1500 mg Dose

Arm Description

Part A, 900 mg GBT440: Capsules which contain GBT440 drug substance in Swedish orange

Part B , 1500 mg GBT440: Capsules which contain GBT440 drug substance in Swedish orange

Outcomes

Primary Outcome Measures

Change in Oxygen Saturation at End of Treatment Period Compared to Baseline

Secondary Outcome Measures

Change in Supplemental Oxygen Requirement at End of Treatment Period Compared to Baseline
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
Evaluate the Effect of GBT440 on Performance of the 6MWT
Evaluate the Effect of GBT440 on IPF Related Symptoms Using Patient Related Outcomes
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).
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
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.

Full Information

First Posted
November 28, 2016
Last Updated
July 31, 2020
Sponsor
Global Blood Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT02989168
Brief Title
Study to Evaluate the Effect of GBT440 Administered to Subjects With IPF on Supplemental Oxygen at Rest
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated due to lack of clinically meaningful benefit
Study Start Date
November 2016 (undefined)
Primary Completion Date
October 23, 2017 (Actual)
Study Completion Date
October 23, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Global Blood Therapeutics

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis, Hypoxemia
Keywords
Idiopathic pulmonary fibrosis, hypoxemia, oxygen

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GBT440 900 mg Dose
Arm Type
Experimental
Arm Description
Part A, 900 mg GBT440: Capsules which contain GBT440 drug substance in Swedish orange
Arm Title
GBT440 1500 mg Dose
Arm Type
Experimental
Arm Description
Part B , 1500 mg GBT440: Capsules which contain GBT440 drug substance in Swedish orange
Intervention Type
Drug
Intervention Name(s)
GBT440
Intervention Description
GBT440: Capsules which contain GBT440 drug substance in Swedish orange
Primary Outcome Measure Information:
Title
Change in Oxygen Saturation at End of Treatment Period Compared to Baseline
Time Frame
Days 1 to 90
Secondary Outcome Measure Information:
Title
Change in Supplemental Oxygen Requirement at End of Treatment Period Compared to Baseline
Time Frame
Days 1 to 90
Title
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
Time Frame
Days 1 to 90
Title
Evaluate the Effect of GBT440 on Performance of the 6MWT
Time Frame
Days 1 to 90
Title
Evaluate the Effect of GBT440 on IPF Related Symptoms Using Patient Related Outcomes
Time Frame
Days 1 to 90
Title
Evaluate Pulmonary Function Using Pulmonary Function Tests (FVC and DLco)
Description
Spirometry measurements will include forced vital capacity (FVC) and diffusing capacity of the lung for carbon monoxide (DLco).
Time Frame
Days 1 to 90
Title
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Time Frame
Days 1 to 90
Title
Pharmacokinetic Parameters of GBT440 in Plasma and Whole Blood (Minimum Concentration (Cmin))
Description
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.
Time Frame
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70122
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom
City
Manchester
ZIP/Postal Code
M23 9QZ
Country
United Kingdom
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom

12. IPD Sharing Statement

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

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