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

Phase 2TerminatedNCT02989168

Global Blood Therapeutics14 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Idiopathic Pulmonary Fibrosis Hypoxemia

Interventions

GBT440DRUG

GBT440: Capsules which contain GBT440 drug substance in Swedish orange

Eligibility

Sex: ALLMin age: 45 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (9)

Unnamed facility

Birmingham, Alabama, United States

Unnamed facility

Denver, Colorado, United States

Unnamed facility

New Orleans, Louisiana, United States

Unnamed facility

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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

Time frame: Days 1 to 90

Secondary Outcomes

Change in Supplemental Oxygen Requirement at End of Treatment Period Compared to Baseline

Time frame: Days 1 to 90

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

Evaluate the Effect of GBT440 on Performance of the 6MWT

Time frame: Days 1 to 90

Evaluate the Effect of GBT440 on IPF Related Symptoms Using Patient Related Outcomes

Time frame: Days 1 to 90

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).

Time frame: Days 1 to 90

Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0

Time frame: Days 1 to 90

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.

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)

Data from ClinicalTrials.gov

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