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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-10-23

Brief Summary

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

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Detailed Description

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Conditions

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Idiopathic Pulmonary Fibrosis Hypoxemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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GBT440 900 mg Dose

Part A, 900 mg

GBT440: Capsules which contain GBT440 drug substance in Swedish orange

Group Type EXPERIMENTAL

GBT440

Intervention Type DRUG

GBT440: Capsules which contain GBT440 drug substance in Swedish orange

GBT440 1500 mg Dose

Part B , 1500 mg

GBT440: Capsules which contain GBT440 drug substance in Swedish orange

Group Type EXPERIMENTAL

GBT440

Intervention Type DRUG

GBT440: Capsules which contain GBT440 drug substance in Swedish orange

Interventions

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GBT440

GBT440: Capsules which contain GBT440 drug substance in Swedish orange

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No