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

Global Blood Therapeutics

Status and phase: Terminated; Phase 2

Conditions: Idiopathic Pulmonary Fibrosis; Hypoxemia

Treatments: Drug: GBT440

Study type: Interventional

Funder types: Industry

Identifiers

NCT02989168

GBT440-026

Details and patient eligibility

About

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

Enrollment: 14 patients

Sex: All

Ages: 45 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

GBT440 900 mg Dose

Experimental group

Description:

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

Treatment:

Drug: GBT440

GBT440 1500 mg Dose

Experimental group

Description:

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

Treatment:

Drug: GBT440