Phase 2
Completed N=39
Study to Evaluate the Safety and Tolerability of GBT440 Administered to Subjects With IPF
Source: ClinicalTrials.gov NCT02846324 ↗Enrolled (actual)
39
Serious AEs
12.8%
Results posted
Sep 2020
Primary outcomePrimary: Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.03 — 8; 7; 4; 11 Participants
Summary
This study is a randomized, double-blind, placebo-controlled trial in which eligible IPF subjects will be randomized to receive GBT440 or Placebo orally daily.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.03 |
8; 7; 4; 11 | — |
| SECONDARY Pharmacokinetic Profile of GBT440 Including Maximum Concentration |
— | — |
| SECONDARY Pharmacokinetic Profile of GBT440 Including Minimum Concentration |
— | — |
| SECONDARY Pharmacokinetic Profile of GBT440 Including Apparent Terminal Half Life |
— | — |
| SECONDARY Evaluate the Effect of GBT440 on Oxygen Saturation Using Pulse Oximetry at Rest |
-1.1; 0.3; 0.4; 0.9 | — |
| SECONDARY Evaluate the Effect of GBT440 on Oxygen Saturation Using Pulse Oximetry After Exercise |
-1.7; 2.9; 3.5; 3.5 | — |
Eligibility Criteria
Inclusion Criteria
- Documented diagnosis of IPF.
- Oxygen desaturation with exercise.
- Completion of the baseline 6MWT
- Weight ≥ 50 kg
- Male or female of child bearing potential willing and able to use highly effective methods of contraception from study start to 3 months after the last dose of study drug.
Exclusion Criteria
- FEV1/FVC 10 mg per day of prednisone or an equivalent) within 30 days of screening.
- Current smoker or history of smoking within 3 months of screening.
- Currently or, in the opinion of the investigator, soon to be listed for lung transplant.
- History of unstable or deteriorating cardiac or pulmonary disease (other than IPF) within 6 months of screening.
- Any condition possibly affecting drug absorption.
- 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).
- Subject who, for any reason, is deemed by the investigator to be inappropriate for this study.
Data sourced from ClinicalTrials.gov (NCT02846324). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.