Study to Evaluate Effects of Investigational Drug on Oxygenation in Healthy Volunteers Under Hypoxic Conditions
Stopped early · Phase 1
Conditions studied: Cardio-pulmonary Function
In brief
To evaluate the effect of GBT440 on oxygen saturation at rest and exercise, under hypoxic conditions, at Day 15 compared to Baseline.
Key facts
- Study ID
- NCT03051711
- Run by
- Global Blood Therapeutics
- People needed
- 14
- Starts
- 2016-12-01
- Expected to finish
- 2018-02-21
- Last updated by the study team
- 2019-10-04
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Males or females aged 18 - 50 years inclusive
- Able and willing to provide signed informed consent to participate in this study
- VO2 max ≥ 40 mL/kg/min for males, and ≥ 35 mL/kg/min for females
- Weight ≥ 40 kg
- Male or female of child bearing potential willing and able to use highly effective methods of contraception during the study to 30 days after the last dose of study drug.
You may not qualify if…
- Subjects whose exercise regimen at Screening is, in the Investigator's opinion, expected to change significantly during the study
- Family or personal history of congenital long QT syndrome
- 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)
- Clinically significant medical disease that is likely, in the Investigator's opinion, to significantly impact the study's efficacy and safety assessments (e.g., history significant cardio-pulmonary disease or arrhythmias) within 6 months of Screening.
- AST, ALT or total bilirubin >2 × ULN
- Serum creatinine >1.5 mg/dL
- Clinical evidence of active infection, within 21 days of Screening, which may include but is not limited to bronchitis, pneumonia, urinary tract infection, or cellulitis.
- Female who is breast-feeding or pregnant
- Current smoker or history of smoking within 3 months from Screening
- Any condition possibly affecting drug absorption, including but not limited to previous surgery on the stomach or small intestine
- Known hypersensitivity to any component of the study drug
Where it is running
- Mayo Clinic — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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