Cardio-pulmonary Function
Conditions
Brief summary
To evaluate the effect of GBT440 on oxygen saturation at rest and exercise, under hypoxic conditions, at Day 15 compared to Baseline.
Detailed description
This study in healthy subjects will evaluate GBT440 and its effects on cardio-pulmonary function under both normoxic and hypoxic conditions.
Interventions
DRUGGBT440
Capsules which contain GBT440 drug substance in Swedish Orange
Sponsors
Mayo Clinic
Global Blood Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Males or females aged 18 - 50 years inclusive 2. Able and willing to provide signed informed consent to participate in this study 3. VO2 max ≥ 40 mL/kg/min for males, and ≥ 35 mL/kg/min for females 4. Weight ≥ 40 kg 5. 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.
Exclusion criteria
1. Subjects whose exercise regimen at Screening is, in the Investigator's opinion, expected to change significantly during the study 2. Family or personal history of congenital long QT syndrome 3. 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) 4. 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. 5. AST, ALT or total bilirubin \>2 × ULN 6. Serum creatinine \>1.5 mg/dL 7. 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. 8. Female who is breast-feeding or pregnant 9. Current smoker or history of smoking within 3 months from Screening 10. Any condition possibly affecting drug absorption, including but not limited to previous surgery on the stomach or small intestine 11. Known hypersensitivity to any component of the study drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in oxygen saturation (%) at rest and exercise, under hypoxic conditions | Day 15 |
Secondary
| Measure | Time frame |
|---|---|
| Maximal oxygen uptake VO2 max (mL/kg/min) under normoxic and hypoxic conditions | Day 15 |
| Cardiac output (L/min) under normoxic and hypoxic conditions | Day 15 |
| Oxy-hemoglobin dissociation curve p50, under hypoxic conditions | Day 15 |
| Perceived dyspnea score (1-10), under normoxic and hypoxic conditions | Day 15 |
| Frequency and severity of treatment-emergent adverse events (TEAEs) as assessed by (NCI CTCAE Version 4.03) | Day 15 |
Countries
United States
Outcome results
None listed