NCT03051711TerminatedPhase 1
An Open Label Study of GBT440 to Evaluate the Effect on Oxygenation in Healthy Subjects at Rest and Maximal Exercise Under Hypoxic Conditions
Global Blood Therapeutics1 site in 1 country14 target enrollmentStarted: December 2016Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- The change in oxygen saturation (%) at rest and exercise, under hypoxic conditions
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
GBT440 Dose 1
Experimental
Dose 1
Intervention: GBT440 (Drug)
GBT440 Dose 2
Experimental
Dose 2
Intervention: GBT440 (Drug)
Outcomes
Primary Outcomes
The change in oxygen saturation (%) at rest and exercise, under hypoxic conditions
Time Frame: Day 15
Secondary Outcomes
- Maximal oxygen uptake VO2 max (mL/kg/min) under normoxic and hypoxic conditions(Day 15)
- Perceived dyspnea score (1-10), 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)
- Frequency and severity of treatment-emergent adverse events (TEAEs) as assessed by (NCI CTCAE Version 4.03)(Day 15)
Investigators
Study Sites (1)
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