Clinical trial NCT03051711: Study to Evaluate Effects of Investigational Drug on Oxygenation in Healthy Volunteers Under Hypoxic Conditions
Official title: An Open Label Study of GBT440 to Evaluate the Effect on Oxygenation in Healthy Subjects at Rest and Maximal Exercise Under Hypoxic Conditions
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Cardio-pulmonary Function
Lead sponsor: Global Blood Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Mayo Clinic
First posted: 2017-02-14
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: The change in oxygen saturation (%) at rest and exercise, under hypoxic conditions
timeFrame: Day 15
Secondary outcomes:
measure: Maximal oxygen uptake VO2 max (mL/kg/min) under normoxic and hypoxic conditions
timeFrame: Day 15
measure: Cardiac output (L/min) under normoxic and hypoxic conditions
timeFrame: Day 15
measure: Oxy-hemoglobin dissociation curve p50, under hypoxic conditions
timeFrame: Day 15
measure: Perceived dyspnea score (1-10), under normoxic and hypoxic conditions
timeFrame: Day 15
measure: Frequency and severity of treatment-emergent adverse events (TEAEs) as assessed by (NCI CTCAE Version 4.03)
timeFrame: Day 15
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Global Blood Therapeutics
name: Ganesh Balaratnam, MBChB, BAO
role: STUDY_DIRECTOR
References: