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Study to Evaluate Effects of Investigational Drug on Oxygenation in Healthy Volunteers Under Hypoxic Conditions

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ClinicalTrials.gov Identifier: NCT03051711
Recruitment Status : Terminated (Sponsor discontinued IPF Program on 23-Oct. 2017 based on POC studies)
First Posted : February 14, 2017
Last Update Posted : October 4, 2019
Sponsor:
Collaborator:
Mayo Clinic
Information provided by (Responsible Party):
Global Blood Therapeutics

Study Description
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Brief Summary:
To evaluate the effect of GBT440 on oxygen saturation at rest and exercise, under hypoxic conditions, at Day 15 compared to Baseline.

Condition or disease Intervention/treatment Phase
Cardio-pulmonary Function Drug: GBT440 Phase 1

Expanded Access : An investigational treatment associated with this study has been approved for sale to the public.   More info ...

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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 Start Date : December 2016
Actual Primary Completion Date : December 1, 2017
Actual Study Completion Date : February 21, 2018
Arms and Interventions
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Arm Intervention/treatment
Experimental: GBT440 Dose 1
Dose 1
 Drug: GBT440
Capsules which contain GBT440 drug substance in Swedish Orange
Other Name: 2-hydroxy-6-((2-(1-isopropyl-1H-pyrazol-5-yl)pyridin-3-yl)methoxy)benzaldehyde
Experimental: GBT440 Dose 2
Dose 2
 Drug: GBT440
Capsules which contain GBT440 drug substance in Swedish Orange
Other Name: 2-hydroxy-6-((2-(1-isopropyl-1H-pyrazol-5-yl)pyridin-3-yl)methoxy)benzaldehyde


Outcome Measures
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Primary Outcome Measures :
  1. The change in oxygen saturation (%) at rest and exercise, under hypoxic conditions [ Time Frame: Day 15 ]

Secondary Outcome Measures :
  1. Maximal oxygen uptake VO2 max (mL/kg/min) under normoxic and hypoxic conditions [ Time Frame: Day 15 ]
  2. Cardiac output (L/min) under normoxic and hypoxic conditions [ Time Frame: Day 15 ]
  3. Oxy-hemoglobin dissociation curve p50, under hypoxic conditions [ Time Frame: Day 15 ]
  4. Perceived dyspnea score (1-10), under normoxic and hypoxic conditions [ Time Frame: Day 15 ]
  5. Frequency and severity of treatment-emergent adverse events (TEAEs) as assessed by (NCI CTCAE Version 4.03) [ Time Frame: Day 15 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03051711


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Global Blood Therapeutics
Mayo Clinic
Investigators
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Study Director: Ganesh Balaratnam, MBChB, BAO Global Blood Therapeutics
More Information
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Responsible Party: Global Blood Therapeutics
ClinicalTrials.gov Identifier: NCT03051711    
Other Study ID Numbers: GBT440-0111
First Posted: February 14, 2017    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hypoxia
Signs and Symptoms, Respiratory
Pyrazole
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action