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Trial record 10 of 22 for:    GBT440

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE January 18, 2017
First Posted Date  ICMJE February 14, 2017
Last Update Posted Date October 4, 2019
Study Start Date  ICMJE December 2016
Actual Primary Completion Date December 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2017)
The change in oxygen saturation (%) at rest and exercise, under hypoxic conditions [ Time Frame: Day 15 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2017)
  • Maximal oxygen uptake VO2 max (mL/kg/min) under normoxic and hypoxic conditions [ Time Frame: Day 15 ]
  • Cardiac output (L/min) under normoxic and hypoxic conditions [ Time Frame: Day 15 ]
  • Oxy-hemoglobin dissociation curve p50, under hypoxic conditions [ Time Frame: Day 15 ]
  • Perceived dyspnea score (1-10), under normoxic and hypoxic conditions [ Time Frame: Day 15 ]
  • Frequency and severity of treatment-emergent adverse events (TEAEs) as assessed by (NCI CTCAE Version 4.03) [ Time Frame: Day 15 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate Effects of Investigational Drug on Oxygenation in Healthy Volunteers Under Hypoxic Conditions
Official Title  ICMJE An Open Label Study of GBT440 to Evaluate the Effect on Oxygenation in Healthy Subjects at Rest and Maximal Exercise Under Hypoxic 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Cardio-pulmonary Function
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: GBT440 Dose 1
    Dose 1
    Intervention: Drug: GBT440
  • Experimental: GBT440 Dose 2
    Dose 2
    Intervention: Drug: GBT440
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 14, 2018)
14
Original Estimated Enrollment  ICMJE
 (submitted: February 9, 2017)
12
Actual Study Completion Date  ICMJE February 21, 2018
Actual Primary Completion Date December 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03051711
Other Study ID Numbers  ICMJE GBT440-0111
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Global Blood Therapeutics
Study Sponsor  ICMJE Global Blood Therapeutics
Collaborators  ICMJE Mayo Clinic
Investigators  ICMJE
Study Director: Ganesh Balaratnam, MBChB, BAO Global Blood Therapeutics
PRS Account Global Blood Therapeutics
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP