A Study to Evaluate the Effect of GBT440 on Oxygenation in Healthy Subjects, both at Rest and at Maximal Exercise

Overview

About this study

The purpose of this study is to evaluate the effects of GBT440 on the body and oxygen saturation levels , assessed at rest and at maximum exercise under conditions of low oxygen in the atmosphere.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Males or females
  • Age 18 – 50 years inclusive
  • Able and willing to provide signed informed consent to participate in this study
  • VO2 max > 40 mL/kg/min for males, and > 35 mL/kg/min for females
  • Able, in the Investigator’s opinion, to complete the maximal exercise test unassisted, under normoxic and hypoxic conditions, at baseline and day 15
  • Weight ≥ 40 kg
  • Able, in the Investigator’s opinion, to comply with the study procedures,including attending the assessment visits and adhering to study requirements and restrictions
  • 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

  • Exercise regimen at screening is, in the Investigator’s opinion, expected to change significantly during the study
  • Hemoglobin value of < 11 or > 17 mg/dL
  • ECG with a QTcF ≥ 430 ms (males) or QTcF ≥ 450 ms (females)
  • Family or personal history of congenital long QT syndrome
  • 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
  • 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
  • AST, ALT or total bilirubin >2 × ULN
  • Serum creatinine >1.5 mg/dL
  • 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
  • Active viral hepatitis or tuberculosis within the last 6 months
  • Female who is breast-feeding or pregnant
  • Known current malignancy , current evaluation for a potential malignancy, or history of malignancy within the past 2 years prior to screening,
    • Except for appropriately treated non-melanoma skincarcinoma
  • Current smoker or history of smoking within 3 months from screening
  • Any condition possibly affecting drug absorption, including but not limited to previous surgery on the stomach or small intestine
  • Known hypersensitivity to any component of the study drug
  • Use of St John’s wort within 7 days of study enrollment or
  • Use of any over the counter product or drug (e.g. coumadin) that is likely, in the Investigator’s opinion, to significantly impact the study’s safety and efficacy assessments, within 14 days of study enrollment

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Bruce Johnson, Ph.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20301845

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