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

Cardio-pulmonary Function Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03051711
• Other study ID #: GBT440-0111
• Status: Terminated
• Phase: Phase 1
• Start date: December 2016
• Est. completion date: February 21, 2018

Study information

• Verified date: October 2019
• Source: Global Blood Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

This study in healthy subjects will evaluate GBT440 and its effects on cardio-pulmonary function under both normoxic and hypoxic conditions.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: February 21, 2018
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardio-pulmonary Function
• Hypoxia

Intervention

Drug:
• GBT440
Capsules which contain GBT440 drug substance in Swedish Orange

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Global Blood Therapeutics	Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in oxygen saturation (%) at rest and exercise, under hypoxic conditions		Day 15
Secondary	Maximal oxygen uptake VO2 max (mL/kg/min) under normoxic and hypoxic conditions		Day 15
Secondary	Cardiac output (L/min) under normoxic and hypoxic conditions		Day 15
Secondary	Oxy-hemoglobin dissociation curve p50, under hypoxic conditions		Day 15
Secondary	Perceived dyspnea score (1-10), under normoxic and hypoxic conditions		Day 15
Secondary	Frequency and severity of treatment-emergent adverse events (TEAEs) as assessed by (NCI CTCAE Version 4.03)		Day 15