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

NCT ID: NCT03051711

Last Updated: 2019-10-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2018-02-21

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.

Conditions

Cardio-pulmonary Function

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

GBT440 Dose 1

Dose 1

Group Type: EXPERIMENTAL

GBT440

Intervention Type: DRUG

Capsules which contain GBT440 drug substance in Swedish Orange

GBT440 Dose 2

Dose 2

Group Type: EXPERIMENTAL

GBT440

Intervention Type: DRUG

Capsules which contain GBT440 drug substance in Swedish Orange

Interventions

GBT440

Capsules which contain GBT440 drug substance in Swedish Orange

Intervention Type: DRUG

Other Intervention Names

2-hydroxy-6-((2-(1-isopropyl-1H-pyrazol-5-yl)pyridin-3-yl)methoxy)benzaldehyde

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mayo Clinic

OTHER

Sponsor Role: collaborator

Global Blood Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ganesh Balaratnam, MBChB, BAO

Role: STUDY_DIRECTOR

Global Blood Therapeutics

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

GBT440-0111

Identifier Type: -

Identifier Source: org_study_id