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

Global Blood Therapeutics

Status and phase: Terminated; Phase 1

Conditions: Cardio-pulmonary Function

Treatments: Drug: GBT440

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03051711

GBT440-0111

Details and patient eligibility

About

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

Full description

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

Enrollment: 14 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

GBT440 Dose 1

Experimental group

Description:

Dose 1

Treatment:

Drug: GBT440

GBT440 Dose 2

Experimental group

Description:

Dose 2

Treatment:

Drug: GBT440