Cardio-pulmonary FunctionPhase 1NCT03051711
Study to Evaluate Effects of Investigational Drug on Oxygenation in Healthy Volunteers Under Hypoxic Conditions
A Phase 1 study testing GBT440 in people with Cardio-pulmonary Function, run by Global Blood Therapeutics at 1 site in United States.
Trial summary
To evaluate the effect of GBT440 on oxygen saturation at rest and exercise, under hypoxic conditions, at Day 15 compared to Baseline. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardio-pulmonary Function
- What is being tested?
- GBT440
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to 21 Feb 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males or females aged 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
- Weight ≥ 40 kg
- 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.
Who cannot join
- Subjects whose exercise regimen at Screening is, in the Investigator's opinion, expected to change significantly during the study
- 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
Show all 11Show fewer
- 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.
- Female who is breast-feeding or pregnant
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
To evaluate the effect of GBT440 on oxygen saturation at rest and exercise, under hypoxic conditions, at Day 15 compared to Baseline.
Read the 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
- Being tested
- GBT440
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GBT440Drug
Also called 2-hydroxy-6-((2-(1-isopropyl-1H-pyrazol-5-yl)pyridin-3-yl)methoxy)benzaldehyde
Capsules which contain GBT440 drug substance in Swedish Orange
| Study group | Role | What they receive |
|---|---|---|
| GBT440 Dose 1 | Experimental | Dose 1 Receives: Drug: GBT440 |
| GBT440 Dose 2 | Experimental | Dose 2 Receives: Drug: GBT440 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in oxygen saturation (%) at rest and exercise, under hypoxic conditions
Measured: Day 15
Secondary outcomes (5)
Maximal oxygen uptake VO2 max (mL/kg/min) under normoxic and hypoxic conditions
Measured: Day 15
Cardiac output (L/min) under normoxic and hypoxic conditions
Measured: Day 15
Oxy-hemoglobin dissociation curve p50, under hypoxic conditions
Measured: Day 15
Perceived dyspnea score (1-10), under normoxic and hypoxic conditions
Measured: Day 15
Frequency and severity of treatment-emergent adverse events (TEAEs) as assessed by (NCI CTCAE Version 4.03)
Measured: Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study startDec 2016
- Primary completion1 Dec 2017
- Study completion21 Feb 2018
Why it stopped: Sponsor discontinued IPF Program on 23-Oct. 2017 based on POC studies
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardio-pulmonary FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Global Blood Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic
- Responsible party
- Sponsor
- Investigators
- Ganesh Balaratnam, MBChB, BAO, Study director, Global Blood Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03051711
- Sponsor's protocol ID
- GBT440-0111
- Status last verified
- Oct 2019
- First submitted
- 18 Jan 2017
- Last updated
- 4 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03051711
- Acronym / sponsor ID
- GBT440-0111
- Conditions
- Cardio-pulmonary Function
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor discontinued IPF Program on 23-Oct. 2017 based on POC studies
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Global Blood TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic
- Study start
- Dec 2016
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 21 Feb 2018 (actual)
- First posted
- 14 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GBT440 Dose 1 | Experimental | Drug: GBT440Dose 1 |
| GBT440 Dose 2 | Experimental | Drug: GBT440Dose 2 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Males or females aged 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
- Weight ≥ 40 kg
- 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.
Key exclusion criteria (11 listed)
- Subjects whose exercise regimen at Screening is, in the Investigator's opinion, expected to change significantly during the study
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GBT440Also: 2-hydroxy-6-((2-(1-isopropyl-1H-pyrazol-5-yl)pyridin-3-yl)methoxy)benzaldehydeCapsules which contain GBT440 drug substance in Swedish Orange | Drug | GBT440 Dose 1, GBT440 Dose 2 |
Primary outcome
The change in oxygen saturation (%) at rest and exercise, under hypoxic conditions
Time frame: Day 15
5 secondary outcomes
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
Results and safety
The study was stopped early (reason given: Sponsor discontinued IPF Program on 23-Oct. 2017 based on POC studies). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ganesh Balaratnam, MBChB, BAO study director
Global Blood Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GBT440 in people with Cardio-pulmonary Function, run by Global Blood Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor discontinued IPF Program on 23-Oct. 2017 based on POC studies). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in oxygen saturation (%) at rest and exercise, under hypoxic conditions (time frame: Day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2019.