Cystic FibrosisPhase 1NCT01793649
A Phase 1 Study to Characterize the Effect of GS-5737 Enhancement of Mucociliary Clearance (MCC) in Healthy Subjects
A Phase 1 study testing GS-5737 in people with Cystic Fibrosis and Chronic Obstructive Pulmonary Disease, run by Gilead Sciences at 1 site in United States.
Trial summary
This is a randomized, double-blind, cross-over, vehicle-controlled study to determine whether GS-5737 in 2.8% saline accelerates mucociliary clearance (MCC) in healthy subjects, compared to vehicle of 2.8% saline alone. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis, Chronic Obstructive Pulmonary Disease
- What is being tested?
- GS-5737
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Jun 2013
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) from ≥ 19 to ≤ 30 kg/m2
- Normal ECG, with no history or evidence of myocardial infarction, QT prolongation, or ventricular arrhythmias
- Normal (or abnormal but not clinically significant) blood pressure (BP) and heart rate(HR)
- History of lifetime smoking < 5 pack-years (ie, 1 pack per day x 1 year = 1 pack-year)and non-smokers of at least 60 days duration prior to Screening
- Negative screening tests for drugs of abuse (including alcohol)
- Hepatitis B (HBV) surface antigen negative
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- Hepatitis C (HCV) antibody negative
- HIV-1, 2 antibody negative
- Male subjects who are sexually active must be willing to use highly effective contraception from the Baseline Visit through completion of the study and continuing for at least 90 days from the date of the last dose of study drug
- Male subjects must refrain from sperm donation from the Baseline Visit through completion of the study and continuing for at least 90 days from the date of the last dose of study drug
- Females of childbearing potential must have a negative serum pregnancy test
- Females of childbearing potential must agree to utilize protocol recommended highly effective contraception methods from Screening throughout the duration of study treatment and for 30 days following the last dose of study drug
Who cannot join
- Female subjects who are pregnant or lactating
- History of anaphylactic reaction to any drug
- Have previously participated in an investigational trial involving administration of any investigational compound within 30 days prior to the study drug dosing
- Presence or history of extrinsic allergy requiring treatment; hay fever is allowed unless it is active or has required treatment within the previous 2 months
- Have donated blood within 56 days of study dosing
- Presence or history of any pulmonary diseases (ie, asthma, emphysema, chronic bronchitis, chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF), bronchiectasis, interstitial lung disease)
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- Major surgery within 6 months of Screening
- Experienced symptoms of recent acute upper or lower respiratory tract infection requiring treatment within the 2 weeks prior to Screening
- Have had any radiation in the past year that would cause the subject exceed recommended limits by participating in this study protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
Investigational Site
Chapel Hill, North Carolina, 27599
About this study
Official title: A Phase 1, Randomized, Double-Blind, Cross-Over, Vehicle-Controlled, Single-Dose Study To Characterize The Effect of GS-5737 Enhancement of Mucociliary Clearance (MCC) In Healthy Subjects
This is a randomized, double-blind, cross-over, vehicle-controlled study to determine whether GS-5737 in 2.8% saline accelerates mucociliary clearance (MCC) in healthy subjects, compared to vehicle of 2.8% saline alone.
- Being tested
- GS-5737
- Keywords
- Respiratory health, Cystic Fibrosis, Chronic Obstructive Pulmonary Disease
- Medical subject headings
- Cystic Fibrosis, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GS-5737Drug
A single dose of GS-5737 in 2.8% saline
| Study group | Role | What they receive |
|---|---|---|
| Cross-Over Sequence 1 | Experimental | 85 μg GS-5737 in 2.8% saline or 2.8% saline alone (blinded) Receives: Drug: GS-5737 |
| Cross-Over Sequence 2 | Experimental | 2.8% saline alone or 85 μg GS-5737 in 2.8% saline (blinded) Receives: Drug: GS-5737 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve of MCC from Whole Lung Compartment
The primary endpoint of this study will be the calculated area under the curve of MCC from the whole lung compartment, assessed through 60 minutes post isotope dosing (AUC-60min), which will provide a description of the MCC curve.
Measured: 4 weeks
Secondary outcomes (1)
Area under the curve of MCC from Central and Peripheral Lung
This outcome measure will be the calculated area under the cuve of MCC from the central and peripheral lung assessed through 60 minutes post isotope dosing (AUC60min).
Measured: 4 weeks or duration of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startOct 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Bresnik, M.D., Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01793649
- Sponsor's protocol ID
- GS-US-234-0103
- Status last verified
- Mar 2014
- First submitted
- 14 Feb 2013
- Last updated
- 20 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Cross-Over, Vehicle-Controlled, Single-Dose Study To Characterize The Effect of GS-5737 Enhancement of Mucociliary Clearance (MCC) In Healthy Subjects
- ClinicalTrials.gov ID
- NCT01793649
- Acronym / sponsor ID
- GS-US-234-0103
- Keywords
- Respiratory health, Cystic Fibrosis, Chronic Obstructive Pulmonary Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 15 Feb 2013 (estimated)
- 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.
This is a randomized, double-blind, cross-over, vehicle-controlled study to determine whether GS-5737 in 2.8% saline accelerates mucociliary clearance (MCC) in healthy subjects, compared to vehicle of 2.8% saline alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cross-Over Sequence 1 | Experimental | Drug: GS-573785 μg GS-5737 in 2.8% saline or 2.8% saline alone (blinded) |
| Cross-Over Sequence 2 | Experimental | Drug: GS-57372.8% saline alone or 85 μg GS-5737 in 2.8% saline (blinded) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Body mass index (BMI) from ≥ 19 to ≤ 30 kg/m2
- Normal ECG, with no history or evidence of myocardial infarction, QT prolongation, or ventricular arrhythmias
- Normal (or abnormal but not clinically significant) blood pressure (BP) and heart rate(HR)
- History of lifetime smoking < 5 pack-years (ie, 1 pack per day x 1 year = 1 pack-year)and non-smokers of at least 60 days duration prior to Screening
- Negative screening tests for drugs of abuse (including alcohol)
Key exclusion criteria (9 listed)
- Female subjects who are pregnant or lactating
- History of anaphylactic reaction to any drug
- Have previously participated in an investigational trial involving administration of any investigational compound within 30 days prior to the study drug dosing
- Presence or history of extrinsic allergy requiring treatment; hay fever is allowed unless it is active or has required treatment within the previous 2 months
- Have donated blood within 56 days of study dosing
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 |
|---|---|---|
| GS-5737A single dose of GS-5737 in 2.8% saline | Drug | Cross-Over Sequence 1, Cross-Over Sequence 2 |
Primary outcome
Area under the curve of MCC from Whole Lung Compartment
Time frame: 4 weeks
The primary endpoint of this study will be the calculated area under the curve of MCC from the whole lung compartment, assessed through 60 minutes post isotope dosing (AUC-60min), which will provide a description of the MCC curve.
1 secondary outcome
Area under the curve of MCC from Central and Peripheral Lung
Time frame: 4 weeks or duration of study
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2014.
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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.
Mark Bresnik, M.D. study director
Gilead Sciences
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 GS-5737 in people with Cystic Fibrosis and Chronic Obstructive Pulmonary Disease, run by Gilead Sciences 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 12 inclusion and 9 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 20 Mar 2014. 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. 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?
Area under the curve of MCC from Whole Lung Compartment (time frame: 4 weeks). 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 20 Mar 2014.