Cystic FibrosisPhase 1NCT00951522
A Trial to Assess the Safety, Tolerability, and Pharmacokinetics of GS-9411 in Healthy Male Volunteers
A Phase 1 study testing GS-9411 in people with Cystic Fibrosis and Mucociliary Clearance, run by Gilead Sciences at 1 site in Australia.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of escalating doses of GS-9411 in healthy male volunteers. GS-9411 is a sodium channel inhibitor, that may restore airway hydration and mucociliary clearance in the lung. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis, Mucociliary Clearance, Airway Hydration
- What is being tested?
- GS-9411
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteAustralia
- Study dates
- Sep 2009to Sep 2009
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males 18 to 45 years of age
- No clinically important abnormal physical findings at the screening examination
- No clinically relevant abnormalities in the results of laboratory screening evaluation
- Normal (or abnormal but not clinically significant) ECG
- Normal (or abnormal but not clinically significant) blood pressure (BP) and heart rate(HR).
- Body weight between 70 and 125 kg and body mass index (BMI) between 18 and 28 kg/m2.
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- Able to communicate well with the investigator and to comply with the requirements of the entire study.
- Provision of written informed consent to participate as shown by a signature on the volunteer consent form.
- Non-smokers of at least 6 months duration (< 10 pack/year history) prior to study entry.
- Negative for drugs of abuse (including alcohol) at Screening and Day -5.
- Must be willing to abstain from alcohol and strenuous exercise during the 48-hour period prior to admission and during the study.
- Forced expiratory volume in 1 second (FEV1) ≥ 80% of predicted normal for age, gender, and height at Screening and Pre-dose.
- Normal intraocular pressure between 10 and 21 mm Hg.
- Male subjects who are sexually active must be willing to use effective barrier contraception (e.g., condoms) during heterosexual intercourse from Baseline/Day 0 through completion of the study and continuing for at least 90 days from date of last dose of study drug.
- Male subjects must refrain from sperm donation from Day 1 through completion of the study and continuing for at least 90 days from the date of last dose of study drug.
Who cannot join
- Any prior exposure to GS-9411.
- Administration of any investigational drug in the period 0 to 12 weeks before entry to the study.
- A need for any medication during the period 0 to 5 days before entry to the study, except those deemed by the principal investigator/clinical investigator not to interfere with the outcome of the study.
- Existence of any surgical or medical condition which, in the judgment of the clinical investigator, might interfere with the absorption, distribution, metabolism, or excretion of the drug.
- Presence or history of allergy requiring treatment. Hay fever is allowed unless it is active or has required treatment within the previous 2 months.
- Donation or loss of greater than 400 mL of blood in the period 0 to 12 weeks before entry to the study.
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- Serious adverse reaction or hypersensitivity to any drug.
- Presence or history of any pulmonary diseases (e.g., asthma, emphysema, chronic bronchitis, cystic fibrosis, bronchiectasis).
- Consumption of drugs and/or herbal preparations capable of inducing hepatic enzyme metabolism (e.g., barbiturates, rifampicin, carbamazepine, phenytoin, primidone, or St. John's Wort) or enzyme-inhibiting agents (e.g., cimetidine) or similar drugs within 30 days (or 5 half-lives of inducing/inhibiting agent, whichever is longer) of enrollment in this study.
- Major surgery within 6 months of the start of this study.
- Subjects who have experienced a significant upper or lower respiratory tract infection within the 6 weeks prior to admission.
- Subjects with significant history of respiratory, renal, hepatic, cardiovascular (including history of systemic hypertension requiring therapy), metabolic, neurological, hematological, gastrointestinal, cerebrovascular, or other significant medical illness or disorder which, in the judgment of the investigator, may interfere with the study or require treatment which may affect the evaluation of efficacy and safety of the study drug.
- Subjects with elevated liver enzyme concentrations at Screening and at Day -1.
- Hemoglobin level < 130 g/L taken at Screening and at Day -1.
- Serum potassium > 5 mEq/L taken at Screening and at Day -1.
- Poor venous access.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety, Tolerability, and Pharmacokinetics of GS-9411 in Healthy Male Volunteers
The purpose of this study is to evaluate the safety and tolerability of escalating doses of GS-9411 in healthy male volunteers. GS-9411 is a sodium channel inhibitor, that may restore airway hydration and mucociliary clearance in the lung.
Read the detailed description
GS-9411 is being evaluated as a potential therapy to improve airway hydration and mucociliary clearance in patients with cystic fibrosis. This study is evaluating the safety and tolerability of 4 dose levels of GS-9411 as an inhaled product, compared to a matched placebo.
- Conditions
- Cystic Fibrosis, Mucociliary Clearance, Airway Hydration
- Being tested
- GS-9411, Placebo
- Keywords
- Cystic Fibrosis, CF, Mucociliary Clearance, Epithelial Sodium Channel Inhibitor, ENaC Inhibitor, Airway Hydration, Amiloride
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GS-9411Drug
Inhaled GS-9411 dissolved in sterile saline
PlaceboDrug
Inhaled placebo in sterile saline
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | GS-9411 2.4 mg Receives: Drug: GS-9411 |
| 2 | Experimental | GS-9411 4.8 mg Receives: Drug: GS-9411 |
| 3 | Experimental | GS-9411 7.2 mg Receives: Drug: GS-9411 |
| 4 | Experimental | GS-9411 9.6 mg Receives: Drug: GS-9411 |
| 5 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of 4 escalating doses of GS-9411 in healthy male volunteers
Measured: 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2009
- Study completionSep 2009
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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Peter Hodsman, MD, Principal investigator, Nucleus Network Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00951522
- Sponsor's protocol ID
- GS-US-221-0102
- Status last verified
- Sep 2009
- First submitted
- 3 Aug 2009
- Last updated
- 25 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety, Tolerability, and Pharmacokinetics of GS-9411 in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT00951522
- Acronym / sponsor ID
- GS-US-221-0102
- Conditions
- Cystic Fibrosis, Mucociliary Clearance, Airway Hydration
- Keywords
- Cystic Fibrosis, CF, Mucociliary Clearance, Epithelial Sodium Channel Inhibitor, ENaC Inhibitor, Airway Hydration, Amiloride
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 4 Aug 2009 (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.
The purpose of this study is to evaluate the safety and tolerability of escalating doses of GS-9411 in healthy male volunteers. GS-9411 is a sodium channel inhibitor, that may restore airway hydration and mucociliary clearance in the lung.
Detailed description
GS-9411 is being evaluated as a potential therapy to improve airway hydration and mucociliary clearance in patients with cystic fibrosis. This study is evaluating the safety and tolerability of 4 dose levels of GS-9411 as an inhaled product, compared to a matched placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: GS-9411GS-9411 2.4 mg |
| 2 | Experimental | Drug: GS-9411GS-9411 4.8 mg |
| 3 | Experimental | Drug: GS-9411GS-9411 7.2 mg |
| 4 | Experimental | Drug: GS-9411GS-9411 9.6 mg |
| 5 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Males 18 to 45 years of age
- No clinically important abnormal physical findings at the screening examination
- No clinically relevant abnormalities in the results of laboratory screening evaluation
- Normal (or abnormal but not clinically significant) ECG
- Normal (or abnormal but not clinically significant) blood pressure (BP) and heart rate(HR).
Key exclusion criteria (16 listed)
- Any prior exposure to GS-9411.
- Administration of any investigational drug in the period 0 to 12 weeks before entry to the study.
- A need for any medication during the period 0 to 5 days before entry to the study, except those deemed by the principal investigator/clinical investigator not to interfere with the outcome of the study.
- Existence of any surgical or medical condition which, in the judgment of the clinical investigator, might interfere with the absorption, distribution, metabolism, or excretion of the drug.
- Presence or history of allergy requiring treatment. Hay fever is allowed unless it is active or has required treatment within the previous 2 months.
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-9411Inhaled GS-9411 dissolved in sterile saline | Drug | 1, 2, 3, 4 |
| PlaceboInhaled placebo in sterile saline | Drug | 5 |
Primary outcome
Safety and Tolerability of 4 escalating doses of GS-9411 in healthy male volunteers
Time frame: 7 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2009.
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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.
Peter Hodsman, MD principal investigator
Nucleus Network Ltd
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-9411 in people with Cystic Fibrosis and Mucociliary Clearance, run by Gilead Sciences at 1 site in Australia.
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 15 inclusion and 16 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: finished, as of the sponsor's last update on 25 Sep 2009. 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 Australia. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety and Tolerability of 4 escalating doses of GS-9411 in healthy male volunteers (time frame: 7 Days). 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 25 Sep 2009.