Influenza A Virus, H1N1 SubtypePhase 1NAI113625NCT00989404
Crossover Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Repeat Dose Zanamivir/Placebo Via Devices Administered Twice Daily for 5 Days
A Phase 1 study testing Zanamivir in people with Influenza A Virus, H1N1 Subtype, run by GlaxoSmithKline at 1 site in United States.
Trial summary
The purpose of this study is to compare the safety and tolerability of Zanamivir using a Rotahaler device presentation to placebo within the Rotahaler presentation and to the Diskhaler device. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza A Virus, H1N1 Subtype
- What is being tested?
- Zanamivir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2009to 7 Dec 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subject is healthy as judged by a responsible physician with no clinically significant abnormality identified on a medical evaluation
- Male and female volunteers from 18-55 years of age, inclusively, at the time of signing the informed consent.
- A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea or Child-bearing potential and agrees to use one of the contraception methods listed in the protocol for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point.
- Male subjects must agree to use one of the contraception methods listed in the protocol.
- Nonsmokers defined as abstinence from cigarette smoking for the previous 12 months before enrollment into the study.
- Body mass Index of 19-30 kg/m2.
- FEV1 greater than or equal to 85 percent of the predicted and FEV1/FVC ratio greater than or equal to 0.7 at screening.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Who cannot join
- The subject has a positive pre-study urine drug/ alcohol screen.
- Significant pulmonary disease, such as chronic obstructive pulmonary disease, asthma, or other pulmonary diseases that may affect the pulmonary disposition of study drug or pose a safety risk for oral inhaled study drug.
- Subjects with symptoms of upper respiratory infections at study entry.
- Subjects currently presenting with chronic upper or lower respiratory tract infection, allergic rhinitis, hay fever, or sinusitis.
- Significant psychiatric disease, such as anxiety disorders or psychotic disorders.
- A creatinine clearance less than 70mL/min
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- History of regular alcohol consumption within 6 months of the study as defined in the protocol
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer)
- Exposure to more than four experimental medications within 12 months prior to the first dosing day.
- Ingestion of alcohol, grapefruit juice or grapefruit products, caffeine-containing food or beverage with 48 hours prior to the first dose of study medication and continuing through study completion.
- Subjects who have donated blood to the extent where participation in the study would result in excess of 500mL blood donated within a 56 day period.
- History of sensitivity to any of the study medications, or components thereof (including lactose) or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation. In addition, if heparin is used during pharmacokinetic sampling, subjects with a history of sensitivity to heparin or heparin-induced thrombocytopenia should not be enrolled.
- Those who, in the opinion of the investigator, have a risk of non-compliance with study procedures.
- Lack of suitability for participation in this study, for any reason, in the opinion of the investigator.
- Subjects who, after training, are unable to use the study related devices.
- The subject's systolic blood pressure is outside the range of 90-140mmHg, or diastolic blood pressure is outside the range of 45-90mmHg or heart rate is outside the range of 50-100bpm for female subjects or 45-100 bpm for male subjects.
Trial locations and contacts
1 site in 1 country.
United States1 site
GSK Investigational Site
Minneapolis, Minnesota, 55404
About this study
Official title: A Randomized, Placebo Controlled, 3-Way Crossover Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Repeat Dose Zanamivir/Placebo 10mg Administered Twice Daily for 5 Days by a Rotahaler Compared to the Diskhaler in Healthy Subjects
The purpose of this study is to compare the safety and tolerability of Zanamivir using a Rotahaler device presentation to placebo within the Rotahaler presentation and to the Diskhaler device.
Read the detailed description
The purpose of this study is to compare the safety and tolerability of Zanamivir using a Rotahaler to placebo within the Rotahaler presentation and to the Diskhaler. Eighteen subjects will receive each of three treatments for 5 days in a 3-way crossover design.
- Conditions
- Influenza A Virus, H1N1 Subtype
- Being tested
- Zanamivir
- Keywords
- pk, healthy subjects, influenza virus, Safety, pandemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZanamivirDrug
Rotahaler placebo 10mg BID 5 days
ZanamivirDrug
Rotahaler Zanamivir 10mg BID 5 days
ZanamivirDrug
Diskhaler Zanamivir 10mg BID 5 days
| Study group | Role | What they receive |
|---|---|---|
| Period | Experimental | 10 mg BID Zanamivir or placebo for 5 days Receives: Drug: Zanamivir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability: AEs, Labs, Vitals
Measured: Nineteen days
Secondary outcomes (1)
Pharmacokinetic parameters per protocol
Measured: Five days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2009 (estimated)
- Study start12 Oct 2009
- Primary completion7 Dec 2009
- Study completion7 Dec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Influenza A Virus, H1N1 SubtypeStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00989404
- Sponsor's protocol ID
- 113625
- Acronym
- NAI113625
- Status last verified
- Jun 2017
- First submitted
- 24 Sep 2009
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
Weller S, Jones LS, Lou Y, Piscitelli S, Peppercorn A, Ng-Cashin J. Safety, tolerability and pharmacokinetics of orally inhaled zanamivir: a randomized study comparing Rotacap/Rotahaler and Rotadisk/Diskhaler in healthy adults. Antivir Ther. 2013;18(6):827-30. doi: 10.3851/IMP2631. Epub 2013 May 21.
PubMed 23696221
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo Controlled, 3-Way Crossover Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Repeat Dose Zanamivir/Placebo 10mg Administered Twice Daily for 5 Days by a Rotahaler Compared to the Diskhaler in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00989404
- Acronym / sponsor ID
- NAI113625 / 113625
- Conditions
- Influenza A Virus, H1N1 Subtype
- Keywords
- pk, healthy subjects, influenza virus, Safety, pandemic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2009 (actual)
- Primary completion
- 7 Dec 2009 (actual)
- Study completion
- 7 Dec 2009 (actual)
- First posted
- 5 Oct 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 compare the safety and tolerability of Zanamivir using a Rotahaler device presentation to placebo within the Rotahaler presentation and to the Diskhaler device.
Detailed description
The purpose of this study is to compare the safety and tolerability of Zanamivir using a Rotahaler to placebo within the Rotahaler presentation and to the Diskhaler. Eighteen subjects will receive each of three treatments for 5 days in a 3-way crossover design.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Period | Experimental | Drug: Zanamivir10 mg BID Zanamivir or placebo for 5 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- The subject is healthy as judged by a responsible physician with no clinically significant abnormality identified on a medical evaluation
- Male and female volunteers from 18-55 years of age, inclusively, at the time of signing the informed consent.
- A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea or Child-bearing potential and agrees to use one of the contraception methods listed in the protocol for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point.
- Male subjects must agree to use one of the contraception methods listed in the protocol.
- Nonsmokers defined as abstinence from cigarette smoking for the previous 12 months before enrollment into the study.
Key exclusion criteria (17 listed)
- The subject has a positive pre-study urine drug/ alcohol screen.
- Significant pulmonary disease, such as chronic obstructive pulmonary disease, asthma, or other pulmonary diseases that may affect the pulmonary disposition of study drug or pose a safety risk for oral inhaled study drug.
- Subjects with symptoms of upper respiratory infections at study entry.
- Subjects currently presenting with chronic upper or lower respiratory tract infection, allergic rhinitis, hay fever, or sinusitis.
- Significant psychiatric disease, such as anxiety disorders or psychotic disorders.
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 |
|---|---|---|
| ZanamivirRotahaler placebo 10mg BID 5 days | Drug | Period |
| ZanamivirRotahaler Zanamivir 10mg BID 5 days | Drug | Period |
| ZanamivirDiskhaler Zanamivir 10mg BID 5 days | Drug | Period |
Primary outcome
Safety and Tolerability: AEs, Labs, Vitals
Time frame: Nineteen days
1 secondary outcome
Pharmacokinetic parameters per protocol
Time frame: Five 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 14 Jun 2017.
- Background: PubMed 23696221Weller S, Jones LS, Lou Y, Piscitelli S, Peppercorn A, Ng-Cashin J. Safety, tolerability and pharmacokinetics of orally inhaled zanamivir: a randomized study comparing Rotacap/Rotahaler and Rotadisk/Diskhaler in healthy adults. Antivir Ther. 2013;18(6):827-30. doi: 10.3851/IMP2631. Epub 2013 May 21.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Results for study 113625 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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.
GSK Clinical Trials study director
GlaxoSmithKline
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 Zanamivir in people with Influenza A Virus, H1N1 Subtype, run by GlaxoSmithKline 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 8 inclusion and 17 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 14 Jun 2017. 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 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: AEs, Labs, Vitals (time frame: Nineteen days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00989404, which also lists 1 linked publication.
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 14 Jun 2017.