Healthy SubjectsPhase 1NCT00540501
A Study to Evaluate Orally-Administered Oseltamivir and Intravenous Zanamivir in Healthy Subjects
A Phase 1 study testing Oseltamivir and Intravenous Zanamivir in people with Healthy Subjects, run by GlaxoSmithKline.
Trial summary
This study is a 4 period study to see if there is any interaction between Orally-Administered Oseltamivir and Intravenous Zanamivir in Healthy Thai Adult Subjects Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Oseltamivir and Intravenous Zanamivir
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2007to Oct 2007
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Volunteer(s)confirmed by physical exam, clinical labs, ECGs, and vitals
- Must be woman of non-childbearing potential or willing to abstain from intercourse for two weeks prior to study drug administration and throughout the study or be willing to use two acceptable methods of birth control.
Who cannot join
- Subjects with history of certain heart problems or subjects with Hepatitis B, C or HIV.
About this study
Official title: Phase 1, Open-Label Study to Evaluate Potential Pharmacokinetic Interactions Between Orally-Administered Oseltamivir and Intravenous Zanamivir in Healthy Thai Adult Subjects
This study is a 4 period study to see if there is any interaction between Orally-Administered Oseltamivir and Intravenous Zanamivir in Healthy Thai Adult Subjects
- Conditions
- Healthy Subjects
- Being tested
- Oseltamivir and Intravenous Zanamivir
- Keywords
- zanamivir,, influenza virus,, healthy volunteer,, PK, drug interaction,, IV, and oseltamivir.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oseltamivir and Intravenous ZanamivirDrug
Oseltamivir will be administered PO q12h for 3 days (for a total of 5 doses ending the morning of day 3.
Both drugs will be administered simultaneously starting on Day 1 of Period 3. Zanamivir will be administered IV q12h for 3 days (for a total of 5 doses ending on the morning of day 3.
Zanamivir to be given four (4) hours after the oral dose of oseltamivir and infused over 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Oseltamivir 150mg and zanamivir 50mg/hour | Experimental | Oseltamivir1 150mg PO q12h for 5 doses + Zanamivir IV continuous infusion at 50mg/hour for 72 hours Receives: Drug: Oseltamivir and Intravenous Zanamivir |
| Zanamivir IV 50mg/hour | Experimental | Zanamivir IV continuous infusion 50mg/hour for 16 hours (total dose of 800mg) Receives: Drug: Oseltamivir and Intravenous Zanamivir |
| Oseltamivir 150mg and zanamivir 600mg | Experimental | Oseltamivir 150mg PO q12h for 5 doses + Zanamivir 600mg IV q12h Receives: Drug: Oseltamivir and Intravenous Zanamivir |
| Oseltamivir 150mg | Active comparator | Oseltamivir 150mg PO q12h for 3 days Receives: Drug: Oseltamivir and Intravenous Zanamivir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oseltamivir carboxylate levels: Cmax and AUC(0-12)-
Measured: Period 2: Day 1, 2 & 3. Period 3: Day 1, 2 & 3. Period 4: Day 1, 2 & 3.
Secondary outcomes (3)
Oseltamivir: Cmax, AUC(0-12)& C12. Oseltamivir carboxylate: C12, AUC(0-24)& t1/2.
Measured: Period 2-4 Day 1-3
Zanamivir: Cmax, AUC(0-12), C12, t1/2, CL, tmax & V2 .
Measured: Period 1, 3 & 4 Day 1-3
Safety:labs, vitals, ECGs & AEs.
Measured: Period 1-4, Days 1-4.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionOct 2007 (estimated)
- Study completionOct 2007 (estimated)
Why it stopped: Contract agreement not reached
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00540501
- Sponsor's protocol ID
- NAI108166
- Status last verified
- May 2010
- First submitted
- 4 Oct 2007
- Last updated
- 31 May 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Open-Label Study to Evaluate Potential Pharmacokinetic Interactions Between Orally-Administered Oseltamivir and Intravenous Zanamivir in Healthy Thai Adult Subjects
- ClinicalTrials.gov ID
- NCT00540501
- Acronym / sponsor ID
- NAI108166
- Conditions
- Healthy Subjects
- Keywords
- zanamivir,, influenza virus,, healthy volunteer,, PK, drug interaction,, IV, and oseltamivir.
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Contract agreement not reached
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Oct 2007 (estimated)
- Study completion
- Oct 2007 (estimated)
- First posted
- 8 Oct 2007 (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 study is a 4 period study to see if there is any interaction between Orally-Administered Oseltamivir and Intravenous Zanamivir in Healthy Thai Adult Subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Oseltamivir 150mg and zanamivir 50mg/hour | Experimental | Drug: Oseltamivir and Intravenous ZanamivirOseltamivir1 150mg PO q12h for 5 doses + Zanamivir IV continuous infusion at 50mg/hour for 72 hours |
| Zanamivir IV 50mg/hour | Experimental | Drug: Oseltamivir and Intravenous ZanamivirZanamivir IV continuous infusion 50mg/hour for 16 hours (total dose of 800mg) |
| Oseltamivir 150mg and zanamivir 600mg | Experimental | Drug: Oseltamivir and Intravenous ZanamivirOseltamivir 150mg PO q12h for 5 doses + Zanamivir 600mg IV q12h |
| Oseltamivir 150mg | Active comparator | Drug: Oseltamivir and Intravenous ZanamivirOseltamivir 150mg PO q12h for 3 days |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy Volunteer(s)confirmed by physical exam, clinical labs, ECGs, and vitals
- Must be woman of non-childbearing potential or willing to abstain from intercourse for two weeks prior to study drug administration and throughout the study or be willing to use two acceptable methods of birth control.
Key exclusion criteria (1 listed)
- Subjects with history of certain heart problems or subjects with Hepatitis B, C or HIV.
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 |
|---|---|---|
| Oseltamivir and Intravenous ZanamivirOseltamivir will be administered PO q12h for 3 days (for a total of 5 doses ending the morning of day 3. Both drugs will be administered simultaneously starting on Day 1 of Period 3. Zanamivir will be administered IV q12h for 3 days (for a total of 5 doses ending on the morning of day 3. Zanamivir to be given four (4) hours after the oral dose of oseltamivir and infused over 30 minutes. | Drug | Oseltamivir 150mg, Oseltamivir 150mg and zanamivir 50mg/hour, Oseltamivir 150mg and zanamivir 600mg, Zanamivir IV 50mg/hour |
Primary outcome
Oseltamivir carboxylate levels: Cmax and AUC(0-12)-
Time frame: Period 2: Day 1, 2 & 3. Period 3: Day 1, 2 & 3. Period 4: Day 1, 2 & 3.
3 secondary outcomes
Oseltamivir: Cmax, AUC(0-12)& C12. Oseltamivir carboxylate: C12, AUC(0-24)& t1/2.
Time frame: Period 2-4 Day 1-3
Zanamivir: Cmax, AUC(0-12), C12, t1/2, CL, tmax & V2 .
Time frame: Period 1, 3 & 4 Day 1-3
Safety:labs, vitals, ECGs & AEs.
Time frame: Period 1-4, Days 1-4.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2010.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oseltamivir and Intravenous Zanamivir in people with Healthy Subjects, run by GlaxoSmithKline.
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 2 inclusion and 1 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: withdrawn, as of the sponsor's last update on 31 May 2010. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Oseltamivir carboxylate levels: Cmax and AUC(0-12)- (time frame: Period 2: Day 1, 2 & 3. Period 3: Day 1, 2 & 3. Period 4: Day 1, 2 & 3.). 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 31 May 2010.