Avian Influenza A VirusPhase 1SEA002NCT00439530
Pharmacologic Study of Oseltamivir in Healthy Volunteers
A Phase 1 study testing oseltamivir and probenecid in people with Avian Influenza A Virus, run by Mahidol University at 1 site in Thailand.
Trial summary
"Pharmacologic Study of Oseltamivir in Healthy Volunteers" is a Phase I study in which 8 to 32 adult healthy Thai volunteers will be randomized to one of four drug doses and regimens within each of 4 visits. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Avian Influenza A Virus
- What is being tested?
- oseltamivir and probenecid
- How many people
- 21 participants
- Where
- 1 siteThailand
- Study dates
- Nov 2006to Apr 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy with no underlying chronic disease
- normal baseline laboratory screening
- no regular prescribed medication used in the past 30 days and no over-the-counter medication in the past week
- agree to abstain from self-medication during the study
- negative urine pregnancy test for females and agreement that they will not try to become pregnant until 1 month after the study is completed
- only use non-hormonal methods of contraception for females
Show all 9Show fewer
- non-smoker for the last 30 days and for duration of the study
- no consumption of alcohol for the last 30 days and for duration of the study
- no use of recreational drugs for the last 30 days and for duration of the study
Who cannot join
- known hypersensitivity to oseltamivir and/or probenecid
- Hepatitis B virus surface antigen positive
- presence of intercurrent illness or any condition which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Bangkok Hospital for Tropical Diseases Research Unit, Faculty of Tropical Medicine, Mahidol University
Bangkok, 10400
About this study
"Pharmacologic Study of Oseltamivir in Healthy Volunteers" is a Phase I study in which 8 to 32 adult healthy Thai volunteers will be randomized to one of four drug doses and regimens within each of 4 visits. The study is being conducted at the Bangkok Hospital of Tropical Diseases Research Unit, Faculty of Tropical Medicine, and commenced enrolling healthy volunteers on 23 November 2006. The duration of the study is expected to be approximately four months. The goals of this study are to assess the use of loading dose oseltamivir and the concomitant use of probenecid and to characterize the pharmacokinetic properties of oseltamivir in Thai subjects.
- Conditions
- Avian Influenza A Virus
- Being tested
- oseltamivir, probenecid
- Keywords
- oseltamivir, pharmacokinetics, probenecid, avian influenza
- Medical subject headings
- Influenza in Birds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oseltamivirDrug
probenecidDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC 0-12 hrs.
Measured: 12 hour
Secondary outcomes (4)
AUC 12-24 hrs.
Measured: 24 hrs
C max
Measured: 24 hrs
t max
Measured: 24 hrs
t 1/2
Measured: 24 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2007 (estimated)
- Study startNov 2006
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Avian Influenza A VirusStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Southeast Asia Influenza Clinical Research Network
- Investigators
- Yupaporn Wattanagoon, DTM & H, Principal investigator, Associate Professor, Department of Clinical Tropical Medicine Faculty of Tropical Medicine, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00439530
- Sponsor's protocol ID
- SEA Trial 0002
- Other IDs
- SEA ICRN
- Acronym
- SEA002
- Status last verified
- Nov 2006
- First submitted
- 21 Feb 2007
- Last updated
- 28 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacologic Study of Oseltamivir in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00439530
- Acronym / sponsor ID
- SEA002 / SEA Trial 0002
- Conditions
- Avian Influenza A Virus
- Keywords
- oseltamivir, pharmacokinetics, probenecid, avian influenza
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Southeast Asia Influenza Clinical Research Network
- Study start
- Nov 2006
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 23 Feb 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.
"Pharmacologic Study of Oseltamivir in Healthy Volunteers" is a Phase I study in which 8 to 32 adult healthy Thai volunteers will be randomized to one of four drug doses and regimens within each of 4 visits. The study is being conducted at the Bangkok Hospital of Tropical Diseases Research Unit, Faculty of Tropical Medicine, and commenced enrolling healthy volunteers on 23 November 2006. The duration of the study is expected to be approximately four months. The goals of this study are to assess the use of loading dose oseltamivir and the concomitant use of probenecid and to characterize the pharmacokinetic properties of oseltamivir in Thai subjects.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- healthy with no underlying chronic disease
- normal baseline laboratory screening
- no regular prescribed medication used in the past 30 days and no over-the-counter medication in the past week
- agree to abstain from self-medication during the study
- negative urine pregnancy test for females and agreement that they will not try to become pregnant until 1 month after the study is completed
Key exclusion criteria (3 listed)
- known hypersensitivity to oseltamivir and/or probenecid
- Hepatitis B virus surface antigen positive
- presence of intercurrent illness or any condition which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study
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 | Drug | – |
| probenecid | Drug | – |
Primary outcome
AUC 0-12 hrs.
Time frame: 12 hour
4 secondary outcomes
AUC 12-24 hrs.
Time frame: 24 hrs
C max
Time frame: 24 hrs
t max
Time frame: 24 hrs
t 1/2
Time frame: 24 hrs
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 28 Jul 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.
Yupaporn Wattanagoon, DTM & H principal investigator
Associate Professor, Department of Clinical Tropical Medicine Faculty of Tropical Medicine, Mahidol University
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 oseltamivir and probenecid in people with Avian Influenza A Virus, run by Mahidol University at 1 site in Thailand.
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 9 inclusion and 3 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 28 Jul 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 Thailand. 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?
AUC 0-12 hrs. (time frame: 12 hour). 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 28 Jul 2009.