HealthyPhase 1NCT01049763
Open-Label Pharmacokinetic of Oseltamivir in Healthy Obese Thai Adult Subjects
A Phase 1 study testing oseltamivir in people with Healthy, run by South East Asia Infectious Disease Clinical Research Network at 1 site in Thailand.
Trial summary
This study is planned to characterize the pharmacokinetic properties of oseltamivir and the active product--oseltamivir carboxylate--in obesity in order to provide clinical guidance for the optimum oseltamivir treatment regimens for severe influenza. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- oseltamivir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2010to Oct 2010
- 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 as judged by a responsible physician with no abnormality identified on a medical evaluation including medical history and physical examination.
- Males and Females aged between 18 years to 60 years.
- BMI >30 kg/ m2 (BMI = body weight [BW] (kg)/height (m2)) for obese group, BMI 18-24.9 kg/ m2 (BMI = BW (kg)/height (m2)) for control group.
- A female is eligible to enter and participate in this study if she is:
- of non-childbearing potential including pre-menopausal females with documented (medical report verification) hysterectomy or double oophorectomy
- or postmenopausal defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum follicle stimulating hormone levels >40 mIU/mL or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy
Show all 12Show fewer
- or of childbearing potential, has a negative serum pregnancy test at screening and prior to start the study drug in each period, and abstain from sexual intercourse or agrees to using effective contraceptive methods during the study until completion of the follow-up procedures
- A male is eligible to enter and participate in this study if he: agrees to abstain from (or use a condom during) sexual intercourse with females of childbearing potential or lactating females; or is willing to use a condom/spermicide, during the study until completion of the follow-up procedures.
- Read, comprehend, and write at a sufficient level to complete study-related materials.
- Provide a signed and dated written informed consent prior to study participation.
- Normal electrocardiogram (ECG) with QTc <450 msec.
- Willingness and ability to comply with the study protocol for the duration of the trial.
Who cannot join
- Females who are pregnant, trying to get pregnant, or are lactating.
- The subject has evidence of active substance abuse that may compromise safety, pharmacokinetics, or ability to adhere with protocol instructions.
- A positive pre-study hepatitis B surface antigen, positive hepatitis C antibody, or positive human immunodeficiency virus-1 (HIV-1) antibody result at screening.
- Subjects with a personal history of cardiac disease, symptomatic or asymptomatic arrhythmias, syncopal episodes, or additional risk factors for torsades de points (heart failure, hypokalemia).
- Subjects with a family history of sudden cardiac death.
- A creatinine clearance <70 mL/min as determined by Cockcroft-Gault equation:
Show all 19Show fewer
- CLcr (mL/min) = (140 - age) Wt / (72 Scr) (multiply answer by 0.85 for females). Where age is in years, weight (wt) is in kg, and serum creatinine (Scr) is in units of mg/dL [Cockcroft, 1976].
- History of alcohol or substance abuse or dependence within 6 months of the study: History of regular alcohol consumption averaging >7 drinks/wk for women or >14 drinks/wk for men. One drink is equivalent to 12 g alcohol = 5 oz (150 mL) of wine or 12 oz (360 mL) of beer or 1.5 oz (45 mL) of 80 proof distilled spirits within 6 months of screening.
- Use of prescription or non-prescription drugs except paracetamol at doses of up to 2 grams/day, including vitamins, herbal and dietary supplements 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 until the completion of the follow-up procedure.
- Use of live attenuated influenza vaccine, inactivated influenza vaccine, or any other antiinfluenza antiviral medications within 14 days prior to the first dose of investigational product.
- The subject has participated in a clinical trial and has received a drug or a new chemical entity within 30 days or 5 half lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of study medication.
- The subject is unwilling to abstain from ingesting alcohol within 48 hours prior to the first dose of study medication until collection of the final pharmacokinetic sample during each regimen.
- Subjects who have donated blood to the extent that participation in the study would result in more than 300 mL blood donated within a 30-day period.
- Subjects who have a history of allergy to the study drug or drugs of this class, or a history of drug or other allergy that, in the opinion of the investigator, contraindicates participation in the trial. 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.
- Subjects with unstable medical conditions that, in the opinion of the investigator would compromise their participation in the trial
- 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.
- AST or ALT >1.5 upper limit of normal (ULN)
- Subjects with history of renal disease, hepatic disease, and/or cholecystectomy
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Mahidol-Oxford Tropical Medicine Research Unit Faculty of Tropical Medicine, Mahidol University Bangkok
Bangkok
About this study
Official title: Phase I, Open-Label Study to Evaluate Potential Pharmacokinetic of Orally Administered Oseltamivir in Healthy Obese Thai Adult Subjects
This study is planned to characterize the pharmacokinetic properties of oseltamivir and the active product--oseltamivir carboxylate--in obesity in order to provide clinical guidance for the optimum oseltamivir treatment regimens for severe influenza. It is also a prompt response to a new era influenza plan along with recognition of growing numbers of obese persons.
The study findings will be available for a future management plan in dealing with this virus that is transmitted easily from person to person and has shown substantial antigenic changes over time.
The primary focus of statistical analysis is to verify the effect of obesity on oseltamivir/oseltamivir carboxylate pharmacokinetics as measured by oseltamivir carboxylate Cmax, AUC (0-12), AUC (0-24), C12, λz, and t1/2 and oseltamivir Cmax, AUC (0-12), and C12.
Read the detailed description
This is an open-label, cross-over, randomized pharmacokinetic study conducted in approximately 12 obese and 12 non obese adult subjects at one study center in Thailand.
Subjects will receive 2 regimens in a random sequence for 2 visits.
- Regimen A; 75 mg single dose.
- Regimen B; 150 mg single dose. All dosing will be supervised and documented. Subjects will have 2 hospitalizations to complete visit 2 and visit 3 in their assigned sequence within each. Each visit will require hospitalization for about 40 hours (2 nights and 2 days). The subject will be randomized to receive either regimen A or B on first admission (visit 2). Treatment allocation will be performed using computer-generated list of random permutations of AB sequence.
Subjects who received regimen A will receive regimen B on second admission and vice versa, with more than 3 days wash out period in between. Subjects will return to the study centre for a follow-up visit 7-10 days after completing the last dosing assessments or withdrawing from the study. The total duration of study participation will be approximately 4 weeks from screening through follow-up.
Assessment of the safety profile will be done after each admission by the investigating team before proceeding to the other regimen.
- Conditions
- Healthy
- Being tested
- oseltamivir
- Keywords
- obese adult, non obese healthy volunteers, oseltamivir carboxylate, pharmacokinetics, healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oseltamivirDrug
oseltamivir 150 mg single oral dose oseltamivir 75 mg single oral dose
| Study group | Role | What they receive |
|---|---|---|
| Regimen A | Experimental | oseltamivir 75 mg single dose Receives: Drug: oseltamivir |
| Regimen B | Active comparator | oseltamivir 150 mg single dose Receives: Drug: oseltamivir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oseltamivir carboxylate maximum concentration (OC Cmax) and area under the concentration curve 0-12h (OC AUC(0-12))
Measured: 12 hours
Secondary outcomes (1)
Oseltamivir maximum concentration at 12 hours (OS C12) Oseltamivir carboxylate area under the concentration curve 0-24 hours AUC(0-24)), concentration at 24 hours (C24), elimination rate constant (OC-λz), and elimination half life (t1/2)
Measured: 1 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionSep 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- South East Asia Infectious Disease Clinical Research Network
- Sponsor type
- Research network
- Collaborators
- University of Oxford
- Investigators
- Podjanee Jittmala, MD, Principal investigator, Mahidol-Oxford Tropical Medicine Research Unit Faculty of Tropical Medicine, Mahidol UniversitySasithon Pukrittayakamee, Professor, Study chair, Mahidol UniversityPratap Singhasivanon, A/Professor, Study chair, Mahidol UniversityNick White, Professor, Study chair, Mahidol-Oxford Tropical Medicine Research Unit Faculty of Tropical Medicine, Mahidol University Bangkok, ThailandNick Day, Professor, Study chair, Mahidol-Oxford Tropical Medicine Research Unit Faculty of Tropical Medicine, Mahidol University Bangkok, ThailandNiklas Lindegardh, A/Professor, Study chair, Clinical Pharmacology Laboratory Faculty of Tropical Medicine, Mahidol University Bangkok, ThailandBob Taylor, MD, Study chair, Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University Bangkok, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01049763
- Sponsor's protocol ID
- SEA 131
- Status last verified
- Oct 2010
- First submitted
- 13 Jan 2010
- Last updated
- 8 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ward P, Small I, Smith J, Suter P, Dutkowski R. Oseltamivir (Tamiflu) and its potential for use in the event of an influenza pandemic. J Antimicrob Chemother. 2005 Feb;55 Suppl 1:i5-i21. doi: 10.1093/jac/dki018.
PubMed 15709056Tran TH, Nguyen TL, Nguyen TD, Luong TS, Pham PM, Nguyen vV, Pham TS, Vo CD, Le TQ, Ngo TT, Dao BK, Le PP, Nguyen TT, Hoang TL, Cao VT, Le TG, Nguyen DT, Le HN, Nguyen KT, Le HS, Le VT, Christiane D, Tran TT, Menno de J, Schultsz C, Cheng P, Lim W, Horby P, Farrar J; World Health Organization International Avian Influenza Investigative Team. Avian influenza A (H5N1) in 10 patients in Vietnam. N Engl J Med. 2004 Mar 18;350(12):1179-88. doi: 10.1056/NEJMoa040419. Epub 2004 Feb 25.
PubMed 14985470Chotpitayasunondh T, Ungchusak K, Hanshaoworakul W, Chunsuthiwat S, Sawanpanyalert P, Kijphati R, Lochindarat S, Srisan P, Suwan P, Osotthanakorn Y, Anantasetagoon T, Kanjanawasri S, Tanupattarachai S, Weerakul J, Chaiwirattana R, Maneerattanaporn M, Poolsavathitikool R, Chokephaibulkit K, Apisarnthanarak A, Dowell SF. Human disease from influenza A (H5N1), Thailand, 2004. Emerg Infect Dis. 2005 Feb;11(2):201-9. doi: 10.3201/eid1102.041061.
PubMed 15752436Treanor JJ, Hayden FG, Vrooman PS, Barbarash R, Bettis R, Riff D, Singh S, Kinnersley N, Ward P, Mills RG. Efficacy and safety of the oral neuraminidase inhibitor oseltamivir in treating acute influenza: a randomized controlled trial. US Oral Neuraminidase Study Group. JAMA. 2000 Feb 23;283(8):1016-24. doi: 10.1001/jama.283.8.1016.
PubMed 10697061Hayden FG, Treanor JJ, Fritz RS, Lobo M, Betts RF, Miller M, Kinnersley N, Mills RG, Ward P, Straus SE. Use of the oral neuraminidase inhibitor oseltamivir in experimental human influenza: randomized controlled trials for prevention and treatment. JAMA. 1999 Oct 6;282(13):1240-6. doi: 10.1001/jama.282.13.1240.
PubMed 10517426Hayden FG, Atmar RL, Schilling M, Johnson C, Poretz D, Paar D, Huson L, Ward P, Mills RG. Use of the selective oral neuraminidase inhibitor oseltamivir to prevent influenza. N Engl J Med. 1999 Oct 28;341(18):1336-43. doi: 10.1056/NEJM199910283411802.
PubMed 10536125de Jong MD, Tran TT, Truong HK, Vo MH, Smith GJ, Nguyen VC, Bach VC, Phan TQ, Do QH, Guan Y, Peiris JS, Tran TH, Farrar J. Oseltamivir resistance during treatment of influenza A (H5N1) infection. N Engl J Med. 2005 Dec 22;353(25):2667-72. doi: 10.1056/NEJMoa054512.
PubMed 16371632Yen HL, Ilyushina NA, Salomon R, Hoffmann E, Webster RG, Govorkova EA. Neuraminidase inhibitor-resistant recombinant A/Vietnam/1203/04 (H5N1) influenza viruses retain their replication efficiency and pathogenicity in vitro and in vivo. J Virol. 2007 Nov;81(22):12418-26. doi: 10.1128/JVI.01067-07. Epub 2007 Sep 12.
PubMed 17855542Yen HL, Monto AS, Webster RG, Govorkova EA. Virulence may determine the necessary duration and dosage of oseltamivir treatment for highly pathogenic A/Vietnam/1203/04 influenza virus in mice. J Infect Dis. 2005 Aug 15;192(4):665-72. doi: 10.1086/432008. Epub 2005 Jul 15.
PubMed 16028136Cockshott WP, Thompson GT, Howlett LJ, Seeley ET. Intramuscular or intralipomatous injections? N Engl J Med. 1982 Aug 5;307(6):356-8. doi: 10.1056/NEJM198208053070607. No abstract available.
PubMed 7088101Ritschel WA, Kaul S. Prediction of apparent volume of distribution in obesity. Methods Find Exp Clin Pharmacol. 1986 Apr;8(4):239-47.
PubMed 3724300Abernethy DR, Greenblatt DJ. Drug disposition in obese humans. An update. Clin Pharmacokinet. 1986 May-Jun;11(3):199-213. doi: 10.2165/00003088-198611030-00002.
PubMed 3524955Beckel MH. Factor affecting the storage of drug and other xenobiotics in adipose tissue. Adv Drug Res 1994; 25: 55-86.
Benedek IH, Blouin RA, McNamara PJ. Serum protein binding and the role of increased alpha 1-acid glycoprotein in moderately obese male subjects. Br J Clin Pharmacol. 1984 Dec;18(6):941-6. doi: 10.1111/j.1365-2125.1984.tb02567.x.
PubMed 6529534Caraco Y, Zylber-Katz E, Berry EM, Levy M. Antipyrine disposition in obesity: evidence for negligible effect of obesity on hepatic oxidative metabolism. Eur J Clin Pharmacol. 1995;47(6):525-30. doi: 10.1007/BF00193706.
PubMed 7768256
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Open-Label Study to Evaluate Potential Pharmacokinetic of Orally Administered Oseltamivir in Healthy Obese Thai Adult Subjects
- ClinicalTrials.gov ID
- NCT01049763
- Acronym / sponsor ID
- SEA 131
- Conditions
- Healthy
- Keywords
- obese adult, non obese healthy volunteers, oseltamivir carboxylate, pharmacokinetics, healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- South East Asia Infectious Disease Clinical Research NetworkResearch network
- Collaborators
- University of Oxford
- Study start
- Jan 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 14 Jan 2010 (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 planned to characterize the pharmacokinetic properties of oseltamivir and the active product--oseltamivir carboxylate--in obesity in order to provide clinical guidance for the optimum oseltamivir treatment regimens for severe influenza. It is also a prompt response to a new era influenza plan along with recognition of growing numbers of obese persons.
The study findings will be available for a future management plan in dealing with this virus that is transmitted easily from person to person and has shown substantial antigenic changes over time.
The primary focus of statistical analysis is to verify the effect of obesity on oseltamivir/oseltamivir carboxylate pharmacokinetics as measured by oseltamivir carboxylate Cmax, AUC (0-12), AUC (0-24), C12, λz, and t1/2 and oseltamivir Cmax, AUC (0-12), and C12.
Detailed description
This is an open-label, cross-over, randomized pharmacokinetic study conducted in approximately 12 obese and 12 non obese adult subjects at one study center in Thailand.
Subjects will receive 2 regimens in a random sequence for 2 visits.
- Regimen A; 75 mg single dose.
- Regimen B; 150 mg single dose. All dosing will be supervised and documented. Subjects will have 2 hospitalizations to complete visit 2 and visit 3 in their assigned sequence within each. Each visit will require hospitalization for about 40 hours (2 nights and 2 days). The subject will be randomized to receive either regimen A or B on first admission (visit 2). Treatment allocation will be performed using computer-generated list of random permutations of AB sequence.
Subjects who received regimen A will receive regimen B on second admission and vice versa, with more than 3 days wash out period in between. Subjects will return to the study centre for a follow-up visit 7-10 days after completing the last dosing assessments or withdrawing from the study. The total duration of study participation will be approximately 4 weeks from screening through follow-up.
Assessment of the safety profile will be done after each admission by the investigating team before proceeding to the other regimen.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regimen A | Experimental | Drug: oseltamiviroseltamivir 75 mg single dose |
| Regimen B | Active comparator | Drug: oseltamiviroseltamivir 150 mg single dose |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Healthy as judged by a responsible physician with no abnormality identified on a medical evaluation including medical history and physical examination.
- Males and Females aged between 18 years to 60 years.
- BMI >30 kg/ m2 (BMI = body weight [BW] (kg)/height (m2)) for obese group, BMI 18-24.9 kg/ m2 (BMI = BW (kg)/height (m2)) for control group.
- A female is eligible to enter and participate in this study if she is:
- A male is eligible to enter and participate in this study if he: agrees to abstain from (or use a condom during) sexual intercourse with females of childbearing potential or lactating females; or is willing to use a condom/spermicide, during the study until completion of the follow-up procedures.
Key exclusion criteria (19 listed)
- Females who are pregnant, trying to get pregnant, or are lactating.
- The subject has evidence of active substance abuse that may compromise safety, pharmacokinetics, or ability to adhere with protocol instructions.
- A positive pre-study hepatitis B surface antigen, positive hepatitis C antibody, or positive human immunodeficiency virus-1 (HIV-1) antibody result at screening.
- Subjects with a personal history of cardiac disease, symptomatic or asymptomatic arrhythmias, syncopal episodes, or additional risk factors for torsades de points (heart failure, hypokalemia).
- Subjects with a family history of sudden cardiac death.
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 |
|---|---|---|
| oseltamiviroseltamivir 150 mg single oral dose oseltamivir 75 mg single oral dose | Drug | Regimen A, Regimen B |
Primary outcome
Oseltamivir carboxylate maximum concentration (OC Cmax) and area under the concentration curve 0-12h (OC AUC(0-12))
Time frame: 12 hours
1 secondary outcome
Oseltamivir maximum concentration at 12 hours (OS C12) Oseltamivir carboxylate area under the concentration curve 0-24 hours AUC(0-24)), concentration at 24 hours (C24), elimination rate constant (OC-λz), and elimination half life (t1/2)
Time frame: 1 weeks
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 8 Oct 2010.
- Background: PubMed 15709056Ward P, Small I, Smith J, Suter P, Dutkowski R. Oseltamivir (Tamiflu) and its potential for use in the event of an influenza pandemic. J Antimicrob Chemother. 2005 Feb;55 Suppl 1:i5-i21. doi: 10.1093/jac/dki018.
- Background: PubMed 14985470Tran TH, Nguyen TL, Nguyen TD, Luong TS, Pham PM, Nguyen vV, Pham TS, Vo CD, Le TQ, Ngo TT, Dao BK, Le PP, Nguyen TT, Hoang TL, Cao VT, Le TG, Nguyen DT, Le HN, Nguyen KT, Le HS, Le VT, Christiane D, Tran TT, Menno de J, Schultsz C, Cheng P, Lim W, Horby P, Farrar J; World Health Organization International Avian Influenza Investigative Team. Avian influenza A (H5N1) in 10 patients in Vietnam. N Engl J Med. 2004 Mar 18;350(12):1179-88. doi: 10.1056/NEJMoa040419. Epub 2004 Feb 25.
- Background: PubMed 15752436Chotpitayasunondh T, Ungchusak K, Hanshaoworakul W, Chunsuthiwat S, Sawanpanyalert P, Kijphati R, Lochindarat S, Srisan P, Suwan P, Osotthanakorn Y, Anantasetagoon T, Kanjanawasri S, Tanupattarachai S, Weerakul J, Chaiwirattana R, Maneerattanaporn M, Poolsavathitikool R, Chokephaibulkit K, Apisarnthanarak A, Dowell SF. Human disease from influenza A (H5N1), Thailand, 2004. Emerg Infect Dis. 2005 Feb;11(2):201-9. doi: 10.3201/eid1102.041061.
- Background: PubMed 10697061Treanor JJ, Hayden FG, Vrooman PS, Barbarash R, Bettis R, Riff D, Singh S, Kinnersley N, Ward P, Mills RG. Efficacy and safety of the oral neuraminidase inhibitor oseltamivir in treating acute influenza: a randomized controlled trial. US Oral Neuraminidase Study Group. JAMA. 2000 Feb 23;283(8):1016-24. doi: 10.1001/jama.283.8.1016.
- Background: PubMed 10517426Hayden FG, Treanor JJ, Fritz RS, Lobo M, Betts RF, Miller M, Kinnersley N, Mills RG, Ward P, Straus SE. Use of the oral neuraminidase inhibitor oseltamivir in experimental human influenza: randomized controlled trials for prevention and treatment. JAMA. 1999 Oct 6;282(13):1240-6. doi: 10.1001/jama.282.13.1240.
- Background: PubMed 10536125Hayden FG, Atmar RL, Schilling M, Johnson C, Poretz D, Paar D, Huson L, Ward P, Mills RG. Use of the selective oral neuraminidase inhibitor oseltamivir to prevent influenza. N Engl J Med. 1999 Oct 28;341(18):1336-43. doi: 10.1056/NEJM199910283411802.
- Background: PubMed 16371632de Jong MD, Tran TT, Truong HK, Vo MH, Smith GJ, Nguyen VC, Bach VC, Phan TQ, Do QH, Guan Y, Peiris JS, Tran TH, Farrar J. Oseltamivir resistance during treatment of influenza A (H5N1) infection. N Engl J Med. 2005 Dec 22;353(25):2667-72. doi: 10.1056/NEJMoa054512.
- Background: PubMed 17855542Yen HL, Ilyushina NA, Salomon R, Hoffmann E, Webster RG, Govorkova EA. Neuraminidase inhibitor-resistant recombinant A/Vietnam/1203/04 (H5N1) influenza viruses retain their replication efficiency and pathogenicity in vitro and in vivo. J Virol. 2007 Nov;81(22):12418-26. doi: 10.1128/JVI.01067-07. Epub 2007 Sep 12.
- Background: PubMed 16028136Yen HL, Monto AS, Webster RG, Govorkova EA. Virulence may determine the necessary duration and dosage of oseltamivir treatment for highly pathogenic A/Vietnam/1203/04 influenza virus in mice. J Infect Dis. 2005 Aug 15;192(4):665-72. doi: 10.1086/432008. Epub 2005 Jul 15.
- Background: PubMed 7088101Cockshott WP, Thompson GT, Howlett LJ, Seeley ET. Intramuscular or intralipomatous injections? N Engl J Med. 1982 Aug 5;307(6):356-8. doi: 10.1056/NEJM198208053070607. No abstract available.
- Background: PubMed 3724300Ritschel WA, Kaul S. Prediction of apparent volume of distribution in obesity. Methods Find Exp Clin Pharmacol. 1986 Apr;8(4):239-47.
- Background: PubMed 3524955Abernethy DR, Greenblatt DJ. Drug disposition in obese humans. An update. Clin Pharmacokinet. 1986 May-Jun;11(3):199-213. doi: 10.2165/00003088-198611030-00002.
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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.
Podjanee Jittmala, MD principal investigator
Mahidol-Oxford Tropical Medicine Research Unit Faculty of Tropical Medicine, Mahidol University
Sasithon Pukrittayakamee, Professor study chair
Mahidol University
Pratap Singhasivanon, A/Professor study chair
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 in people with Healthy, run by South East Asia Infectious Disease Clinical Research Network 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 12 inclusion and 19 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 8 Oct 2010. 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?
Oseltamivir carboxylate maximum concentration (OC Cmax) and area under the concentration curve 0-12h (OC AUC(0-12)) (time frame: 12 hours). 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 NCT01049763, which also lists 19 linked publications.
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 8 Oct 2010.