InfluenzaPhase 1NCT00297050
Safety and Dose Study of Peramivir for Influenza Treatment
A Phase 1 study testing Peramivir in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
This study will evaluate the safety and tolerability of peramivir, a new drug to treat influenza. The study will administer gradually increasing doses of the drug in successive small groups of subjects to determine the optimal dose that is safe and well tolerated. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Influenza
- What is being tested?
- Peramivir
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2006to 14 Nov 2006
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age greater than or equal to 18 years and less than or equal to 50 years.
- Weight greater than or equal to 50 kg (110 lbs).
- Body mass index (BMI) of 19-32 kg/m(2).
- Subjects must agree to:
- Not take any prescription or OTC medications with the exception of Tylenol, and contraceptive medications for a period of 7 days prior and during study drug administration.
- Not consume any alcohol for a period of 2 days prior and during study drug administration.
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- Not receive a live attenuated influenza vaccine (Flumist) for 7 days prior to study drug administration, through day 14 (which will be at least 8 days from the last dose of study drug).
- Not participate in any other research protocol between screening, and the last day of follow-up.
- 5. Females of child-bearing potential must (one of the following):
- Be surgically sterile.
- Be abstinent (or willing to be) 4 weeks prior to date of screening evaluation through 4 weeks after study drug administration.
- Use oral contraceptives, or other form of hormonal birth control including hormonal vaginal rings or transdermal patches, and have been using these for three months prior through 4 weeks after study drug administration.
- Use an intra-uterine device (IUD) as birth control 4 weeks prior to date of screening evaluation through 4 weeks after study drug administration.
- Use (by ensuring her male partner(s) uses) barrier contraception (condom) with a spermacide as birth control 4 weeks prior to date of screening evaluation through 4 weeks after study drug administration.
Who cannot join
- Any chronic medical problem that requires daily oral medications (except Tylenol and oral contraceptives), or other medical history that in the opinion of the investigator significantly increases the risk associated with a Phase I drug.
- History of cardiovascular disease or unexplained syncope
- Family history of sudden death in a first degree relative.
- Women who are breast-feeding.
- Positive urine or serum pregnancy test.
- Abnormal ECG (defined as any baseline Grade 1 or greater toxicity by the toxicity table for ECG. The toxicity table specifically evaluates PR interval, QTc interval and rhythm. Asymptomatic sinus bradycardia, especially in a subject that exercises, is acceptable).
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- Abnormal chemistry panel (defined as any baseline Grade 1 or greater toxicity from the Chem 20 panel evaluating only sodium, potassium, total CO2 (bicarbonate), creatinine, glucose, urea nitrogen, total calcium, total magnesium, phosphorus, alkaline phosphatase, ALT, AST, total bilirubin, direct bilirubin, LDH, total protein, total CK, uric acid).
- Abnormal complete blood count (CBC) (defined as any baseline Grade 1 or greater toxicity from the CBC evaluating only the WBC, hemoglobin, hematocrit, and platelets).
- Abnormal urinalysis (defined as any baseline Grade 1 or greater toxicity from the urinalysis evaluating only protein, and RBCs).
- Positive serology for Hepatitis B surface antigen.
- Positive serology for Hepatitis C.
- Positive serology for HIV-1.
- Positive urine drug screen.
- Participation in a study of any investigational drug within the last 30 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: A Phase I Double-Blind, Placebo-Controlled, Dose-Escalating Study to Evaluate the Safety and Tolerability of Intravenous Peramivir in Healthy Subjects
This study will evaluate the safety and tolerability of peramivir, a new drug to treat influenza. The study will administer gradually increasing doses of the drug in successive small groups of subjects to determine the optimal dose that is safe and well tolerated. It will be studied first at a single dose and then in multiple doses. The study will also determine how long peramivir stays in the body and how high the drug levels are in the blood.
Men and women 18 - 40 years of age who weigh at least 110 lbs. and have a body mass index (BMI) between 19 and 32 may be eligible for this study. Candidates are screened with a medical history, physical examination, electrocardiogram (EKG), and blood and urine tests.
Read more
Part I - Single Dose Escalation
Participants are admitted to the NIH hospital for 32 to 40 hours for a single 15-minute intravenous infusion of peramivir or placebo (saline), followed by monitoring and evaluation. The drug dose is increased in successive groups of eight subjects; in each group, six subjects are given peramivir and two receive placebo. The first group receives 0.5 mg/kg of peramivir; subsequent groups receive increasingly higher doses (1, 2, 3.5, and 5 mg/kg) as long as the last dose was well tolerated by the preceding group. Blood samples are drawn and subjects are monitored for vital signs (temperature, blood pressure and heart rate) and for symptoms such as headache, nausea, shortness of breath or pain at 0.5, 1, 2, 3, 6, 9, 12, 18 and 24 hours after the drug infusion. At the 24-hour evaluation they have an EKG. If needed, an echocardiogram (ultrasound examination of the heart) may also be done. Subjects return to the clinic 2, 3, 7, 14, and 28 days after the infusion for a check of vital signs, review of symptoms, blood draw, and urine sample collection. In addition, subjects are asked to collect all their urine for the first 48 hours after the study drug infusion.
Part II - Multi-dose Escalation
Groups of 16 subjects receive an intravenous infusion of peramivir (12 subject) or placebo (4 subjects) once a day for 5 consecutive days. The first four infusions are given in the NIH outpatient clinic. The dose of peramivir is increased in successive groups of 16 subjects as long as the preceding dose was well tolerated. Before the infusion on day 1, subjects have a physical examination, blood test and EKG to obtain baseline values. After the infusion, they remain in the hospital for 6 hours. Vital signs and symptoms are c...
Read the detailed description
Human influenza is a serious disease causing over 30,000 deaths in the United States each year, and avian influenza presents a threat of a future pandemic. Despite this burden of current and potential disease, there are no parenteral treatments for influenza, and currently, the most common treatment (oseltamivir) is expensive and complex to manufacture.
The primary purpose of this protocol is to evaluate the safety and tolerability of intravenous peramivir, a neuraminidase inhibitor. Beginning with a low single-dose, the safety and tolerability is established by evaluating symptoms, clinical laboratory tests, ECG, and pharmacokinetics. Utilizing a series of stopping rules and a medical monitor, the dose will be escalated as safety and tolerability are established. Once the maximum tolerated dose (MTD) is established in the first part of this trial (either limited by adverse effects or up to maximum anticipated dose), the safety and tolerability of multi-dose administration will begin (replicating anticipated clinical use). These cohorts will be evaluated using similar criteria. The dose used in the multi-dose cohorts will also be escalated as safety and tolerability are established.
- Conditions
- Influenza
- Being tested
- Peramivir
- Keywords
- Influenza Virus, Avian Influenza, Normal Volunteers, Neuraminidase Inhibitor, Viral Disease, Healthy Volunteer, HV
- Medical subject headings
- Influenza, Human, Influenza in Birds, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PeramivirDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2006 (estimated)
- Study start23 Feb 2006
- Primary completion14 Nov 2006
- Study completion14 Nov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Enrolment
- 100 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00297050
- Sponsor's protocol ID
- 060105
- Other IDs
- 06-I-0105
- Status last verified
- 5 Aug 2009
- First submitted
- 25 Feb 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Cox NJ, Subbarao K. Influenza. Lancet. 1999 Oct 9;354(9186):1277-82. doi: 10.1016/S0140-6736(99)01241-6.
PubMed 10520648Thompson WW, Shay DK, Weintraub E, Brammer L, Cox N, Anderson LJ, Fukuda K. Mortality associated with influenza and respiratory syncytial virus in the United States. JAMA. 2003 Jan 8;289(2):179-86. doi: 10.1001/jama.289.2.179.
PubMed 12517228Beigel JH, Farrar J, Han AM, Hayden FG, Hyer R, de Jong MD, Lochindarat S, Nguyen TK, Nguyen TH, Tran TH, Nicoll A, Touch S, Yuen KY; Writing Committee of the World Health Organization (WHO) Consultation on Human Influenza A/H5. Avian influenza A (H5N1) infection in humans. N Engl J Med. 2005 Sep 29;353(13):1374-85. doi: 10.1056/NEJMra052211. No abstract available.
PubMed 16192482
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Double-Blind, Placebo-Controlled, Dose-Escalating Study to Evaluate the Safety and Tolerability of Intravenous Peramivir in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00297050
- Acronym / sponsor ID
- 060105
- Conditions
- Influenza
- Keywords
- Influenza Virus, Avian Influenza, Normal Volunteers, Neuraminidase Inhibitor, Viral Disease, Healthy Volunteer, HV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 23 Feb 2006
- Primary completion
- 14 Nov 2006 (actual)
- Study completion
- 14 Nov 2006 (actual)
- First posted
- 27 Feb 2006 (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 will evaluate the safety and tolerability of peramivir, a new drug to treat influenza. The study will administer gradually increasing doses of the drug in successive small groups of subjects to determine the optimal dose that is safe and well tolerated. It will be studied first at a single dose and then in multiple doses. The study will also determine how long peramivir stays in the body and how high the drug levels are in the blood.
Men and women 18 - 40 years of age who weigh at least 110 lbs. and have a body mass index (BMI) between 19 and 32 may be eligible for this study. Candidates are screened with a medical history, physical examination, electrocardiogram (EKG), and blood and urine tests.
Part I - Single Dose Escalation
Participants are admitted to the NIH hospital for 32 to 40 hours for a single 15-minute intravenous infusion of peramivir or placebo (saline), followed by monitoring and evaluation. The drug dose is increased in successive groups of eight subjects; in each group, six subjects are given peramivir and two receive placebo. The first group receives 0.5 mg/kg of peramivir; subsequent groups receive increasingly higher doses (1, 2, 3.5, and 5 mg/kg) as long as the last dose was well tolerated by the preceding group. Blood samples are drawn and subjects are monitored for vital signs (temperature, blood pressure and heart rate) and for symptoms such as headache, nausea, shortness of breath or pain at 0.5, 1, 2, 3, 6, 9, 12, 18 and 24 hours after the drug infusion. At the 24-hour evaluation they have an EKG. If needed, an echocardiogram (ultrasound examination of the heart) may also be done. Subjects return to the clinic 2, 3, 7, 14, and 28 days after the infusion for a check of vital signs, review of symptoms, blood draw, and urine sample collection. In addition, subjects are asked to collect all their urine for the first 48 hours after the study drug infusion.
Part II - Multi-dose Escalation
Groups of 16 subjects receive an intravenous infusion of peramivir (12 subject) or placebo (4 subjects) once a day for 5 consecutive days. The first four infusions are given in the NIH outpatient clinic. The dose of peramivir is increased in successive groups of 16 subjects as long as the preceding dose was well tolerated. Before the infusion on day 1, subjects have a physical examination, blood test and EKG to obtain baseline values. After the infusion, they remain in the hospital for 6 hours. Vital signs and symptoms are c...
Detailed description
Human influenza is a serious disease causing over 30,000 deaths in the United States each year, and avian influenza presents a threat of a future pandemic. Despite this burden of current and potential disease, there are no parenteral treatments for influenza, and currently, the most common treatment (oseltamivir) is expensive and complex to manufacture.
The primary purpose of this protocol is to evaluate the safety and tolerability of intravenous peramivir, a neuraminidase inhibitor. Beginning with a low single-dose, the safety and tolerability is established by evaluating symptoms, clinical laboratory tests, ECG, and pharmacokinetics. Utilizing a series of stopping rules and a medical monitor, the dose will be escalated as safety and tolerability are established. Once the maximum tolerated dose (MTD) is established in the first part of this trial (either limited by adverse effects or up to maximum anticipated dose), the safety and tolerability of multi-dose administration will begin (replicating anticipated clinical use). These cohorts will be evaluated using similar criteria. The dose used in the multi-dose cohorts will also be escalated as safety and tolerability are established.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Not take any prescription or OTC medications with the exception of Tylenol, and contraceptive medications for a period of 7 days prior and during study drug administration.
- Not consume any alcohol for a period of 2 days prior and during study drug administration.
- Not receive a live attenuated influenza vaccine (Flumist) for 7 days prior to study drug administration, through day 14 (which will be at least 8 days from the last dose of study drug).
- Not participate in any other research protocol between screening, and the last day of follow-up.
- Be surgically sterile.
Key exclusion criteria (14 listed)
- Any chronic medical problem that requires daily oral medications (except Tylenol and oral contraceptives), or other medical history that in the opinion of the investigator significantly increases the risk associated with a Phase I drug.
- History of cardiovascular disease or unexplained syncope
- Family history of sudden death in a first degree relative.
- Women who are breast-feeding.
- Positive urine or serum pregnancy test.
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 |
|---|---|---|
| Peramivir | Drug | – |
Primary outcome
Not reported in the source record.
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 2 Jul 2017.
- Background: PubMed 10520648Cox NJ, Subbarao K. Influenza. Lancet. 1999 Oct 9;354(9186):1277-82. doi: 10.1016/S0140-6736(99)01241-6.
- Background: PubMed 12517228Thompson WW, Shay DK, Weintraub E, Brammer L, Cox N, Anderson LJ, Fukuda K. Mortality associated with influenza and respiratory syncytial virus in the United States. JAMA. 2003 Jan 8;289(2):179-86. doi: 10.1001/jama.289.2.179.
- Background: PubMed 16192482Beigel JH, Farrar J, Han AM, Hayden FG, Hyer R, de Jong MD, Lochindarat S, Nguyen TK, Nguyen TH, Tran TH, Nicoll A, Touch S, Yuen KY; Writing Committee of the World Health Organization (WHO) Consultation on Human Influenza A/H5. Avian influenza A (H5N1) infection in humans. N Engl J Med. 2005 Sep 29;353(13):1374-85. doi: 10.1056/NEJMra052211. No abstract available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Peramivir in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 14 inclusion and 14 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 2 Jul 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00297050, which also lists 3 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 2 Jul 2017.