InfluenzaPhase 1/2FAVORNCT01728753
T-705a Multicenter Study in Adults Subjects With Uncomplicated Influenza
A Phase 1/2 study testing Favipiravir in people with Influenza, run by MDVI, LLC at 1 site in United States.
Trial summary
This is safety and pharmacokinetics (PK) of favipiravir study in adults 18-80 years of age diagnosed with uncomplicated influenza. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Influenza
- What is being tested?
- Favipiravir
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 550 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Feb 2013
- Phase
- Phase 1/2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Understand the requirements of the study and has provided written informed consent prior to undergoing any study-related procedures.
- Is male or female between the ages of 18 and 80 years old, inclusive.
- Tests positive for influenza A or B by a commercially available Rapid Antigen Test (RAT) -OR- Has influenza confirmed by diagnostic assay (e.g. non-study RAT or PCR) from another clinic during the 48 hours between onset of symptoms and anticipated dosing.
- (Note: A subject with a negative RAT result may still enroll if the Medical Monitor and Investigator agree that there is a known influenza outbreak circulating in the community or the subject has been in close contact with a person who was recently confirmed to have influenza by RAT or another lab test).
- Has a fever, defined for subjects ≥18 but ≤65 years old as a temperature (oral) of 100.4°F (38.0°C) or more; subjects >65 years old with a temperature (oral) of 100.0°F (37.8°C) or more at the first visit or in the 6 hours prior if antipyretics were taken before the visit.
- If male, subject must:
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- Be sterile (have had a vasectomy at least 6 months prior to Day 1 dosing and had sperm counts verifying that he is no longer fertile) OR b. Agree he will not donate sperm during the study and for 3 months following the last dose of study medication, and c. Will strictly adhere to the following contraceptive measures for 3 months after the last dose of study medication: i. Abstain from sexual intercourse or; ii. Use a condom during sexual intercourse with a female of child-bearing potential. In addition to the male condom, the female partner must use another form of contraception (e.g. intrauterine device (IUD), diaphragm with spermicide, oral contraceptives, injectable progesterone, or subdermal implants) for at least 3 months following Day 1 dosing).
- If female, subject must:
- Be unable to bear children (have not had a period for ≥12 consecutive months, have had her uterus or ovaries removed, or have had a tubal ligation) OR b. Have a male partner incapable of fathering a child (has had a vasectomy at least 6 months prior to study entry and has had sperm counts verifying that he is no longer fertile) OR c. Have a negative urine pregnancy test at screening AND d. Not have had unprotected sex within the last month AND e. If she is of childbearing potential, will strictly adhere to the following contraceptive measures during the study and for 3 months following the last dose of study medication: i. Abstain from sexual intercourse or ii. Her male partner agrees to use a condom during sexual intercourse AND iii. She agrees to use an approved method of contraception (e.g., IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, or subdermal implants).
- Has 2 or more of the following symptoms (moderate to severe in intensity) at the time of enrollment that began 48 hours or less prior to first dose:
- Cough
- Sore throat
- Headache
- Nasal congestion
- Body aches and pains
- Fatigue
- Influenza Symptom Intensity:
- 0: None
- Mild, Symptoms are tolerable, possible to perform daily activities
- Moderate, Symptoms are disturbing, partially interfere with daily activities
- Severe, Symptoms are intolerable, impossible to perform daily activities
Who cannot join
- Has taken an anti-influenza drug (e.g., amantadine hydrochloride, rimantadine, oseltamivir phosphate, zanamivir hydrate, or peramivir) or live vaccination within 4 weeks prior to signing of the informed consent.
- Has underlying chronic respiratory disease (e.g., Chronic Obstructive Pulmonary Disease (COPD), chronic bronchitis, diffuse panbronchiolitis, bronchiectasis, pulmonary emphysema, pulmonary fibrosis, bronchial asthma, or active tuberculosis).
- At the beginning of the study, is suspected of having bacterial respiratory infection (i.e., expectoration of purulent or mucopurulent sputum and/or infiltrate in lung in a chest x-ray, or is on antibiotics for lung disease).
- Has a history of gout or is under treatment for gout or hyperuricemia.
- Has hereditary xanthinuria.
- Has a history of hypouricemia (under 1 mg/dL) or xanthine calculi of the urinary tract.
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- Has a history of hypersensitivity to an anti-viral nucleoside-analog drug targeting a viral RNA polymerase.
- Is using adrenocorticosteroids, except topical preparations, or immunosuppressive drugs (e.g., immunosuppressants, anticancer drugs).
- Has an allergy to acetaminophen or has a contraindication for acetaminophen.
- Has a serious chronic disease (e.g., HIV, cancer requiring chemotherapy within the preceding 6 months, moderate or severe hepatic insufficiency and/or unstable renal, cardiac, pulmonary, neurologic, vascular, or endocrinologic disease states requiring medication dose adjustments within the last 30 days).
- Has previously received favipiravir (T-705a).
- Has renal insufficiency requiring hemodialysis or central auditory processing disorder (CAPD).
- Has a Class II or greater cardiac impairment defined by the New York Heart Association (NYHA)Functional Classification.
- Has a history of alcohol or drug abuse in the preceding 2 years.
- Has a psychiatric disease that is not well controlled (not on a stable regimen for greater than one year)
- Has taken another investigational drug within 30 days prior to signing the informed consent.
- Is deemed by the Investigator to be ineligible for any reason.
- Is employed by or is related to an employee of the clinical study site.
- Female patients who are pregnant, breast-feeding, or have a positive urine pregnancy test at Visit 1.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double Blind,Placebo-Controlled, Multicenter Study Evaluating the Safety and Pharmacokinetics of Different Dosing Regimens of Favipiravir in Healthy Adult Subjects and Adult Subjects With Uncomplicated Influenza
This is safety and pharmacokinetics (PK) of favipiravir study in adults 18-80 years of age diagnosed with uncomplicated influenza.
- Conditions
- Influenza
- Being tested
- Placebo, Favipiravir
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo BID x 1 day, and Placebo BID x 4 days; Placebo TID x 1 day, and Placebo TID x 4 days
FavipiravirDrug
1200 mg TID on Day 1, then 600 mg TID on Days 2-5
FavipiravirDrug
2400 mg loading dose followed by 600 mg + 600 mg on Day 1, then 600 mg TID on Days 2-5
FavipiravirDrug
1800 mg BID on Day 1, then 800mg BID for Days 2 5
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| T-705 A | Experimental | Favipiravir regimen 1: 1200 mg 3x daily (TID) on Day 1, then 600 mg TID on Days 2-5 Receives: Drug: Favipiravir |
| T-705 B | Experimental | Favipiravir regimen 2: 2400 mg loading dose followed by 600 mg + 600 mg on Day 1, then 600 mg TID on Days 2-5 Receives: Drug: Favipiravir |
| T-705 C | Experimental | Favipiravir regimen 3: 1800 mg BID on Day 1, then 800 mg BID for Days 2-5 Receives: Drug: Favipiravir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of favipiravir
Measured: Post-dose on Days 1 and 5: 1, 2, 4, 9, 10, and 12 hours
Area Under the Curve (AUC) of favipiravir
Measured: Post-dose on Days 1 and 5: 1, 2, 4, 9, 10, and 12 hours
Secondary outcomes (2)
time to alleviation of influenza symptoms
Measured: 15 days
Adverse Event[AE]
The following information will be recorded: AE, time of onset, time of resolution (or note if ongoing), duration of event, severity, relationship to trial medication, use of concomitant medication, and/or other action taken, and action taken with study medication.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionFeb 2013
- Study completionFeb 2013
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 InfluenzaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 550 participants (actual)
Sponsor and investigators
- Lead sponsor
- MDVI, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Jason M Hafizullah, MD, Principal investigator, Sunrise Medical Research, Lauderdale Lakes, FL 33319Susan Hole, D.O., Principal investigator, Riverside Clinical Research, Edgewater, FL 32132Richard L. Beasley, MD, Principal investigator, Health Concepts, Rapid City, SD 57702Jay H Sandberg, DO, Principal investigator, Oakland Medical Research Center, Troy, MI 48085Edgardo A. Osea, MD, Principal investigator, Holy Trinity Medical Clinic, Harbor City, CA 90710Shawn N. Gentry, MD, Principal investigator, HCCA Clinical Research Solutions, Columbia, TN 38401Stephen K. Smith, MD, Principal investigator, Burke Primary Care, Morganton, NC 28655Roberto Sotolongo, MD, Principal investigator, Research Institute of South Florida, Inc., Miami, FL 33173
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01728753
- Sponsor's protocol ID
- T705aUS213
- Acronym
- FAVOR
- Status last verified
- Sep 2015
- First submitted
- 9 Nov 2012
- Last updated
- 21 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hayden FG, Lenk RP, Epstein C, Kang LL. Oral Favipiravir Exposure and Pharmacodynamic Effects in Adult Outpatients With Acute Influenza. J Infect Dis. 2024 Aug 16;230(2):e395-e404. doi: 10.1093/infdis/jiad409.
PubMed 37739792
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double Blind,Placebo-Controlled, Multicenter Study Evaluating the Safety and Pharmacokinetics of Different Dosing Regimens of Favipiravir in Healthy Adult Subjects and Adult Subjects With Uncomplicated Influenza
- ClinicalTrials.gov ID
- NCT01728753
- Acronym / sponsor ID
- FAVOR / T705aUS213
- Conditions
- Influenza
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 550 participants (actual)
- Lead sponsor
- MDVI, LLCIndustry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Study start
- Nov 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 20 Nov 2012 (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 is safety and pharmacokinetics (PK) of favipiravir study in adults 18-80 years of age diagnosed with uncomplicated influenza.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| T-705 A | Experimental | Drug: FavipiravirFavipiravir regimen 1: 1200 mg 3x daily (TID) on Day 1, then 600 mg TID on Days 2-5 |
| T-705 B | Experimental | Drug: FavipiravirFavipiravir regimen 2: 2400 mg loading dose followed by 600 mg + 600 mg on Day 1, then 600 mg TID on Days 2-5 |
| T-705 C | Experimental | Drug: FavipiravirFavipiravir regimen 3: 1800 mg BID on Day 1, then 800 mg BID for Days 2-5 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Understand the requirements of the study and has provided written informed consent prior to undergoing any study-related procedures.
- Is male or female between the ages of 18 and 80 years old, inclusive.
- Tests positive for influenza A or B by a commercially available Rapid Antigen Test (RAT) -OR- Has influenza confirmed by diagnostic assay (e.g. non-study RAT or PCR) from another clinic during the 48 hours between onset of symptoms and anticipated dosing.
- (Note: A subject with a negative RAT result may still enroll if the Medical Monitor and Investigator agree that there is a known influenza outbreak circulating in the community or the subject has been in close contact with a person who was recently confirmed to have influenza by RAT or another lab test).
- Has a fever, defined for subjects ≥18 but ≤65 years old as a temperature (oral) of 100.4°F (38.0°C) or more; subjects >65 years old with a temperature (oral) of 100.0°F (37.8°C) or more at the first visit or in the 6 hours prior if antipyretics were taken before the visit.
Key exclusion criteria (19 listed)
- Has taken an anti-influenza drug (e.g., amantadine hydrochloride, rimantadine, oseltamivir phosphate, zanamivir hydrate, or peramivir) or live vaccination within 4 weeks prior to signing of the informed consent.
- Has underlying chronic respiratory disease (e.g., Chronic Obstructive Pulmonary Disease (COPD), chronic bronchitis, diffuse panbronchiolitis, bronchiectasis, pulmonary emphysema, pulmonary fibrosis, bronchial asthma, or active tuberculosis).
- At the beginning of the study, is suspected of having bacterial respiratory infection (i.e., expectoration of purulent or mucopurulent sputum and/or infiltrate in lung in a chest x-ray, or is on antibiotics for lung disease).
- Has a history of gout or is under treatment for gout or hyperuricemia.
- Has hereditary xanthinuria.
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 |
|---|---|---|
| PlaceboPlacebo BID x 1 day, and Placebo BID x 4 days; Placebo TID x 1 day, and Placebo TID x 4 days | Drug | Placebo |
| Favipiravir1200 mg TID on Day 1, then 600 mg TID on Days 2-5 | Drug | T-705 A |
| Favipiravir2400 mg loading dose followed by 600 mg + 600 mg on Day 1, then 600 mg TID on Days 2-5 | Drug | T-705 B |
| Favipiravir1800 mg BID on Day 1, then 800mg BID for Days 2 5 | Drug | T-705 C |
Primary outcome
Cmax of favipiravir
Time frame: Post-dose on Days 1 and 5: 1, 2, 4, 9, 10, and 12 hours
Area Under the Curve (AUC) of favipiravir
Time frame: Post-dose on Days 1 and 5: 1, 2, 4, 9, 10, and 12 hours
2 secondary outcomes
time to alleviation of influenza symptoms
Time frame: 15 days
Adverse Event[AE]
Time frame: 15 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 21 Oct 2015.
- Derived from this study: PubMed 37739792Hayden FG, Lenk RP, Epstein C, Kang LL. Oral Favipiravir Exposure and Pharmacodynamic Effects in Adult Outpatients With Acute Influenza. J Infect Dis. 2024 Aug 16;230(2):e395-e404. doi: 10.1093/infdis/jiad409.
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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.
Jason M Hafizullah, MD principal investigator
Sunrise Medical Research, Lauderdale Lakes, FL 33319
Susan Hole, D.O. principal investigator
Riverside Clinical Research, Edgewater, FL 32132
Richard L. Beasley, MD principal investigator
Health Concepts, Rapid City, SD 57702
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Favipiravir in people with Influenza, run by MDVI, LLC 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 21 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 21 Oct 2015. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Cmax of favipiravir (time frame: Post-dose on Days 1 and 5: 1, 2, 4, 9, 10, and 12 hours). The study lists 2 primary outcomes in all. 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 NCT01728753, 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 21 Oct 2015.