HealthyPhase 1NCT01419457
Pharmacokinetics of Favipiravir in Volunteers With Hepatic Impairment
A Phase 1 study testing Favipiravir in people with Healthy and Hepatic Impairment, run by MDVI, LLC at 2 sites in United States.
Trial summary
This study is designed to determine the pharmacokinetics of favipiravir in volunteers with hepatic impairment and in healthy control volunteers. Read more about this study
- Who is it for?
- Ages 19 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Hepatic Impairment
- What is being tested?
- Favipiravir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2011to Feb 2013
- 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 19 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hepatically impaired groups:
- Agree to doctor approved birth control methods from Day 1 until 3 months following the final dose of study drug.
- Have mild hepatic impairment (Child-Pugh Clinical Assessment Score Grade A, score 5 6) or moderate hepatic impairment (Child-Pugh Clinical Assessment Score Grade B, score 7-9) or severe hepatic impairment (Child-Pugh Clinical Assessment Score Grade C, score 10-15);
- Control group
- Agree to doctor approved birth control methods from Day 1 until 3 months following the final dose of study drug.
- Healthy as determined by medical history, physical exam, vital signs, ECGs, and clinical laboratory tests.
Who cannot join
- Hepatically impaired groups:
- Have used any drugs known to significantly affect hepatic metabolism within 28 days, or is unable or unwilling to forgo the use of such products throughout the study;
- Have any acute or unstable condition or disease, other than impaired hepatic function, as determined by medical history, physical exam, ECG and clinical laboratory tests;
- Known ongoing alcohol and/or drug abuse within 1 month
- Any evidence of progressive worsening liver function disease as indicated by laboratory values;
- Have had an acute flare of hepatitis A or B within 6 months;
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- Have acute, fulminant alcoholic hepatitis, determined either clinically or by histology;
- Have a history of hepatoma or metastatic disease of the liver;
- Control group:
- Have used any drugs known to significantly affect hepatic metabolism within 28 days, or is unable or unwilling to forgo the use of such products throughout the study;
- Have a history or presence of clinically cardiovascular, dermatologic, endocrine, gastrointestinal, hematologic, hepatic, immunologic, neurologic, oncologic, psychiatric, pulmonary, or renal disease or any other condition.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Miami
Miami, Florida
Orlando Clinical Research Center
Orlando, Florida
About this study
Official title: A Phase I, Open-Label, Parallel-Group, Multiple-Dose Study to Determine the Pharmacokinetics of Favipiravir in Volunteers With Hepatic Impairment and in Healthy Control Volunteers
This study is designed to determine the pharmacokinetics of favipiravir in volunteers with hepatic impairment and in healthy control volunteers.
- Conditions
- Healthy, Hepatic Impairment
- Being tested
- Favipiravir
- Keywords
- Healthy, hepatic impairment, T-705a, Favipiravir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FavipiravirDrug
Also called T-705a
1200 mg BID for Day 1 + 800 mg BID for Day 2-5
FavipiravirDrug
Also called T-705a
800 mg BID for Day 1 + 400 mg BID for Day 2-3
FavipiravirDrug
800 mg Single Dose
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Normal hepatic function Receives: Drug: Favipiravir |
| Group 2 | Experimental | Mild hepatic impairment Receives: Drug: Favipiravir |
| Group 3 | Experimental | Moderate hepatic impairment Receives: Drug: Favipiravir |
| Group 4 | Experimental | Severe hepatic impairment Receives: Drug: Favipiravir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of favipiravir
The PK parameters for favipiravir and its metabolite in hepatically impaired adult subjects relative to healthy adult subjects matched for age, weight, gender, and race status on Day 1 and on Day 5.
Measured: predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 18, 24, 36, 48 hours post-dose on Day 1 and Day 5
AUC of favipiravir
The PK parameters for favipiravir and its metabolite in hepatically impaired adult subjects relative to healthy adult subjects matched for age, weight, gender, and race status on Day 1 and on Day 5.
Measured: predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 18, 24, 36, 48 hours post-dose on Day 1 and Day 5
Secondary outcomes (5)
vital signs
Measured: 13 days
electrocardiograms [ECGs]
Measured: 13 days
clinical laboratory assessment
Measured: 13 days
adverse events [AEs]
Measured: 13 days
physical examination
Measured: 13 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- MDVI, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard A. Preston, MD/MSHP/MBA, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01419457
- Sponsor's protocol ID
- T705aUS109
- Status last verified
- Oct 2015
- First submitted
- 10 Aug 2011
- Last updated
- 22 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Parallel-Group, Multiple-Dose Study to Determine the Pharmacokinetics of Favipiravir in Volunteers With Hepatic Impairment and in Healthy Control Volunteers
- ClinicalTrials.gov ID
- NCT01419457
- Acronym / sponsor ID
- T705aUS109
- Conditions
- Healthy, Hepatic Impairment
- Keywords
- Healthy, hepatic impairment, T-705a, Favipiravir
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- MDVI, LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 18 Aug 2011 (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 designed to determine the pharmacokinetics of favipiravir in volunteers with hepatic impairment and in healthy control volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: FavipiravirNormal hepatic function |
| Group 2 | Experimental | Drug: FavipiravirMild hepatic impairment |
| Group 3 | Experimental | Drug: FavipiravirModerate hepatic impairment |
| Group 4 | Experimental | Drug: FavipiravirSevere hepatic impairment |
Who may qualify
- Ages
- 19 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Hepatically impaired groups:
- Control group
Key exclusion criteria (11 listed)
- Hepatically impaired groups:
- Control group:
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 |
|---|---|---|
| FavipiravirAlso: T-705a1200 mg BID for Day 1 + 800 mg BID for Day 2-5 | Drug | Group 1, Group 2, Group 3 |
| FavipiravirAlso: T-705a800 mg BID for Day 1 + 400 mg BID for Day 2-3 | Drug | Group 1, Group 4 |
| Favipiravir800 mg Single Dose | Drug | Group 4 |
Primary outcome
Cmax of favipiravir
Time frame: predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 18, 24, 36, 48 hours post-dose on Day 1 and Day 5
The PK parameters for favipiravir and its metabolite in hepatically impaired adult subjects relative to healthy adult subjects matched for age, weight, gender, and race status on Day 1 and on Day 5.
AUC of favipiravir
Time frame: predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 18, 24, 36, 48 hours post-dose on Day 1 and Day 5
The PK parameters for favipiravir and its metabolite in hepatically impaired adult subjects relative to healthy adult subjects matched for age, weight, gender, and race status on Day 1 and on Day 5.
5 secondary outcomes
vital signs
Time frame: 13 days
electrocardiograms [ECGs]
Time frame: 13 days
clinical laboratory assessment
Time frame: 13 days
adverse events [AEs]
Time frame: 13 days
physical examination
Time frame: 13 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 22 Oct 2015.
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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.
Richard A. Preston, MD/MSHP/MBA principal investigator
University of Miami
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Favipiravir in people with Healthy and Hepatic Impairment, run by MDVI, LLC at 2 sites 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 6 inclusion and 11 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 22 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 2 sites 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.
What does the primary outcome measure?
Cmax of favipiravir (time frame: predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 18, 24, 36, 48 hours post-dose on Day 1 and Day 5). 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?
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 22 Oct 2015.