Acute Herpes ZosterPhase 1NCT02322957
A Study Investigating the Pharmacokinetics of FV-100 With and Without Ritonavir in Healthy Volunteers
A Phase 1 study testing FV-100 in people with Acute Herpes Zoster, run by ContraVir Pharmaceuticals, Inc..
Trial summary
This study is designed to evaluate the potential for a PK drug-drug interaction between FV-100 and ritonavir. The study is a single-center, open-label, randomized, 2-way crossover design in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Herpes Zoster
- What is being tested?
- FV-100
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Jul 2015
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Capable of giving written informed consent
- Non-tobacco user for at least 3 months prior to selection
- Healthy on the basis of physical examination, medical history, ECG and clinical laboratory testing at screening
Who cannot join
- Infected with Hepatitis A, B, C, or HIV
- History of or any current medical condition which could impact safety of the participant
- A positive urine drug test
- Consumption of more than 2 units of alcoholic beverages per day or more than 14 per week
- Received an investigational drug or vaccine or used an investigational medical device within 3 months or 5 half-lives before the planned start of treatment or prior treatment with FV-100
- Subjects who have used any drugs or substances known to inhibit or induce cytochrome(CYP) P450 enzymes and/or P-gp within 28 days prior to the first dose and throughout study
- Subjects who have, within 2 weeks prior to the first dose of study drug, ingested grapefruit or grapefruit juice, apple or orange juice, vegetables from the mustard green family or charbroiled meats
About this study
Official title: A Phase 1 Study Investigating the Pharmacokinetics of FV-100 With and Without Ritonavir in Healthy Volunteers
This study is designed to evaluate the potential for a PK drug-drug interaction between FV-100 and ritonavir. The study is a single-center, open-label, randomized, 2-way crossover design in healthy volunteers.
- Conditions
- Acute Herpes Zoster
- Being tested
- FV-100
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FV-100Drug
Subjects will be randomized to one of two treatment sequences: AB or BA.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Regimen A | Experimental | FV-100 400mg OD as a single dose fasted (>/= 8 hours) Receives: Drug: FV-100 |
| Treatment Regimen B | Experimental | FV-100 400 mg OD as a single dose with ritonavir 200mg OD as a single fasted dose (>/= 8 hours) Receives: Drug: FV-100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The evaluation of safety of a single oral dose of FV-100 alone and when combined with a single oral dose of ritonavir
Measuring the Cmax, Tmax and AUC for FV-100 pk profile
Measured: Two weeks
The evaluation of the pharmacokinetics of FV-100 and CF-1743 following a single oral dose of FV-100 administered alone and with a single oral dose of ritonavir
Measuring the Cmax, Tmax and AUC for FV-100 pk profile when dosed with ritonavir
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study startFeb 2015
- Primary completionApr 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Herpes ZosterStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ContraVir Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02322957
- Sponsor's protocol ID
- CTRV-FV-1-008
- Status last verified
- Sep 2015
- First submitted
- 15 Dec 2014
- Last updated
- 1 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study Investigating the Pharmacokinetics of FV-100 With and Without Ritonavir in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02322957
- Acronym / sponsor ID
- CTRV-FV-1-008
- Conditions
- Acute Herpes Zoster
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- ContraVir Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 23 Dec 2014 (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 evaluate the potential for a PK drug-drug interaction between FV-100 and ritonavir. The study is a single-center, open-label, randomized, 2-way crossover design in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Regimen A | Experimental | Drug: FV-100FV-100 400mg OD as a single dose fasted (>/= 8 hours) |
| Treatment Regimen B | Experimental | Drug: FV-100FV-100 400 mg OD as a single dose with ritonavir 200mg OD as a single fasted dose (>/= 8 hours) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Capable of giving written informed consent
- Non-tobacco user for at least 3 months prior to selection
- Healthy on the basis of physical examination, medical history, ECG and clinical laboratory testing at screening
Key exclusion criteria (7 listed)
- Infected with Hepatitis A, B, C, or HIV
- History of or any current medical condition which could impact safety of the participant
- A positive urine drug test
- Consumption of more than 2 units of alcoholic beverages per day or more than 14 per week
- Received an investigational drug or vaccine or used an investigational medical device within 3 months or 5 half-lives before the planned start of treatment or prior treatment with FV-100
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 |
|---|---|---|
| FV-100Subjects will be randomized to one of two treatment sequences: AB or BA. | Drug | Treatment Regimen A, Treatment Regimen B |
Primary outcome
The evaluation of safety of a single oral dose of FV-100 alone and when combined with a single oral dose of ritonavir
Time frame: Two weeks
Measuring the Cmax, Tmax and AUC for FV-100 pk profile
The evaluation of the pharmacokinetics of FV-100 and CF-1743 following a single oral dose of FV-100 administered alone and with a single oral dose of ritonavir
Time frame: Two weeks
Measuring the Cmax, Tmax and AUC for FV-100 pk profile when dosed with ritonavir
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 1 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FV-100 in people with Acute Herpes Zoster, run by ContraVir Pharmaceuticals, Inc..
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 3 inclusion and 7 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 1 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The evaluation of safety of a single oral dose of FV-100 alone and when combined with a single oral dose of ritonavir (time frame: Two weeks). 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 1 Oct 2015.