A Phase 1 interventional study of FV-100 in Acute Herpes Zoster, sponsored by ContraVir Pharmaceuticals, Inc.. Completed. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-10-01.
Sponsored by ContraVir Pharmaceuticals, Inc. · Phase 1, Interventional, and Treatment
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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.
299 studies on the registry are indexed under Herpes Zoster; 55 are open to participants now.
This study's planned enrollment of 24 is below the median of 160 across 247 interventional studies indexed under Herpes Zoster.
Browse Herpes Zoster studies →ContraVir Pharmaceuticals, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.
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Inclusion Criteria:
Exclusion Criteria:(must NOT meet the following)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FV-100 400mg OD as a single dose fasted (\>/= 8 hours)
Drug: FV-100
FV-100 400 mg OD as a single dose with ritonavir 200mg OD as a single fasted dose (\>/= 8 hours)
Drug: FV-100
Subjects will be randomized to one of two treatment sequences: AB or BA.
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
Time frame: 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
Time frame: Two weeks
No study locations are listed for this record.
The record gives a start of Feb 2015, a primary completion of Apr 2015 and a completion of Jul 2015. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: FV-100
ContraVir Pharmaceuticals, Inc.