A Study Investigating the Pharmacokinetics of FV-100 With and Without Ritonavir in Healthy Volunteers

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1 Study Investigating the Pharmacokinetics of FV-100 With and Without Ritonavir in Healthy Volunteers

Conditions
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Acute Herpes Zoster

Intervention / Treatment
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* Drug: FV-100


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria:(must NOT meet the following) 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Regimen A<br>FV-100 400mg OD as a single dose fasted (>/= 8 hours) | Drug: FV-100<br>* Subjects will be randomized to one of two treatment sequences: AB or BA.<br>|
| Experimental: Treatment Regimen B<br>FV-100 400 mg OD as a single dose with ritonavir 200mg OD as a single fasted dose (>/= 8 hours) | Drug: FV-100<br>* Subjects will be randomized to one of two treatment sequences: AB or BA.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Two weeks |