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

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.

Study Overview

• Status: Completed
• Conditions: Acute Herpes Zoster
• Intervention / Treatment: Drug: FV-100

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 51 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: ContraVir Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: December 15, 2014
• First Submitted That Met QC Criteria: December 17, 2014
• First Posted (Estimate): December 23, 2014

Study Record Updates

• Last Update Posted (Estimate): October 1, 2015
• Last Update Submitted That Met QC Criteria: September 30, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Virus Diseases; Infections; DNA Virus Infections; Herpesviridae Infections; Varicella Zoster Virus Infection; Herpes Zoster
• Other Study ID Numbers: CTRV-FV-1-008