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

Phase 1

Completed

• Conditions: Acute Herpes Zoster
• Interventions: Drug: FV-100

• Registration Number: NCT02322957
• Lead Sponsor: ContraVir Pharmaceuticals, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-12-15
• Study First Submitted QC: 2014-12-17
• Study First Posted: 2014-12-23
• Study Start: 2015-02
• Primary Completion: 2015-04
• Study Completion: 2015-07
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-30
• Last Update Posted: 2015-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment Regimen B	FV-100	FV-100 400 mg OD as a single dose with ritonavir 200mg OD as a single fasted dose (\>/= 8 hours)
Treatment Regimen A	FV-100	FV-100 400mg OD as a single dose fasted (\>/= 8 hours)

Primary Outcome Measures

Name	Time	Method
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	Two weeks	Measuring the Cmax, Tmax and AUC for FV-100 pk profile when dosed with ritonavir
The evaluation of safety of a single oral dose of FV-100 alone and when combined with a single oral dose of ritonavir	Two weeks	Measuring the Cmax, Tmax and AUC for FV-100 pk profile