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

ContraVir Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Acute Herpes Zoster

Treatments

Drug: FV-100

Study type

Interventional

Funder types

Industry

Identifiers

NCT02322957

CTRV-FV-1-008

Details and patient eligibility

About

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.

Enrollment

24 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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