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

NCT ID: NCT02322957

Last Updated: 2015-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2015-07-31

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.

Conditions

Acute Herpes Zoster

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Regimen A

FV-100 400mg OD as a single dose fasted (\>/= 8 hours)

Group Type: EXPERIMENTAL

FV-100

Intervention Type: DRUG

Subjects will be randomized to one of two treatment sequences: AB or BA.

Treatment Regimen B

FV-100 400 mg OD as a single dose with ritonavir 200mg OD as a single fasted dose (\>/= 8 hours)

Group Type: EXPERIMENTAL

FV-100

Intervention Type: DRUG

Subjects will be randomized to one of two treatment sequences: AB or BA.

Interventions

FV-100

Subjects will be randomized to one of two treatment sequences: AB or BA.

Intervention Type: DRUG

Eligibility 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ContraVir Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CTRV-FV-1-008

Identifier Type: -

Identifier Source: org_study_id