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

NCT02322957 | Completed Phase 1

• 1 other identifier: CTRV-FV-1-008
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Treatment Regimen A

EXPERIMENTAL

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

Drug: FV-100

Treatment Regimen B

EXPERIMENTAL

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

Drug: FV-100

Interventions

FV-100 DRUG

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

Treatment Regimen A; Treatment Regimen B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ContraVir Pharmaceuticals, Inc.: lead

MeSH Terms

Interventions

FV-100

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2014
• First Posted: December 23, 2014
• Study Start: February 1, 2015
• Primary Completion: April 1, 2015
• Study Completion: July 1, 2015
• Last Updated: October 1, 2015

Record last verified: 2015-09