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

Acute Herpes Zoster Clinical Trial

Official title:

A Phase 1 Study Investigating the Pharmacokinetics of FV-100 With and Without Ritonavir in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02322957
• Other study ID #: CTRV-FV-1-008
• Status: Completed
• Phase: Phase 1
• First received: December 15, 2014
• Last updated: September 30, 2015
• Start date: February 2015
• Est. completion date: July 2015

Study information

• Verified date: September 2015
• Source: ContraVir Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Herpes Zoster
• Herpes Zoster

Intervention

Drug:
• FV-100
Subjects will be randomized to one of two treatment sequences: AB or BA.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
ContraVir Pharmaceuticals, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No