Back to resultsA Study Investigating the Pharmacokinetics of FV-100 With and Without Ritonavir in Healthy Volunteers
Primary Purpose
Acute Herpes Zoster
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
FV-100
Sponsored by
About this trial
This is an interventional treatment trial for Acute Herpes Zoster
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:(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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Treatment Regimen A
Treatment Regimen B
Arm Description
FV-100 400mg OD as a single dose fasted (>/= 8 hours)
FV-100 400 mg OD as a single dose with ritonavir 200mg OD as a single fasted dose (>/= 8 hours)
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02322957
First Posted
December 15, 2014
Last Updated
September 30, 2015
Sponsor
ContraVir Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02322957
Brief Title
A Study Investigating the Pharmacokinetics of FV-100 With and Without Ritonavir in Healthy Volunteers
Official Title
A Phase 1 Study Investigating the Pharmacokinetics of FV-100 With and Without Ritonavir in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ContraVir Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Herpes Zoster
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment Regimen A
Arm Type
Experimental
Arm Description
FV-100 400mg OD as a single dose fasted (>/= 8 hours)
Arm Title
Treatment Regimen B
Arm Type
Experimental
Arm Description
FV-100 400 mg OD as a single dose with ritonavir 200mg OD as a single fasted dose (>/= 8 hours)
Intervention Type
Drug
Intervention Name(s)
FV-100
Intervention Description
Subjects will be randomized to one of two treatment sequences: AB or BA.
Primary Outcome Measure Information:
Title
The evaluation of safety of a single oral dose of FV-100 alone and when combined with a single oral dose of ritonavir
Description
Measuring the Cmax, Tmax and AUC for FV-100 pk profile
Time Frame
Two weeks
Title
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
Description
Measuring the Cmax, Tmax and AUC for FV-100 pk profile when dosed with ritonavir
Time Frame
Two weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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:(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
12. IPD Sharing Statement
Learn more about this trial
A Study Investigating the Pharmacokinetics of FV-100 With and Without Ritonavir in Healthy Volunteers
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