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CompletedNCT02322957Updated Oct 1, 2015

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

A Phase 1 interventional study of FV-100 in Acute Herpes Zoster, sponsored by ContraVir Pharmaceuticals, Inc.. Completed. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-10-01.

Sponsored by ContraVir Pharmaceuticals, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Acute Herpes Zoster

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03

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    Treatment Regimen A

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

    Drug: FV-100

  • Experimental
    Treatment Regimen B

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

    Drug: FV-100

Interventions

  • DrugFV-100

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

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: Two weeks

  2. 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

    Time frame: Two weeks

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT02322957
Lead sponsor
ContraVir Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Dec 23, 2014
Start date
Feb 2015
Primary completion
Apr 2015
Completion
Jul 2015
Last update
Oct 1, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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