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

C

ContraVir Pharmaceuticals

Status and phase

Completed
Phase 1

Conditions

Acute Herpes Zoster

Treatments

Drug: FV-100

Study type

Interventional

Funder types

Industry

Identifiers

NCT02322957
CTRV-FV-1-008

Details and patient eligibility

About

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.

Enrollment

24 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

24 participants in 2 patient groups

Treatment Regimen A
Experimental group
Description:
FV-100 400mg OD as a single dose fasted (\>/= 8 hours)
Treatment:
Drug: FV-100
Treatment Regimen B
Experimental group
Description:
FV-100 400 mg OD as a single dose with ritonavir 200mg OD as a single fasted dose (\>/= 8 hours)
Treatment:
Drug: FV-100

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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