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Completed

NCT Number: NCT02322957

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

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FV-100

Drug

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

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

    Time frame: Two weeks

    Measuring the Cmax, Tmax and AUC for FV-100 pk profile

  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

    Time frame: Two weeks

    Measuring the Cmax, Tmax and AUC for FV-100 pk profile when dosed with ritonavir

Sponsors and collaborators

Lead sponsor

ContraVir Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Dec 23, 2014
Registry last updated
Oct 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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