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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02322957

Enrollment

Registered

2014-12-23

Start date

2015-02-28

Completion date

2015-07-31

Last updated

2015-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Herpes Zoster

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.

Interventions

DRUGFV-100

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
The evaluation of safety of a single oral dose of FV-100 alone and when combined with a single oral dose of ritonavir	Two weeks	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	Two weeks	Measuring the Cmax, Tmax and AUC for FV-100 pk profile when dosed with ritonavir

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026