Title
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
Phase
Phase 1Lead Sponsor
Hepion PharmaceuticalsStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Acute Herpes ZosterIntervention/Treatment
fv-100 ...Study Participants
24This 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.
Subjects will be randomized to one of two treatment sequences: AB or BA.
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
