Drug Interaction Study With RV521 in Healthy Volunteer Subjects

• Status: Completed
• Trial end date: 2019-03-17
• Target enrollment: 0
• Participant gender: All

Summary

The main aim of this study is to determine whether RV521 interacts with any other medication using four licensed medicines (midazolam, itraconazole, rifampicin and verapamil) that are known to have specific effects on enzymes and transporter proteins that influence the absorption of drugs

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: ReViral Ltd
• Treatments: Hydroxyitraconazole; Itraconazole; Midazolam; Rifampin; Verapamil

Criteria

Inclusion Criteria:

• Age 18 to 45 years, inclusive

• Willing to comply with protocol defined contraception requirements

• In good health with no history of major medical conditions

• A body mass index (BMI) of 18 - 25 kg/m2

Exclusion Criteria:

• Evidence of any clinically significant or currently active major medical condition

• Positive test for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab)

• Not willing to comply with protocol defined restrictions for intake of drugs of abuse, alcohol, nicotine-containing products, medication (prescription, OTC, herbal, vitamins/minerals etc) and specified food and drink products