Pharmacokinetic Study of Oseltamivir and Intravenous Zanamivir in Healthy Adults

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Due in part to widespread availability of oseltamivir and clinical experience using oseltamivir to treat H5N1 influenza virus infections, many strains of influenza have become resistant to it. Other reliable methods of treating H5N1 must be identified in case of a pandemic. One such option is intravenous zanamivir used in combination with oseltamivir. The primary purpose of this study is to evaluate the interaction between oral oseltamivir and intravenous zanamivir administered as either a continuous or intermittent infusion in healthy adults.

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

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Johns Hopkins Bloomberg School of Public Health
• Treatments: Oseltamivir; Zanamivir

Criteria

Inclusion Criteria:

• Good general health

• Body mass index between 17 - 32 kg/m^2

• Body weight of at least 37 kg

• Able to read, comprehend, and write at a sufficient level to complete study-related materials

• Normal ECG with QTC less than 450 msec as judged by cardiologist

• Willing and ability to comply with the study protocol for the duration of the trial

Exclusion Criteria:

• History of cardiac disease or abnormality. More information on this criterion can be found in the protocol.

• Family history of sudden cardiac death

• HIV-infected

• Hepatitis C virus infected

• Positive for hepatitis B surface antigen (HBsAg)

• History of renal disease, hepatic disease, and/or cholecystectomy

• Evidence of active substance abuse

• History of alcohol or substance abuse or dependence within 6 months prior to study entry. More information on this criterion can be found in the protocol.

• Use of prescription or non-prescription drugs, except paracetamol, at doses of up to 2 g/day. More information on this criterion can be found in the protocol.

• Use of FluMist, inactivated influenza vaccine, or any other anti-influenza antiviral medications within 14 days prior to study entry

• Participated in a clinical trial and received a drug or new chemical entity within 30 days or five half-lives prior to study entry.

• Unwilling to abstain from ingesting alcohol within 48 hours prior to study entry until collection of the final pharmacokinetic sample during each period

• Donated blood to the extent that participation in this study would result in excess of 300 mL donated within a 30 day period

• History of allergy to the study drug or drugs of this class. More information on this criterion can be found in the protocol.

• Unstable medical condition that, in the opinion of the investigator, would interfere with the study

• Anyone that, in the opinion of the investigator, has a risk of non-compliance with study procedures

• AST or ALN of at least 1.5 ULN

• Certain abnormal laboratory values

• Agree to use effective methods of birth control. More information on this criterion can be found in the protocol.

• Pregnant or breastfeeding