Influenza Clinical Trial
Official title:
Phase 1, Open-Label Study to Evaluate Potential Pharmacokinetic Interactions Between Orally-Administered Oseltamivir and Intravenous Zanamivir in Healthy Thai Adult Subjects
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.
It is very likely that during an influenza pandemic, intravenous zanamivir will be used in
combination with oseltamivir. Although the potential for a drug interaction between the two
drugs is very low, the likelihood of coadministration combined with the common route of
renal clearance of both drugs and the current lack of information on the organic anion
transporter polypeptides (OATP) inhibition potential of zanamivir in vivo warrants
verification of a lack of an interaction. This study will provide clinical guidance for the
use of intravenous zanamivir in settings where oral oseltamivir is commonly used, such as
areas in which human cases of H5N1 have been reported.
The total duration of study participation is approximately 13 weeks. Each participant will
have a screening visit, four treatment steps, and a follow-up visit. The screening visit to
determine enrollment eligibility will be conducted within 45 days prior to receiving the
first dose. Participants will be randomized to receive either Regimen A or B for Step 1.
Participants who received Regimen A will receive Regimen B in Step 2 and vice versa. After
completing Step 2, all participants will continue with Regimens C and D, consecutively, in
Steps 3 and 4, with at least 3 days between each step. A follow-up visit will occur 7-10
days after completing the last treatment assessments or withdrawing from the study.
Regimen A consists of continuous intravenous zanamivir infusion (800 mg) for 16 hours.
Regimen B consists of 150 mg oral oseltamivir tablets taken five times over 3 days. Regimen
C consists of 150 mg oral oseltamivir tablets taken five times over 3 days plus continuous
intravenous zanamivir infusion (3600 mg) for 36 hours. Regimen D consists of 150 mg oral
oseltamivir tablets taken five times over 3 days plus intermittent intravenous zanamivir
infusion received in five 30 minute intervals (3000 mg total).
Blood and urine collection, vital signs, pharmacokinetic sampling, adverse event assessment,
and pregnancy test for females will occur at each step in the study. The follow-up visit
will involve blood and urine collection, vital signs, adverse event assessment, and
pregnancy test for females.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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