A Study to Evaluate Orally-Administered Oseltamivir and Intravenous Zanamivir in Healthy Subjects

Phase 1, Open-Label Study to Evaluate Potential Pharmacokinetic Interactions Between Orally-Administered Oseltamivir and Intravenous Zanamivir in Healthy Thai Adult Subjects

This study is a 4 period study to see if there is any interaction between Orally-Administered Oseltamivir and Intravenous Zanamivir in Healthy Thai Adult Subjects

Study Overview

• Status: Withdrawn
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: Oseltamivir and Intravenous Zanamivir

• Study Type: Interventional
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Healthy Volunteer(s)confirmed by physical exam, clinical labs, ECGs, and vitals
• Must be woman of non-childbearing potential or willing to abstain from intercourse for two weeks prior to study drug administration and throughout the study or be willing to use two acceptable methods of birth control.

Exclusion criteria:

• Subjects with history of certain heart problems or subjects with Hepatitis B, C or HIV.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oseltamivir 150mg and zanamivir 50mg/hour; Oseltamivir1 150mg PO q12h for 5 doses + Zanamivir IV continuous infusion at 50mg/hour for 72 hours	Drug: Oseltamivir and Intravenous Zanamivir; Oseltamivir will be administered PO q12h for 3 days (for a total of 5 doses ending the morning of day 3. Both drugs will be administered simultaneously starting on Day 1 of Period 3. Zanamivir will be administered IV q12h for 3 days (for a total of 5 doses ending on the morning of day 3. Zanamivir to be given four (4) hours after the oral dose of oseltamivir and infused over 30 minutes.
Experimental: Zanamivir IV 50mg/hour; Zanamivir IV continuous infusion 50mg/hour for 16 hours (total dose of 800mg)	Drug: Oseltamivir and Intravenous Zanamivir; Oseltamivir will be administered PO q12h for 3 days (for a total of 5 doses ending the morning of day 3. Both drugs will be administered simultaneously starting on Day 1 of Period 3. Zanamivir will be administered IV q12h for 3 days (for a total of 5 doses ending on the morning of day 3. Zanamivir to be given four (4) hours after the oral dose of oseltamivir and infused over 30 minutes.
Experimental: Oseltamivir 150mg and zanamivir 600mg; Oseltamivir 150mg PO q12h for 5 doses + Zanamivir 600mg IV q12h	Drug: Oseltamivir and Intravenous Zanamivir; Oseltamivir will be administered PO q12h for 3 days (for a total of 5 doses ending the morning of day 3. Both drugs will be administered simultaneously starting on Day 1 of Period 3. Zanamivir will be administered IV q12h for 3 days (for a total of 5 doses ending on the morning of day 3. Zanamivir to be given four (4) hours after the oral dose of oseltamivir and infused over 30 minutes.
Active Comparator: Oseltamivir 150mg; Oseltamivir 150mg PO q12h for 3 days	Drug: Oseltamivir and Intravenous Zanamivir; Oseltamivir will be administered PO q12h for 3 days (for a total of 5 doses ending the morning of day 3. Both drugs will be administered simultaneously starting on Day 1 of Period 3. Zanamivir will be administered IV q12h for 3 days (for a total of 5 doses ending on the morning of day 3. Zanamivir to be given four (4) hours after the oral dose of oseltamivir and infused over 30 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Oseltamivir carboxylate levels: Cmax and AUC(0-12)-	Period 2: Day 1, 2 & 3. Period 3: Day 1, 2 & 3. Period 4: Day 1, 2 & 3.

Secondary Outcome Measures

Outcome Measure	Time Frame
Oseltamivir: Cmax, AUC(0-12)& C12. Oseltamivir carboxylate: C12, AUC(0-24)& t1/2.	Period 2-4 Day 1-3
Zanamivir: Cmax, AUC(0-12), C12, t1/2, CL, tmax & V2 .	Period 1, 3 & 4 Day 1-3
Safety:labs, vitals, ECGs & AEs.	Period 1-4, Days 1-4.

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Anticipated): October 1, 2007
• Study Completion (Anticipated): October 1, 2007

Study Registration Dates

• First Submitted: October 4, 2007
• First Submitted That Met QC Criteria: October 4, 2007
• First Posted (Estimate): October 8, 2007

Study Record Updates

• Last Update Posted (Estimate): May 31, 2010
• Last Update Submitted That Met QC Criteria: May 27, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: zanamivir,; influenza virus,; healthy volunteer,; PK, drug interaction,; IV, and oseltamivir.
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Zanamivir; Oseltamivir
• Other Study ID Numbers: NAI108166