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

NCT00540501 | Withdrawn Phase 1

• 1 other identifier: NAI108166
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy Subjects

Keywords

zanamivir,; influenza virus,; healthy volunteer,; PK, drug interaction,; IV, and oseltamivir.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

Study Arms (4)

Oseltamivir 150mg and zanamivir 50mg/hour

EXPERIMENTAL

Oseltamivir1 150mg PO q12h for 5 doses + Zanamivir IV continuous infusion at 50mg/hour for 72 hours

Drug: Oseltamivir and Intravenous Zanamivir

Zanamivir IV 50mg/hour

EXPERIMENTAL

Zanamivir IV continuous infusion 50mg/hour for 16 hours (total dose of 800mg)

Drug: Oseltamivir and Intravenous Zanamivir

Oseltamivir 150mg and zanamivir 600mg

EXPERIMENTAL

Oseltamivir 150mg PO q12h for 5 doses + Zanamivir 600mg IV q12h

Drug: Oseltamivir and Intravenous Zanamivir

Oseltamivir 150mg

ACTIVE COMPARATOR

Oseltamivir 150mg PO q12h for 3 days

Drug: Oseltamivir and Intravenous Zanamivir

Interventions

Oseltamivir and Intravenous Zanamivir DRUG

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.

Oseltamivir 150mg; Oseltamivir 150mg and zanamivir 50mg/hour; Oseltamivir 150mg and zanamivir 600mg; Zanamivir IV 50mg/hour

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Interventions

Oseltamivir

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 4, 2007
• First Posted: October 8, 2007
• Study Start: October 1, 2007
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: May 31, 2010

Record last verified: 2010-05