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Pharmacologic Study of Oseltamivir in Healthy Volunteers (SEA002)

Primary Purpose

Avian Influenza A Virus

Status
Completed
Phase
Phase 1
Locations
Thailand
Study Type
Interventional
Intervention
oseltamivir
probenecid
Sponsored by
Mahidol University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional health services research trial for Avian Influenza A Virus focused on measuring oseltamivir, pharmacokinetics, probenecid, avian influenza

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • healthy with no underlying chronic disease
  • normal baseline laboratory screening
  • no regular prescribed medication used in the past 30 days and no over-the-counter medication in the past week
  • agree to abstain from self-medication during the study
  • negative urine pregnancy test for females and agreement that they will not try to become pregnant until 1 month after the study is completed
  • only use non-hormonal methods of contraception for females
  • non-smoker for the last 30 days and for duration of the study
  • no consumption of alcohol for the last 30 days and for duration of the study
  • no use of recreational drugs for the last 30 days and for duration of the study

Exclusion Criteria:

  • known hypersensitivity to oseltamivir and/or probenecid
  • Hepatitis B virus surface antigen positive
  • presence of intercurrent illness or any condition which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study

Sites / Locations

  • Bangkok Hospital for Tropical Diseases Research Unit, Faculty of Tropical Medicine, Mahidol University

Outcomes

Primary Outcome Measures

AUC 0-12 hrs.

Secondary Outcome Measures

AUC 12-24 hrs.
C max
t max
t 1/2

Full Information

First Posted
February 21, 2007
Last Updated
July 24, 2009
Sponsor
Mahidol University
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID), Southeast Asia Influenza Clinical Research Network
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1. Study Identification

Unique Protocol Identification Number
NCT00439530
Brief Title
Pharmacologic Study of Oseltamivir in Healthy Volunteers
Acronym
SEA002
Official Title
Pharmacologic Study of Oseltamivir in Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mahidol University
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID), Southeast Asia Influenza Clinical Research Network

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
"Pharmacologic Study of Oseltamivir in Healthy Volunteers" is a Phase I study in which 8 to 32 adult healthy Thai volunteers will be randomized to one of four drug doses and regimens within each of 4 visits. The study is being conducted at the Bangkok Hospital of Tropical Diseases Research Unit, Faculty of Tropical Medicine, and commenced enrolling healthy volunteers on 23 November 2006. The duration of the study is expected to be approximately four months. The goals of this study are to assess the use of loading dose oseltamivir and the concomitant use of probenecid and to characterize the pharmacokinetic properties of oseltamivir in Thai subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Avian Influenza A Virus
Keywords
oseltamivir, pharmacokinetics, probenecid, avian influenza

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
oseltamivir
Intervention Type
Drug
Intervention Name(s)
probenecid
Primary Outcome Measure Information:
Title
AUC 0-12 hrs.
Time Frame
12 hour
Secondary Outcome Measure Information:
Title
AUC 12-24 hrs.
Time Frame
24 hrs
Title
C max
Time Frame
24 hrs
Title
t max
Time Frame
24 hrs
Title
t 1/2
Time Frame
24 hrs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: healthy with no underlying chronic disease normal baseline laboratory screening no regular prescribed medication used in the past 30 days and no over-the-counter medication in the past week agree to abstain from self-medication during the study negative urine pregnancy test for females and agreement that they will not try to become pregnant until 1 month after the study is completed only use non-hormonal methods of contraception for females non-smoker for the last 30 days and for duration of the study no consumption of alcohol for the last 30 days and for duration of the study no use of recreational drugs for the last 30 days and for duration of the study Exclusion Criteria: known hypersensitivity to oseltamivir and/or probenecid Hepatitis B virus surface antigen positive presence of intercurrent illness or any condition which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yupaporn Wattanagoon, DTM & H
Organizational Affiliation
Associate Professor, Department of Clinical Tropical Medicine Faculty of Tropical Medicine, Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bangkok Hospital for Tropical Diseases Research Unit, Faculty of Tropical Medicine, Mahidol University
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand

12. IPD Sharing Statement

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Pharmacologic Study of Oseltamivir in Healthy Volunteers

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