Pharmacologic Study of Oseltamivir in Healthy Volunteers

NCT00439530 | Completed Phase 1 DMC

• 2 other identifiers: SEA Trial 0002SEA ICRN
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Avian Influenza A Virus

Keywords

oseltamivir; pharmacokinetics; probenecid; avian influenza

Outcome Measures

Primary Outcomes (1)

• AUC 0-12 hrs.

  12 hour

Secondary Outcomes (4)

• AUC 12-24 hrs.

  24 hrs

• C max

  24 hrs

• t max

  24 hrs

• t 1/2

  24 hrs

Interventions

oseltamivir DRUG

probenecid DRUG

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Southeast Asia Influenza Clinical Research Network: collaborator

Study Sites (1)

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

Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Influenza in Birds

Interventions

Oseltamivir; Probenecid

Condition Hierarchy (Ancestors)

Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Infections; Bird Diseases; Animal Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfonamides; Sulfones; Sulfur Compounds

Study Officials

• Yupaporn Wattanagoon, DTM & H

  Associate Professor, Department of Clinical Tropical Medicine Faculty of Tropical Medicine, Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 21, 2007
• First Posted: February 23, 2007
• Study Start: November 1, 2006
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: July 28, 2009

Record last verified: 2006-11

Locations

TH (1)